Axion Research Peptides · Data study · September 2026
The research-peptide market in the United States and Brazil, measured
Prices per milligram across 12 vendors, who actually publishes a lot-matched third-party certificate, what customs and regulators intercept, and where FDA and ANVISA stand today on compounding BPC-157, TB-500, MOTS-c, Semax and Epithalon.
Published 11 Sep 2026Prices observed 10–11 Sep 2026227 cited sourcesResearch use only · not medical advice
18%of suspect GLP-1 API shipments into the US were stopped by FDA (44 of 239, Sep 2023–Jan 2025)
130,609GLP-1 pens seized by Brazil's Receita Federal in the first half of 2026, up from 8 in all of 2023
11.4 momedian lag between an FDA approval and the ANVISA registration of the same drug (11 pairs)
6 of 7peptides the FDA advisory committee voted to recommend for the 503A bulks list in July 2026, against FDA staff
1 of 5Brazilian vendors that publishes a lot-matched certificate from a named third-party lab
$32Min crypto paid to gray-market peptide vendors in Q1 2026, from about $1M per quarter in 2024
Three things stand out. First, the two markets are diverging in product: GLP-1 analogues have almost disappeared from US research-peptide storefronts after the 2024–2026 FDA warning letters, while in Brazil they are the center of an informal market that analysts size at roughly half of all GLP-1 spending. Second, certificate practice, not price, is the real dividing line between vendors: most publish a purity claim, few publish a lot-matched document from a named laboratory, and peer-reviewed testing has found vials at a fraction of the claimed purity. Third, the regulators are moving in opposite orders. The FDA cut compounded tirzepatide first and semaglutide second; ANVISA banned compounded semaglutide and left tirzepatide compounding open under stricter rules.
Disclosure. This report is published by Axion Research Peptides and its Brazilian branch, Axion Peptides (axionbiolab.com). Axion is listed first in both vendor tables by the publisher's choice, not by measured market share; every price and certificate claim about Axion is held to the same evidence standard as the competitors', and the gaps found on Axion's own pages are recorded in section 11.
02United States market overview
The US research-peptide channel sells lyophilized peptides labelled "for research use only" directly to consumers, outside the FDA approval system. Two of the largest vendors of the 2023–2025 period are gone: Peptide Sciences closed on 6 March 2026 and Amino Asylum went offline after an FDA action in June 2025. The live vendors below were selected by visibility in independent comparison articles and community discussion; no audited traffic data exists for this channel.
≥99% HPLC, stated on every product page; site also claims Mass Spectrometry identity confirmation and LAL endotoxin testing <0.5 EU/mg
not named
no
yes
Not published per lot before purchase. The CoA page states the batch-specific CoA is 'available on request - contact our team with your order number a…
>99%, stated in the spec block of essentially every product page
Vanguard Laboratory
yes
no
Lot-specific CoA PDFs are published directly on product pages before purchase for many SKUs (confirmed on GHK-Cu 50 mg, AOD-9604, PE-22-28 and several…
≥99% purity guaranteed, stated across product pages and the Quality Assurance page
Janoshik Analytical
inconsistent
no
Inconsistent on the vendor's own site. Product pages carry a 'Check Lab Report' link and the FAQ says CoAs are published on an Independent Test Result…
≥99% HPLC for the 'Premium Lyophilized' tier and ≥98.5% for the 'Non-Lyophilized' tier (FAQ page)
not named
yes
no
Public per-lot CoAs published directly on each product page as individual linked PDFs covering purity, sterility and endotoxin per lot number. This wa…
99% or higher, verified by HPLC-MS per the About page
not named
yes
no
Public per-batch CoAs on individual product pages before purchase, either as a Download CoA PDF (TB-500, GHK-Cu, MOTS-c, Semax, Epithalon) or embedded…
No blanket company-wide percentage. Site copy states purity is documented per batch on the corresponding Certificate of Analysis, i.e. a per-lot figure rather than an advertised number.
not named
yes
yes
Public, batch-specific 'View Certificate of Analysis (PDF)' link directly on each product page, no login required
Company-wide minimum stated as 96-99% for peptides and ≥98% for SARMs, plus a specific batch-tested percentage printed on each product page: BPC-157 99.43%, TB-500 99.67%, MOTS-c 99.66%, Semax 99.00%, Epitalon 95.32%, NAD+ 99.3% HPLC
MZ Biolabs
yes
no
Public, batch-linked CoA PDFs on the product page and in a dedicated /coas/ index, explicitly with no login required
Purity figures are vendor claims. A 2024 peer-reviewed study (J Med Internet Res) measured a semaglutide vial from an online seller at 7.70% against a 99% claim; treat every number in the second column accordingly.
Market context and enforcement, 2024–2026
No published estimate of the size of the US grey-market research-peptide retail channel was found. Analyst reports size the legal peptide therapeutics market, which is a different and much larger market, and their figures disagree sharply depending on scope: Precedence Research puts global peptide therapeutics at USD 52.59B in 2 208
The best available proxy for grey-market scale is single-vendor revenue: Peptide Sciences was reported to be selling roughly USD 7.4 million per month before its March 2026 closure, attributed to e-commerce analytics firm Grips Intelligence. This is a secondary citation and Grips' own report was not located; treat it as indicati 210
A second scale proxy comes from court filings: federal prosecutors estimated that Paradigm Peptides alone had 54,000 unique customers across all 50 US states and 80 countries before it was shut down in March 2024. 211
FDA warning letter to Swiss Chems dated 2024-12-10 (MARCS-CMS 695663) cited its Semaglutide and Retatrutide products as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, stating that despite 'research chemicals only' labelling, website evidence established the products were intended as drugs for human use. S 212
FDA maintains a standing consumer advisory stating it has warned companies illegally selling unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labelled 'for research purposes' or 'not for human consumption'. This establishes that the research-use-only disclaimer does not 213
Paradigm Peptides owner Matthew Kawa was sentenced on 2026-07-30 to 5 years 10 months (70 months) incarceration plus 1 year supervised release and $78,317.52 restitution, after he and co-defendant Jennifer Stechkober pleaded guilty on 2025-12-10. Stechkober received 16 months. Press reporting adds a $5 million forfeiture and tha 214
FDA issued 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products, announced 2026-03-03. Cited violations included implying sameness with FDA-approved products and obscuring product sourcing by branding compounded drugs with the firm's own name. 165
FDA warning letter to Wholesale Peptide dated 2026-06-17 (MARCS-CMS 729447) cited Prostamax and Gonadorelin as unapproved new drugs, with the letter again stating that RESEARCH USE ONLY and 'not for human consumption' labelling did not prevent the products from being intended as drugs for human use. Enforcement in 2026 has exten 215
Peer-reviewed independent testing found severe quality failures in semaglutide bought from online sellers without prescription. Ashraf et al., J Med Internet Res, published 2024-11-07, made test purchases August-September 2023; all delivered vials were judged probable substandard or falsified products, and three of six ordered i 216
Two of the largest US research-peptide retailers exited the market: Amino Asylum went permanently offline after an FDA action reported in June 2025, and Peptide Sciences posted a voluntary closure notice on 2026-03-06 and went dark the same day with no stated refund process. Both events are widely reported across secondary sourc 217
03Brazilian market overview
Brazil has no legal category for research peptides sold to individuals. ANVISA's 2 July 2026 alert states that injectable peptides sold on social media and websites are irregular, that no company had even applied to regularize them, and that "research use only" labelling does not permit sale for human use. The market nevertheless exists, sells in reais over Pix, and is growing on the back of the GLP-1 wave.
Site-wide: 'Materiais com pureza >=97%, verificados por HPLC'. Per-product spec sheets state 'Pureza: >=98% por HPLC' for most SKUs (MOTS-C listed at >=97%). Vendor claim.
Frontage Laboratories
yes
yes
Publishes a per-lot COA. Homepage promises 'certificado de analise (COA) por lote e rastreabilidade completa'. Product pages carry a Certificado de An…
Declines to publish a blanket percentage. Site states 'Pureza e uma propriedade do lote, nao do composto'; the analytical method and the manufacturer-declared percentage come with the COA. Vendor claim.
not named
no
no
Per-lot, on request only. Every vial is identified by lot number; the chemical-analysis document is supplied by the manufacturer when the buyer quotes…
Site-wide marketing claim '99,9% de Pureza Garantida' in the page title and on the homepage. No HPLC figure or method is given per product. Vendor claim.
not named
no
no
No COA published and no per-lot document offered on the storefront as seen. No lab named.
No purity percentage published. Positions on provenance instead: 'curadoria de procedencia', products 'originais, lacrados e rastreados'. Vendor claim.
not named
no
no
No COA published, no per-lot document offered, no lab named.
'Pureza >= 99%, HPLC verificado' on the homepage; each product description repeats 'Pureza >= 99% verificada por HPLC, conforme documentacao do lote'. Vendor claim.
not named
no
no
Product copy refers to 'documentacao do lote' but no COA, lot number or certificate is published, and no request channel for one is offered. No lab na…
The two largest resellers by catalogue size carry no GLP-1 analogues at all (checked item by item across 209 and 161 listings); the other three, including Axion, do.
Market context and enforcement, 2024–2026
Anvisa issued a public alert on 2 July 2026 stating that injectable peptides sold on social media and on the internet are illegal in Brazil, have no sanitary registration and cannot be sold for health or aesthetic use. It named GHK-Cu, BPC-157, TB-500, CJC-1295 and ipamorelina as not regularised in any category, neither as medic 218
Coverage of the same Anvisa alert adds that the agency acted after the products circulated on Instagram and TikTok, where posts publish dosing schedules, pair results with before-and-after images without scientific control, and point buyers to foreign websites. Anvisa states the products carry no guarantee of safety, quality, co 219
Jornal Opcao reported that the clandestine peptide market reached Goiania and that health authorities there were receiving about two reports (denuncias) per week. The piece states the compounds enter Brazil by contraband, are sold through influencers and aesthetic clinics, and are often applied without the patient knowing what t 220
Anvisa told Futuro da Saude that, as of May 2026, not a single company request or study had been submitted to the agency to regularise these peptides as food supplements, and that selling food products for therapeutic or wellness purposes without regularisation is a sanitary infraction. A market source in the same piece argues A 221
Exame reported that BPC-157 is prohibited in Brazil and that in October 2024 Anvisa banned the sale and compounding of the so-called chips da beleza, hormone implants that could contain peptides. It notes TB-500 originates in veterinary use (racehorses) and is now replicated in informal markets, and cites Zion Market Research pr 222
Therapeutic peptides worldwide moved US$140.9 billion in 2025 and are expected to reach US$164 billion in 2026, with Grand View Research projecting US$294.6 billion by 2033 at 8.7% CAGR. The article is explicit that this figure covers the entire pharmaceutical peptide market, including approved medicines for serious disease, and 223
Compounded semaglutide: Anvisa published Nota Tecnica 200/2025 and Despacho 97/2025 on 25 August 2025, which in practice prohibited compounding of synthetic semaglutide by magistral pharmacies. The note allows import of synthetic GLP-1 active ingredients for compounding only where a product containing the molecule is already reg 224
Legal price anchor for semaglutide in Brazil: Semavy (Mantecorp) went on sale in pharmacies on 4 September 2026 at R$333 for a 1 mg injectable pen covering three months of treatment; Anvisa authorised it on 29 July 2026 alongside four other brands (Zempneo, Orsema, Seemasun, Owozy). Ozivy (EMS), the first national version, has b 225
Independent consumer-complaint signal: Brasil Peptideos holds 21 complaints on Reclame Aqui with a 0% response rate and 17 complaints awaiting reply, is not a verified company and carries no trust seal. Complaints logged between 6 June 2026 and 25 August 2026 include non-delivery, no tracking code 18 days after purchase, goods s 226
The Parana state medical council's dermatology technical chamber drafted a technical note warning against the invasive use of peptides, a professional-body signal independent of Anvisa's regulatory position. 227
04Price index across suppliers
Every observed price was converted to price per milligram so that vial sizes can be compared. "Median" is the median across vendors that sell the compound; "Axion index" is Axion's price per mg as a percentage of that median (below 100 = cheaper than the median vendor). Sizes differ between vendors, and smaller vials cost more per mg, which the index does not correct for.
Median, USD/mgAxion Research Peptides
United States, USD per mg, 6 vendors, observed 10–11 Sep 2026. Bars are the median across vendors; dots mark Axion.
Median, BRL/mgAxion Peptides
Brazil, BRL per mg, 5 vendors, observed 10–11 Sep 2026. Semaglutide, tirzepatide and epithalon at 10 mg or less were sold only by Axion, so their median is a single vendor.
United States, USD per mg
Compound
Vendors
Median $/mg
Range $/mg
Axion $/mg
Axion index
BPC-157
6
$9.45
$6.00 – $11.40
$8.50
90
TB-500
6
$11.70
$4.24 – $14.00
$8.50
73
GHK-CU
6
$1.22
$1.10 – $1.60
$1.60
131
MOTS-C
6
$10.80
$7.00 – $11.60
$11.00
102
SEMAX
5
$2.52
$2.12 – $8.00
not sold
—
EPITHALON
5
$3.76
$2.32 – $5.20
not sold
—
NAD+
5
$0.36
$0.14 – $0.48
$0.14
38
SEMAGLUTIDE
1
$22.00
$22.00 – $22.00
not sold
—
TIRZEPATIDE
1
$6.33
$6.33 – $6.33
$6.33
100
RETATRUTIDE
2
$14.18
$9.67 – $18.70
$9.67
68
Brazil, BRL per mg
Compound
Vendors
Median R$/mg
Range R$/mg
Axion R$/mg
Axion index
BPC-157
4
R$73.25
R$48.00 – R$79.09
R$48.00
66
TB-500
3
R$99.99
R$52.00 – R$109.09
R$52.00
52
GHK-CU
4
R$13.41
R$8.00 – R$16.20
R$8.00
60
MOTS-C
5
R$79.09
R$55.00 – R$103.50
R$60.00
76
SEMAX
3
R$79.99
R$40.00 – R$79.99
R$40.00
50
EPITHALON
1
R$37.00
R$37.00 – R$37.00
R$37.00
100
NAD+
3
R$2.38
R$1.20 – R$2.38
not sold
—
SEMAGLUTIDE
1
R$74.00
R$74.00 – R$74.00
R$74.00
100
TIRZEPATIDE
1
R$61.00
R$61.00 – R$61.00
R$61.00
100
Two structural gaps in Brazil are worth stating: no vendor sells retatrutide below 40 mg, and semax or epithalon at 10 mg exist at one vendor only, because competitors start at 30 to 50 mg. Brazilian prices per mg run roughly 6 to 9 times the US figure at the 11 September 2026 exchange rate of R$5.10, a premium that reflects import risk, customs seizures and the absence of a legal channel rather than a difference in product.
05Importation and enforcement numbers
Neither country publishes a count of research-peptide imports. What exists is enforcement data, congressional testimony, freedom-of-information releases and analyst estimates. Each row below carries its type: official for government documents, news for reported figures, estimate for analyst or academic estimates.
Of 239 semaglutide and tirzepatide API shipments from entities with no FDA-listed product, 44 were stopped and 195 entered the US market (Sep 2023–Jan 2025, testimony to the House Oversight Committee).GLP-1 pens seized by Brazil's Receita Federal: 8 (2023), 2,823 (2024), 32,911 (2025), 130,609 (first half of 2026). Log scale.
United States
Metric
Value
Period
Type
Src
Suspect GLP-1 API shipments from entities with no FDA-listed product (of 2,465 studied)
2,465 shipments studied; 239 problematic shipments from entities with no semaglutide or tirzepatide product listed with FDA
A correction to a common claim: FDA Import Alert 66-41 covers unapproved new drugs generally and never names peptides. The peptide-specific instrument is Import Alert 66-80, which detains GLP-1 bulk substances unless the manufacturer is on a roughly 20-firm "Green List".
Brazil
Metric
Value
Period
Type
Src
GLP-1 pens seized by Receita Federal, by year
2023: 8 units; 2024: 2,823; 2025: 32,911; first half of 2026: 130,609
Brazil's GLP-1 market in the twelve months to April 2026: R$14.6 billion formal (IQVIA) against an estimated R$12.5 billion unmonitored channel (Itaú BBA), about 46% of total spending.
Selected from 40 dated instruments and events compiled for this report. Note that many gov.br pages were offline under Brazilian electoral-period rules while this was researched; where the primary page was unavailable, the pharmacy councils, the official gazette or Agência Brasil are cited.
Portaria SVS/MS 344/1998 published Portaria SVS/MS n 344, de 12/05/1998110 Creates the Brazilian controlled-substance lists A1-A3, B1-B2 and C1-C5. List C5 covers anabolizantes; C1 covers other substances under special control requiring a Receita de Controle Especial with retention of one copy. This is the backbone regime later invok
Lei 9.965/2000 restricts sale of anabolic steroids and anabolic peptides Lei n 9.965, de 27 de abril de 2000111 Dispensing or sale of medicines in the therapeutic group of esteroides ou peptideos anabolizantes requires presentation and retention by the pharmacy of a carbon copy prescription with prescriber identification, CRM/CRO, CPF, address, phone, patient name and a
RDC 67/2007 sets Good Compounding Practices Resolucao RDC n 67, de 08 de outubro de 2007112 Establishes Boas Praticas de Manipulacao de Preparacoes Magistrais e Oficinais para Uso Humano em farmacias, with general requirements in Annex I and specific annexes II-VI covering, among others, sterile preparations and low-therapeutic-index substances. This
ANVISA approves Victoza (liraglutida) for type 2 diabetes Registro de medicamento novo, Novo Nordisk86 First GLP-1 receptor agonist marketed in Brazil, for glycemic control in type 2 diabetes only. ANVISA later stressed that no evidence had been submitted for weight loss with Victoza, which is why Saxenda needed its own registration.
ANVISA approves Ozempic (semaglutida) for type 2 diabetes Registro de produto biologico novo, Novo Nordisk Farmaceutica do Brasil Ltda; bula aprovada pela ANVISA em 06/08/201892 First semaglutide product in Brazil, weekly prefilled pen, as monotherapy when metformin is inappropriate or in combination. The ANVISA news item announces the registration; the approved label carries the 06/08/2018 ANVISA approval date. Sources agree on 2018
ANVISA approves Wegovy (semaglutida 2,4 mg) for obesity and overweight Registro de medicamento, Novo Nordisk. One source dates the enabling DOU resolution to 29/12/2022 with the approval taking effect in January 202396 First weekly GLP-1 analog approved by ANVISA for people with obesity, or overweight with at least one weight-related comorbidity, at BMI thresholds of 30 and 27 kg/m2. Commercial launch in Brazil only came in August 2024, about 19 months after approval. Source
ANVISA approves Mounjaro (tirzepatida) for type 2 diabetes Registro de medicamento novo, Eli Lilly98 First dual GIP/GLP-1 agonist registered in Brazil, weekly injection for glycemic control in type 2 diabetes. Commercial availability only started in May 2025 after CMED pricing, at 2,5 mg and 5 mg.
ANVISA bans compounded hormone implants for aesthetic, muscle-gain and sports-performance purposes, and issues a health alert Resolucao-RE n 3.915, de 18/10/2024, and Alerta GGMON n 04/2024114 Prohibits compounding, sale and use of implantable hormone preparations based on steroids, anabolic steroids or androgenic hormones for those purposes, across all compounding pharmacies. Substances named include gestrinona, testosterona and oxandrolona. ANVISA
ANVISA registers Awiqli (insulina icodeca), first weekly insulin in the world Registro de produto biologico novo, Novo Nordisk Farmaceutica do Brasil Ltda. DOU de 05/03/2025, registro de 07/03/2025106 Weekly basal insulin approved in Brazil for diabetes mellitus in adults, covering both type 1 and type 2 per the ONWARDS programme. ANVISA approved it about 12.6 months before the FDA, which had issued a Complete Response Letter in July 2024 and ultimately app
ANVISA puts GLP-1 agonists under prescription-retention control Resolucao RDC n 973/2025 (amending RDC 471/2021) and Instrucao Normativa n 360/2025, both published in the DOU n 77 of 24/04/2025; in force 60 days later, from 2025-06-24, with 180 days for labelling changes115 Medicines based on semaglutida, liraglutida, dulaglutida, tirzepatida and lixisenatida, alone or in combination, now require a prescription in two copies, valid 90 days, with one copy retained by the pharmacy, following the antimicrobial model. Movements must
ANVISA extends Mounjaro (tirzepatida) to chronic weight management Ampliacao de indicacao terapeutica, publicada em 09/06/2025100 Adds weight loss and weight maintenance in adults with BMI at or above 30 kg/m2, or at or above 27 kg/m2 with at least one weight-related comorbidity. The manufacturer has 180 days to update labels. This is the Brazilian equivalent of the US Zepbound indicatio
Nota Tecnica 200/2025 effectively bans compounded semaglutida and tightens tirzepatida compounding Nota Tecnica n 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA, created 25/08/2025, published with Despacho 97/2025116 Compounding pharmacies may only use GLP-1 active ingredients whose use is proven in a medicine already registered by ANVISA. Biotechnology-derived ingredients may only be imported from the same manufacturer registered in Brazil, and synthetic semaglutida could
ANVISA registers Ozivy, the first synthetic semaglutide pen made in Brazil Registro de medicamento novo, EMS118 Weekly synthetic semaglutide pen for type 2 diabetes in adults, explicitly not a generic and not a biological generic, since it is produced by chemical synthesis rather than biotechnology. Its existence is what unlocked synthetic semaglutide supply in Brazil,
ANVISA alert: injectable research peptides sold online are irregular in Brazil Comunicado de esclarecimento, Checamos series119 States that BPC-157, TB-500, GHK-Cu, CJC-1295 and ipamorelina are not registered with ANVISA in any category. They are not medicines, since medicines require detailed clinical evidence of safety and efficacy; they are not dietary supplements, since no suppleme
ANVISA registers five more synthetic semaglutide pens Registros de medicamento novo121 Owozy (Avita Care), Seemasun (Sun Farmaceutica), Zempneo (Brainfarma), Semavy (Cosmed) and Orsema (Ranbaxy), all synthetic semaglutide for insufficiently controlled type 2 diabetes, registered by comparison with the biological Ozempic plus clinical evaluation
ANVISA registers the first liraglutide generics Registros publicados no DOU de 08/09/2026, EMS122 Olire for obesity and Lirux for type 2 diabetes, generics of Saxenda and Victoza, with registrations valid to 2036.
The one date that matters most for research peptides. There is no ANVISA resolution scheduling BPC-157, TB-500, GHK-Cu, CJC-1295 or ipamorelin. The agency's position is the 2 July 2026 alert: unregularized as medicine, supplement or cosmetic; no injectable supplement or cosmetic exists in Brazil; "research use only" does not authorize sale. Enforcement runs through seizure, prescription control (RDC 973/2025) and public communication, not scheduling.
07How ANVISA behaves after the FDA
For 14 peptide and biologic drugs we paired the FDA approval date with the ANVISA registration date. Eleven pairs are computable; the median lag is 11.4 months, 12.8 months for the GLP-1 subset alone.
Months from FDA approval to ANVISA registration. Negative = ANVISA first. Pegvaliase (67 months) is the outlier; insulin icodec is the counterexample where ANVISA led by 12.6 months with a broader label.
On GLP-1 receptor agonists ANVISA has followed the FDA on every first approval, and the lag has grown with the commercial stakes. Diabetes indications came 8,0 months (Ozempic) and 16,4 months (Mounjaro) after the FDA; obesity indications came 14,2 months (Saxenda), 19,4 months (Wegovy) and 19,0 months (Mounjaro for weight) after the US decision. The median lag across the 11 dated pairs in this sample is 11,4 months, 12,8 months for the GLP-1 subset.
The lag is structural, not specific to metabolic drugs. The largest published series on the question found a median 558-day gap between ANVISA and FDA approval dates for new solid-tumor drugs from 2008 to 2023, with ANVISA reviewing for 403 days against 224 at the FDA, and only 68 of 104 drugs reaching Brazilian approval at all. 123
ANVISA is not uniformly behind the FDA. It registered Awiqli, the first weekly basal insulin, on 7 March 2025 for both type 1 and type 2 diabetes, while the FDA had issued a Complete Response Letter in July 2024 over manufacturing and the type 1 indication and only approved the product on 26 March 2026, for type 2 alone. ANVISA led by about 12,6 months and with a broader label. 106
On compounding enforcement ANVISA followed the FDA by roughly four to six months and then diverged on substance. The FDA ended enforcement discretion for compounded tirzepatide on 19 February 2025 for 503A pharmacies and 19 March 2025 for 503B facilities, and for semaglutide on 22 April and 22 May 2025. ANVISA acted on 25 August 2025 through Nota Tecnica 200/2025 and Despacho 97/2025, which blocked compounded semaglutida by tying it to a registered product but kept tirzepatida compounding legal under stricter import and quality-control conditions, the opposite of the US ordering. 124
On falsified product alerts ANVISA acts on its own surveillance signal rather than waiting for a foreign or multilateral decision. It issued Resolucao-RE 3.945/2023 seizing the falsified Ozempic lot LP6F832 in November 2023, about seven months before the WHO global Medical Product Alert 2/2024 of 19 June 2024, and repeated the pattern unprompted for the falsified Mounjaro lot D881474 on 30 July 2026 and for unidentified-origin pens in May 2026. 125
For unregistered research peptides and compounded hormone products ANVISA reaches for communication, seizure and prescription control rather than new substance scheduling. The 2 July 2026 alert declared BPC-157, TB-500, GHK-Cu, CJC-1295 and ipamorelina unregularized as medicine, supplement and cosmetic, noting that no supplement may be injectable and that no injectable cosmetics exist, and that research-use-only labelling does not permit human sale. None of them was added to a Portaria 344/1998 list. The same toolkit appears in RE 3.915/2024 and RE 4.353/2024 on compounded hormone implants and in RDC 973/2025 with IN 360/2025, which imposed two-copy prescriptions with retention and SNGPC bookkeeping on five GLP-1 agonists from 24 June 2025, a domestic measure with no FDA analogue. 119
Published analyses
For new oncologic drugs for solid tumors approved 2008-2023, the median difference in approval dates was 558 days (IQR 278-957) between ANVISA and the FDA, and 435 days between ANVISA and the EMA. Median time to approval after submission was 224 days at the FDA (IQR 167-285), 364 at the EMA (330-418) and 403 at ANVISA (276-636). Of 104 drugs, 98 were approved by the FDA, 90 by the EMA and 68 by ANVISA. 123
From 2019 to 2024 the FDA approved 199 new solid tumor indications; 69.3 percent were also approved by the EMA and 62.3 percent by ANVISA. 126
ANVISA average total registration times for processes filed from April 2017 onward: 188 days for generics and similars, 276 days for new medicines and 356 days for innovative medicines. In 2015 the same figures were 997, 512 and 528 days, showing the internal review has sped up even while the gap to the FDA persists. 127
Interfarma research with 38 member companies found 20 post-registration safety and efficacy approvals where ANVISA decided before the EMA and the FDA. A 2020 comparison cited in the same coverage put average approval time at 305 days for ANVISA, 240 for the FDA and 388 for the EMA. Separately, the interval between technology incorporation and effective patient access in Brazil averages 37 months against a six-month legal deadline. 128
08FDA vs ANVISA today
Topic
United States (FDA)
Brazil (ANVISA)
Legal frame for compounding
FDCA 503A (patient-specific, state pharmacies) and 503B (outsourcing facilities); bulk substances must be on an approved list, the component of an approved drug, or USP-monographed.
RDC 67/2007 good compounding practices; substance-level control via Portaria 344/1998 lists; GLP-1s under prescription retention since RDC 973/2025.
Compounded semaglutide
Shortage declared over 21 Feb 2025; 503A cutoff 22 Apr 2025, 503B 22 May 2025; Fifth Circuit affirmed for FDA on 27 Aug 2026; proposed exclusion from the 503B bulks list pending.
Effectively banned by Nota Técnica 200/2025 (25 Aug 2025) until a synthetic-API product was registered; Ozivy registered 26 May 2026, five more pens 29 Jul 2026.
Compounded tirzepatide
Enforcement discretion ended first (Feb–Mar 2025), before semaglutide.
Still permitted for synthetic API under stricter import and quality rules, the reverse of the US order.
Retatrutide
Investigational; FDA told state boards on 31 Mar 2025 it may not be compounded under 503A or 503B.
Unapproved; Lilly signals a Q1 2027 filing; 7,834 retatrutide units seized in H1 2026.
BPC-157, TB-500, MOTS-c, Semax, Epithalon
Off every FDA list since April 2026 after nominators withdrew; still not compoundable; PCAC recommended all five for the 503A list in July 2026, FDA decision expected 2027.
Not scheduled; declared irregular in every category by the 2 July 2026 alert; no company has applied to regularize any of them.
Research-use-only sales to consumers
Unapproved new drug; warning letters (Swiss Chems Dec 2024, Wholesale Peptide Jun 2026, five letters Aug 2026), a 70-month prison sentence (Paradigm Peptides, Jul 2026), CBP parcel seizures.
Irregular; seizure orders, ANVISA inspections (8 companies interdicted in 2026), police operations against social-media sellers.
Imports of GLP-1 API
Import Alert 66-80: detention without physical examination unless the maker is on the Green List.
130 kg imported for compounding in H2 2025, enough for about 25 million doses, per ANVISA.
Falsified product alerts
Consumer advisories; 30 then 25 warning letters to telehealth sellers in 2026.
Acts on its own surveillance: falsified Ozempic lots seized since 2023, falsified Mounjaro lot 30 Jul 2026.
09FDA and 503A compounding, compound by compound
The premise most articles still repeat, that BPC-157 and its peers sit in "Category 2, significant safety risk", is out of date. On 29 September 2023 the FDA placed 19 substances (18 peptides plus ibutamoren) in 503A Category 2. In 2025 and 2026 the nominators withdrew those nominations and the FDA removed the substances from Category 2, twelve of them effective on or about 22 April 2026, expressly because the nominations were withdrawn, not on a new safety finding. Removal does not make them compoundable: they were never in Category 1, so today they satisfy none of the three statutory bases in 503A(b)(1)(A). Then, on 23–24 July 2026, the Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides for the bulks list, against the FDA staff position on every one. The recommendation is non-binding and no rulemaking has begun.
Compound
503A status, 11 Sep 2026
PCAC vote, Jul 2026
Detail
BPC-157
Category 1
8-6 with 1 abstention
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. Not in Category 1. PCAC voted to recommend inclusion on the 503A bulks list, but rulemaking has not begun, so compoundi… 129130131
TB-500
Off all lists
8-6 with 1 abstention
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. PCAC recommended inclusion; no rulemaking. Compounding remains unlawful as of 2026-09-11. 129130132
MOTS-c
Off all lists
7-5 with 2 abstentions
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. PCAC recommended inclusion; no rulemaking. Compounding remains unlawful as of 2026-09-11. 129130133
Semax
Off all lists
8-5
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. PCAC recommended inclusion; no rulemaking. Compounding remains unlawful as of 2026-09-11. 129130134
Epitalon
Off all lists
7-5 with 1 abstention
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. PCAC recommended inclusion; no rulemaking. Compounding remains unlawful as of 2026-09-11. 129130134
GHK-Cu
Category 1
scheduled
SPLIT BY ROUTE, and the only compound in this set whose status visibly changed twice in 2026. Non-injectable routes: CATEGORY 1 ('GHK-Cu (except for injectable routes of administration)'), being added back after a partia… 131129130
Kisspeptin-10
Category 2
none
503A CATEGORY 2 - UNCHANGED SINCE 2023. The only peptide from the September 2023 batch still in Category 2. FDA would consider enforcement action against a compounder using it. 129131130
Melanotan II
Off all lists
scheduled
On no FDA list. Nomination withdrawn, removed from 503A Category 2 effective on or about 2026-04-22. PCAC consultation committed before end of February 2027. Compounding unlawful as of 2026-09-11. 129130135
Ipamorelin
Category 2
none
SPLIT STATUS. For 503A: on no list; nomination withdrawn, removed from 503A Category 2; compounding unlawful. For 503B: STILL IN 503B CATEGORY 2, unchanged since 2023. Not scheduled for any PCAC meeting. 129136131
CJC-1295
Off all lists
none
On no FDA list. Nomination withdrawn, removed from 503A Category 2. NOT scheduled for any PCAC meeting. Compounding unlawful as of 2026-09-11, with no pathway in motion. 129130131
Selank
Off all lists
none
On no FDA list. Nomination withdrawn, removed from 503A Category 2. NOT scheduled for any PCAC meeting. Compounding unlawful as of 2026-09-11, with no pathway in motion. 129130131
AOD-9604
Off all lists
none
On no FDA list. Nomination withdrawn, removed from 503A Category 2. NOT scheduled for any PCAC meeting. Compounding unlawful as of 2026-09-11, with no pathway in motion. 129130131
Thymosin alpha-1
Off all lists
none
On no FDA list. Nomination withdrawn, removed from 503A Category 2. NOT scheduled for any PCAC meeting. Compounding unlawful as of 2026-09-11, with no pathway in motion. 129130131
Sermorelin
Category 1
none
NOT on any 503A interim category list - not Category 1, not Category 2, not Category 3 - and never placed in Category 2 in 2023. Sermorelin is widely compounded in practice and is reported to meet one of the three statut… 131129137
Tesamorelin
Never listed
none
NOT on any 503A interim category list and never was. Tesamorelin is the active ingredient of an FDA-approved drug (Egrifta), so as a bulk substance it can satisfy 503A(b)(1)(A)(ii) as a component of an approved drug. Sel… 131138139
PT-141
Never listed
none
NOT on any 503A interim category list, and never was. Bremelanotide is the active ingredient of an FDA-APPROVED drug (Vyleesi), which is a different legal situation from every withdrawn-nomination peptide above: a bulk s… 131129138
NAD+
Category 1
none
503A CATEGORY 1 - the most permissive status of any substance in this study. FDA lists 'Nicotinamide Adenine Dinucleotide (NAD)' and separately 'Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)' in Category 1. F… 131140137
Retatrutide
Never listed
none
NOT on any FDA list and categorically ineligible. Retatrutide is an investigational drug with no FDA approval, no USP monograph and no place on either bulks list. FDA has told state regulators in terms that it may not be… 141142143
The framework in nine points
FDCA section 503A (21 U.S.C. 353a) exempts drugs compounded by a state-licensed pharmacist or physician for an identified individual patient from new-drug approval, adequate-directions labeling and cGMP, if conditions are met. A bulk drug substance may be used only if it (i) complies with a USP or NF monograph and the applicable USP compounding chapter, (ii) is a component of an FDA-approved drug, or (iii) appears on 199
FDCA section 503B covers outsourcing facilities, which register with FDA, are subject to cGMP and FDA inspection, and may compound without patient-specific prescriptions. A 503B facility may use a bulk drug substance only if it appears on FDA's 503B clinical-need list or is on FDA's drug shortage list. 503A and 503B therefore have SEPARATE bulks lists and separate interim category lists. 200
The official 503A bulks list is codified at 21 CFR 216.23 and can only be changed by notice-and-comment rulemaking. FDA solicited nominations in 2015 (docket FDA-2015-N-3534, 80 FR, Oct 27 2015); a final rule in February 2019 placed six substances on the list and rejected four; a September 2019 proposal would add five and reject twenty-six. 140
While that rulemaking is pending, FDA operates an INTERIM enforcement policy that sorts nominated substances into three categories. FDA's own heading wording: 'Category 1: Bulk Drug Substances Under Evaluation'; 'Category 2: Bulk Drug Substances that Raise Significant Safety Concerns'; 'Category 3: Bulk Drug Substances Nominated Without Adequate Support'. On the list pages the Category 2 heading reads '503A Category 202
Category 1 meaning: nominated with sufficient supporting information for FDA to evaluate, may be eligible for inclusion on the 503A bulks list, and does not appear on any other list. FDA does not intend to take action against a compounder for compounding with a Category 1 substance provided the other 503A conditions are met. Category 1 is the only category under which compounding is practically tolerated pending rule 140
Category 2 meaning for a 503A pharmacy: FDA's page states 'Bulk drug substances that may present significant safety risks have been placed in category 2 under the interim policies.' Per FDA's interim guidance, FDA has identified significant safety risks pending further evaluation, does not extend the Category 1 enforcement posture to these substances, and would consider taking action against a compounder who uses the 203
Category 3 meaning: nominated with insufficient supporting information for FDA to evaluate. Requires re-nomination, gets no Category 1 protection, and FDA may pursue enforcement. Ohio's Board of Pharmacy treats Category 2 AND Category 3 as non-compoundable. 140
CRITICAL LEGAL POINT, frequently misreported: removal from Category 2 does not authorise compounding. None of the 2023 peptides was ever in Category 1. Removal leaves them on no list at all, so they satisfy none of the three statutory bases in 503A(b)(1)(A) and remain unlawful to compound. Frier Levitt: 'Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A.' T 205
The Pharmacy Compounding Advisory Committee (PCAC) is the federal advisory committee FDA must consult before adding a substance to the 503A bulks list. Its recommendations are NON-BINDING. After a favourable PCAC vote FDA must still accept the recommendation and complete notice-and-comment rulemaking, which can take more than a year. FDA renewed the PCAC charter on 2026-04-30. 183
GLP-1 compounding, 2025–2026
FDA declared the SEMAGLUTIDE shortage resolved for all doses of Ozempic and Wegovy by Declaratory Order. Transition periods: 503A until 2025-04-22, 503B until 2025-05-22. 144
OFA filed its second suit, over semaglutide: No. 4:25-cv-00174 (N.D. Tex., Judge Pittman). The complaint alleged FDA's no-shortage finding was arbitrary and capricious and cited roughly 2 million US patients on compounded semaglutide between November 2023 and November 2024 against Novo's 1.2 million Wegovy patients. 145
FDA letters to NABP and FSMB (from Edisa Gozun, PharmD, Division of Compounding II) stating that compounding with retatrutide is prohibited under both 503A and 503B. Relayed to all state board executive officers by NABP memo on 2025-04-03. This is the bridge between the GLP-1 story and the research-peptide story. 141
Judge Pittman DENIED OFA's preliminary injunction and its request for a stay in the tirzepatide case; the order was entered under seal. OFA filed an interlocutory appeal 2025-03-10 (5th Cir. No. 25-10385, docketed 2025-03-13), then voluntarily dismissed it (terminated 2025-05-02) once final judgment was entered. 147
Court DENIED OFA's preliminary injunction in the semaglutide case. 149
Eli Lilly filed four suits in N.D. Cal. against Mochi Health, Fella Health (Fella & Delilah), Willow Health Services and Henry Meds, alleging deceptive marketing of mass-produced compounded tirzepatide as 'personalized' and improper corporate practice of medicine. Mochi was alleged to have switched patients to tirzepatide plus n… 150
FDA publicly reiterated that 503A enforcement discretion for compounded semaglutide had expired. 151
Judge Pittman ruled for FDA on the merits in the semaglutide case and DISMISSED WITH PREJUDICE. OFA appealed; the appeal was docketed at the Fifth Circuit as No. 25-10758 on 2025-06-20. Final judgment for FDA in the tirzepatide case produced 5th Cir. No. 25-10600, docketed 2025-05-12 (district-court final-judgment date UNVERIFIE… 152
38 bipartisan state and territory attorneys general, co-led by South Carolina, Colorado, Illinois and Tennessee, urged FDA to act against illegally sold GLP-1 active ingredients: 'online retailers are illegally selling the active ingredients of GLP-1 drugs directly to consumers, without a prescription. These retailers claim that… 154
FDA launched a GLP-1 API 'Green List' and established Import Alert 66-80: GLP-1 APIs from facilities FDA has inspected and found compliant are exempt, and all other GLP-1 APIs are subject to detention without physical examination. FDA had inspected or remotely assessed 48 GLP-1 API manufacturing sites and deemed 21% noncompliant… 155
FDA issued warning letters to JulyMD and GLP-1 Solution, signed by CDER Director George Tidmarsh, over compounded GLP-1 claims. Days later FDA issued its first mass wave of warning letters to online sellers and telehealth marketers of compounded GLP-1s on 2025-09-16. The count of that wave is DISPUTED across sources ('more than … 156
Trump administration announced deals with Eli Lilly and Novo Nordisk to cut obesity-drug prices, including a TrumpRx.gov platform launching January 2026, with starting doses of Wegovy and Zepbound at $350/month trending to $245/month over two years. Novo then cut NovoCare direct-to-consumer cash prices for Wegovy and Ozempic to … 158
Novo launched oral Wegovy (semaglutide pill) at $149/month self-pay. Hims & Hers launched a compounded ORAL semaglutide product priced against it on 2026-02-05. 161
FDA press release 'FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs', naming Hims & Hers, saying FDA will use 'all available compliance and enforcement tools' explicitly including seizure and injunction, and listing prohibited claims such as calling compounded products generic or equivalent, 'same active ingredien… 162
HHS General Counsel Mike Stuart announced a referral of Hims & Hers to DOJ for potential FDCA and Title 18 violations. Hims & Hers said it would stop offering the compounded oral semaglutide pill on 2026-02-07. Novo Nordisk sued Hims & Hers in D. Del. on 2026-02-09 over U.S. Patent No. 8,129,343; HIMS fell about 18%. 163
FDA issued 30 warning letters to telehealth companies (sent 2026-02-20, published 2026-03-03) over false and misleading compounded GLP-1 claims. Two cited violations were new: implying sameness with FDA-approved products, and obscuring sourcing by branding the compounded drug with the telehealth firm's own name or trademark so i… 165
Novo dismissed its Hims & Hers suit as part of a commercial deal: Hims will sell branded oral and injectable Wegovy and Ozempic and stop advertising compounded GLP-1s, with Novo reserving the right to refile. HIMS shares rose about 36%. 166
FDA updated its GLP-1 compounding policy page, clarifying the 503A(b) 'essentially a copy' test: same API, same or similar or easily substitutable strength, same route of administration, with an exception only where a prescriber determines and documents a change producing a 'significant difference' for an identified individual p… 124
Judge Jacqueline Scott Corley (N.D. Cal.) partly denied Mochi's motion to dismiss in Eli Lilly v. Mochi Health Corp., No. 3:25-cv-03534, letting Lilly proceed on Lanham Act and California Unfair Competition Law claims while dismissing the civil conspiracy claim with leave to amend (second amended complaint due 2026-05-08). 169
FDA PROPOSED TO EXCLUDE semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need. This would close the remaining large-scale outsourcing-facility pathway. Commissioner Marty Makary: 'When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substance… 171
M.D. Fla. dismissed Novo Nordisk v. Brooksville Pharmaceuticals for failure to show consumer injury under the Florida Drug and Cosmetic Act - one of the few compounder wins. Exact date UNVERIFIED (reported as May 2026). 173
FDA warning letter to Altru Telehealth, LLC (Oakland, MD) over compounded semaglutide and tirzepatide claims, including that it 'combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12', that it 'offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & … 174
Third wave: FDA published 25 warning letters to telehealth and compounding companies over compounded semaglutide, tirzepatide and, in one case, liraglutide marketing. FDA's guidance page 'FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs', listing five prohibited marketing practices, was last updated 2026… 175
FDA published 17 revised draft product-specific guidances for generic peptide products and withdrew its prior synthetic-peptide ANDA guidance as no longer reflecting 'FDA's current scientific thinking'. This matters for the compounding fight because it is FDA signalling a preference for approved generic peptides over compounded … 177
Import Alert 66-80 revised, with product codes for semaglutide (61P[][]72), tirzepatide (61P[][]74) and peptides N.E.C., plus an updated Green List. This is the current version as of 2026-09-11. 178
THE FIFTH CIRCUIT AFFIRMED FOR FDA IN BOTH APPEALS - semaglutide No. 25-10758 and tirzepatide No. 25-10600 - holding FDA 'followed the statutory framework, applying the statutory definition of shortage to the evidence before it.' CourtListener shows 25-10600 terminated 2026-08-27. CAVEAT: the opinion PDF at ca5.uscourts.gov woul… 179
WHERE THINGS STAND 2026-09-11. No new GLP-1 shortage: semaglutide and tirzepatide injection remain off FDA's shortage list (removed December 2024 and February 2025) and have not been re-listed. Compounded semaglutide and tirzepatide are still widely sold, but the only lawful 503A basis left is genuinely patient-specific compound… 124
NEGATIVE FINDING worth recording: no FTC enforcement action, consent order or warning-letter campaign specifically targeting compounded GLP-1 sellers in 2025-2026 was found. The advertising enforcement documented here is FDA and HHS, plus the DOJ referral - not FTC. Also UNVERIFIED: FDA's 2026-02-06 announcement threatens seizur…
10What happens next
before 2027-02-28 — PCAC meeting on the remaining five peptides from the 2023 batch: GHK-Cu, Melanotan II, Cathelicidin LL-37, Dihexa acetate and PEG-MGF. FDA has committed to consult PCAC before the end of February 2027. No Federal Register meeting notice has been published yet, Not yet assigned. FDA's commitment is recorded in its own 503A list documen131
Expected 2027; no date announced as of 2026-09-11 — FDA's decision whether to accept the July 2026 PCAC recommendations for BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon, and then open notice-and-comment rulemaking to add them to 21 CFR 216.23. FDA review staff recommended AGAINST all of them, so acceptance FDA-2025-N-6895 is the PCAC meeting docket (closed 2026-07-22, approximately 1,8184
Pending as of 2026-09-11; no final determination published — FDA's final determination on excluding semaglutide, tirzepatide and liraglutide from the 503B clinical-need bulks list. Comment period closed in mid-2026 after an extension. This is the most consequential pending compounding decision of late 2026 and would end Federal Register documents 2026-08552 (published 2026-05-01) and 2026-12937 (ext172
Watch late 2026 — Any petition for rehearing en banc or certiorari in the Fifth Circuit GLP-1 shortage appeals (Nos. 25-10758 and 25-10600, affirmed for FDA 2026-08-27). None located as of 2026-09-11. A certiorari deadline would fall in late 2026, making this a live item to wat 5th Cir. Nos. 25-10758 (semaglutide) and 25-10600 (tirzepatide); district cases 188
Status unknown as of 2026-09-11 — Evexias Medical Centers, PLLC et al. v. FDA (with FarmaKeio), the Administrative Procedure Act challenge in Texas to the Category 2 placements of AOD-9604, CJC-1295, Ipamorelin acetate and Thymosin Alpha-1. Three of the four placements have since been vacated UNVERIFIED - no case number located183
2027-01-01 registration deadline — Indiana med-spa registration deadline under SB 282 (Ind. Code 25-22.5-12.5): med spas providing weight-loss, wellness, longevity or aesthetic services using prescription drugs or injectables must register with the Medical Licensing Board by 2027-01-01, with 15 Indiana SB 282 (2026), signed 2026-03-05189
Pending in the 119th Congress as of 2026-09-11 — Federal compounding bills pending in the 119th Congress that would tighten rather than loosen compounding: H.R.6509 'SAFE Drugs Act of 2025' (Reps. Rudy Yakym and Andre Carson) and its Senate companion S.3794 'SAFE Drugs Act of 2026', which would cap essential H.R.6509; S.3794; H.R.5316190
Ongoing through late 2026 and the 2027 state sessions — State-level divergence to watch. Louisiana Act 374 (La. R.S. 37:23.5), effective 2026-08-01, is the only enacted peptide-specific state law: it bars licensing boards from prohibiting providers from supplying peptides sourced from an FDA-registered 503B facilit La. SB 253 / Act 374; CA AB 2442; ALEC model policy73
Watch from 2026-08-19 onward — FDA leadership transition as a variable. Marty Makary resigned as FDA Commissioner on 2026-05-13; Heidi Overton was picked to lead FDA on 2026-08-19. No peptide statement from Overton has been found. The April and July 2026 peptide actions happened under Makar Not applicable197
Applying the median lag from section 7 to the FDA timeline gives a rough expectation for Brazil: if the FDA accepts the July 2026 recommendations during 2027, the earliest an ANVISA reaction on the same substances would be expected is 2028, and the historical pattern suggests it would arrive as communication and control measures before any positive listing.
11Methodology and limits
Prices were read from vendor pages on 10–11 September 2026 and converted to price per mg. Where a vendor did not sell the exact size, the closest size was recorded and is visible in the source row. Two Brazilian catalogues render client-side, so their price sets are samples rather than full sweeps.
Certificates were assessed from what the vendor publishes before purchase: purity claim, whether a laboratory is named, and whether a document matching a lot number is downloadable. No vials were tested for this report.
Vendor selection used visibility in independent comparison articles and community sources; there is no audited traffic data for this channel. Axion's first position is assigned by the publisher.
Regulatory dates come from official gazettes, agency pages, court dockets and, where those were offline, from professional councils and Agência Brasil; three ANVISA dates are recorded at month precision and one (Wegovy) has two conflicting sources, both shown.
Enforcement figures are labelled by type. The FDA publishes no aggregate peptide import-refusal count, so the interception rate comes from congressional testimony. Three lower-confidence figures were excluded from the tables.
Gaps found on the publisher's own pages during research: axionresearchpeptides.com publishes its certificate on request rather than per lot and names no laboratory; its BPC-157 and TB-500 pages state 10 mg in the title and 5 mg in the specification table. axionbiolab.com names Frontage Laboratories and publishes lot-matched PDFs for BPC-157 and GHK-Cu, but not yet for every SKU. These are recorded here so the reader can judge the vendor tables with the same rule applied to everyone.
Research use only. Nothing in this report is medical advice, and none of the compounds discussed is approved for human use in either country outside the specific approved products named.