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Regulator: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios, Secretaría de Salud)

GLP-1 drugs and peptides in Mexico

In Mexico, a federal health agency called COFEPRIS decides which medicines can be sold. Semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro), liraglutide and dulaglutide are registered and need a doctor's prescription. Some companies have applied to sell generic semaglutide, but none was on COFEPRIS's list of new registrations as of August 2026. Peptides sold online as 'research' products have no registration in Mexico, and a member of Congress has proposed a ban on selling them.

Last verified 2026-09-29 · how we verify

Official regulator site

GLP-1 medicines

Registrations in COFEPRIS lists: Ozempic (2019), Rybelsus (2021) and Wegovy (2023) for semaglutide; Victoza (2009), Saxenda (2015) and Xultophy (2018) for liraglutide; Trulicity (2015) for dulaglutide; Mounjaro (November 2024) for tirzepatide; and Foundayz, orforglipron tablets (July 2026). Novo Nordisk México announced the Wegovy launch for April 2025 and COFEPRIS's reference list gives Saxenda's weight-management indication. Press reports say a higher-strength Wegovy injection and a liver-disease indication were approved in July 2026 and a Wegovy tablet in August 2026; we did not find COFEPRIS's own record of those. COFEPRIS's 2026 list of innovator applications does show a Novo Nordisk México application for semaglutide tablets filed on 30 April 2026. Bydureon (exenatide) was cancelled in 2025. We found no generic or biocomparable GLP-1 in the published registration lists, but the 2026 applications list has six generic semaglutide and seven generic or biocomparable liraglutide entries. COFEPRIS also alerts on counterfeit and unregistered GLP-1 products sold through e-commerce and informal channels, including counterfeit Ozempic lots in June 2025, March 2026 and May 2026.

Peptides

No unapproved peptide from the tracked list (BPC-157, TB-500, GHK-Cu, CJC-1295, ipamorelin, Melanotan 2, epitalon and others) has a COFEPRIS registration, so none can lawfully be marketed as a medicine. A bill introduced in July 2026 by the Movimiento Ciudadano coordinator would add Article 215 Bis to the Ley General de Salud, banning the sale of 'research peptides' without registration and asking COFEPRIS to publish a list by official standard; it is only a proposal, and we found no record that Congress has approved it. The bill's authors argue that the law currently has no provision that classifies such compounds or expressly bans selling them, and that COFEPRIS has so far alerted only on illegal online tirzepatide. Separately, COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. We found no COFEPRIS alert naming BPC-157 or retatrutide on the alerts pages we could read. On sport, the bill says WADA lists several of these peptides, especially growth-factor related ones, as prohibited for competitors; we did not verify individual substances. We did not find specific compounding or importation rules for peptides.

Advertising rules

COFEPRIS runs a permit procedure for advertising health products, services and supplies (COFEPRIS-02-001). We could not retrieve the text of the Ley General de Salud or its advertising regulation, so we make no claim here about which medicines may be advertised to the public or only to health professionals. We found no COFEPRIS guidance specific to weight-loss drug advertising.

Every molecule in Mexico

MoleculeStatusWhat it meansVerified
AmycretinNot approvedNot registered in Mexico; amycretin is an investigational Novo Nordisk medicineDetails →source2026-09-29
AOD-9604Not approvedNo registration for AOD-9604 found in COFEPRIS listsDetails →source2026-09-29
BPC-157Not approvedNot approved in Mexico; a 2026 bill would expressly ban sale of unregistered research peptidesDetails →source2026-09-29
Bremelanotide (PT-141)Not approvedNo registration for bremelanotide found in COFEPRIS listsDetails →source2026-09-29
Cagrilintide (and CagriSema)Not approvedNot registered in Mexico; CagriSema and cagrilintide are still investigational thereDetails →source2026-09-29
CJC-1295Not approvedNot approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-checkDetails →source2026-09-29
DSIP (delta sleep-inducing peptide)Not approvedNo registration for DSIP found in COFEPRIS listsDetails →source2026-09-29
DulaglutideApprovedApproved as Trulicity (Eli Lilly) for type 2 diabetes; listed as valid by COFEPRIS in May 2024Details →source2026-09-29
EcnoglutideNot approvedNot registered in Mexico; ecnoglutide is approved only in ChinaDetails →source2026-09-29
Elamipretide (SS-31)Not approvedNo registration for elamipretide found in COFEPRIS listsDetails →source2026-09-29
EloralintideNot approvedNot registered in Mexico; eloralintide is an investigational Eli Lilly medicineDetails →source2026-09-29
EpitalonNot approvedNot approved in Mexico; unregistered peptide named in a July 2026 billDetails →source2026-09-29
ExenatideUnverifiedBydureon's registration was cancelled in 2025; the status of Byetta could not be confirmedsource2026-09-29
GHK-Cu (copper peptide)Not approvedNot approved as a medicine in Mexico; injectable copper peptide is unregisteredDetails →source2026-09-29
IpamorelinNot approvedNot approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-checkDetails →source2026-09-29
KisspeptinNot approvedNo registration for kisspeptin found in COFEPRIS listsDetails →source2026-09-29
KPVNot approvedNo registration for KPV found in COFEPRIS listsDetails →source2026-09-29
LiraglutideApprovedApproved as Victoza (diabetes), Saxenda (weight) and Xultophy; several generic and biocomparable applications pendingDetails →source2026-09-29
LL-37Not approvedNo registration for LL-37 found in COFEPRIS listsDetails →source2026-09-29
Maridebart cafraglutide (MariTide)Not approvedNot registered in Mexico; MariTide is an investigational Amgen medicineDetails →source2026-09-29
MazdutideNot approvedNot registered in Mexico; mazdutide is approved only in ChinaDetails →source2026-09-29
Melanotan IINot approvedNot approved in Mexico; unregistered tanning peptide named in a July 2026 bill and a fact-checkDetails →source2026-09-29
MOTS-cNot approvedNo registration for MOTS-c found in COFEPRIS listsDetails →source2026-09-29
NAD+Not approvedNo registration for NAD+ as an injectable medicine found in COFEPRIS listsDetails →source2026-09-29
OrforglipronApprovedRegistered by COFEPRIS in July 2026 as Foundayz (Eli Lilly); the register does not state the indicationDetails →source2026-09-29
PramlintideNot approvedNo registration for pramlintide found in COFEPRIS listsDetails →source2026-09-29
RetatrutideNot approvedNot registered in Mexico; retatrutide is unapproved everywhereDetails →source2026-09-29
SelankNot approvedNo registration for selank found in COFEPRIS listsDetails →source2026-09-29
SemaglutideApprovedApproved in Mexico as Ozempic, Rybelsus and Wegovy; generic applications are pending but none is registeredDetails →source2026-09-29
SemaxNot approvedNo registration for semax found in COFEPRIS lists; approved only in RussiaDetails →source2026-09-29
SermorelinNot approvedNo current registration for sermorelin found in COFEPRIS listsDetails →source2026-09-29
SetmelanotideNot approvedNo registration for setmelanotide found in COFEPRIS listsDetails →source2026-09-29
SurvodutideNot approvedNot registered in Mexico; survodutide is an investigational Boehringer Ingelheim medicineDetails →source2026-09-29
TB-500 (thymosin beta-4 fragment)Not approvedNot approved in Mexico; unregistered peptide named in a July 2026 billDetails →source2026-09-29
TesamorelinUnverifiedCOFEPRIS registered Egrifta (tesamorelin) in 2015; whether the registration is still valid could not be confirmedsource2026-09-29
TirzepatideApprovedApproved as Mounjaro (Eli Lilly), registered in 2024; COFEPRIS has warned about unregistered tirzepatide sold onlineDetails →source2026-09-29

For experts

The regulatory detail

Medicines need a sanitary registration (registro sanitario) from COFEPRIS before sale, and COFEPRIS's lists show most GLP-1 products in class IV of Article 226 of the Ley General de Salud, a class of medicines that need a prescription. COFEPRIS publishes yearly lists of registrations issued, cancelled and extended, and lists of applications received, including generic and biocomparable filings that open a ten-working-day window for patent opposition. New active ingredients already approved in the EU, Switzerland, the US, Canada or Australia can be filed under equivalence agreements; Lilly's tirzepatide was filed that way in April 2024. COFEPRIS and Brazil's ANVISA announced on 24 September 2026 that they are moving toward mutual recognition of regulatory opinions, after Mexico published guidelines on 2 September 2026 recognising ANVISA's requirements. As of 31 August 2026 the applications list has six generic semaglutide and seven generic or biocomparable liraglutide entries for 2026, and none appears in COFEPRIS's list of registrations issued in 2026 (updated 4 August 2026). Press reports say a court gave semaglutide ten years of clinical-data protection, which the generics association ANAFAM disputes. On compounding, we could not retrieve the current text of the rules on magistral formulas and found no COFEPRIS guidance on compounded GLP-1s, so we make no claim. On personal importation, COFEPRIS lists permit procedures for personal-use imports of medicines, but we could not read the eligibility rules. On coverage, we found no official statement on public reimbursement of GLP-1s for obesity; a COFEPRIS alert says liraglutide lots were destined for the public health sector, and one press report puts an Ozempic pen at about 4,500 to 6,500 pesos. On enforcement, COFEPRIS issued alerts on illegal tirzepatide (9 February 2026), counterfeit Victoza (19 February 2026), counterfeit Ozempic (17 June 2025, 26 March 2026 and 25 May 2026) and counterfeit Rybelsus (13 April 2026).

Official sources we monitor

Sources (41)

  1. 01COFEPRIS: portal oficial (registros, alertas, publicidad, importación)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-09-29 · accessed 2026-09-29
  2. 02Alertas sanitarias de medicamentos (índice)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-09-28 · accessed 2026-09-29
  3. 03Listados de registros sanitarios de medicamentos (visor y listas anuales)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2025-08-21 · accessed 2026-09-29
  4. 04Consulta de solicitudes ingresadas de registros sanitarios para medicamentos alopáticosCOFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2025-09-22 · accessed 2026-09-29
  5. 05Solicitudes de medicamentos genérico o biocomparable ingresadas en 2026COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-08-31 · accessed 2026-09-29
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  7. 07Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitarioCOFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-02-09 · accessed 2026-09-29
  8. 08Alerta sanitaria: falsificación de Victoza (liraglutida) solución inyectableCOFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-02-19 · accessed 2026-09-29
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  13. 13Importación de consumo personal (trámites y permisos)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-04-29 · accessed 2026-09-29
  14. 14Permisos sanitarios: trámites (incluye permiso de publicidad COFEPRIS-02-001)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-04-30 · accessed 2026-09-29
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  17. 17Novo Nordisk anuncia el lanzamiento de semaglutida en México a partir de abril de 2025 (comunicado de prensa)Novo Nordisk México · 2025-02-26 · accessed 2026-09-29
  18. 18Medicamentos biotecnológicos de referencia (versión 10)COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2024-05 · accessed 2026-09-29
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