GIP/GLP-1 receptor agonist

Tirzepatide companies

Answer

Public registers name 2 licence holders, 38 ingredient makers with a drug master file, 32 bulk ingredient labelers, 5 US labelers, 138 trial sponsors, 110 companies with an FDA warning letter and 6 recalling firms for Tirzepatide.

Each row is what a register states. A company named here is not endorsed or accused by this site.

MARKETING AUTHORISATION HOLDER

2 companies

Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).

ELI LILLY CANADA INC
MOUNJARO (DIN 02532891), Approved Regulator Health Canada
MOUNJARO (DIN 02532905), Approved Regulator Health Canada
MOUNJARO (DIN 02532913), Approved Regulator Health Canada
and 21 more entries
Eli Lilly Nederland B.V.
Mounjaro (EMEA/H/C/005620), Authorised Regulator EMA
MOUNJARO 10 MG KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN, PLGB 14895/0343, Authorised Regulator MHRA
MOUNJARO 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN, PLGB 14895/0321, Authorised Regulator MHRA
and 16 more entries

API MANUFACTURER

38 companies

Filed a drug master file with FDA for the active ingredient.

ALEMBIC PHARMACEUTICALS LTD
DMF 43203, type II, active, submitted 2026-02-25 Regulator FDA drug master file list
ALLSINO PHARMACEUTICAL CO LTD
DMF 42448, type II, active, submitted 2025-08-22 Regulator FDA drug master file list
DMF 42449, type II, active, submitted 2025-09-28 Regulator FDA drug master file list
ALP PHARM BEIJING CO LTD
DMF 38773, type II, active, submitted 2023-08-30 Regulator FDA drug master file list
APICORE US LLC
DMF 40123, type II, active, submitted 2024-07-27 Regulator FDA drug master file list
BIOCON LTD
DMF 43038, type II, active, submitted 2025-11-24 Regulator FDA drug master file list
CHANGZHOU PHARMACEUTICAL FACTORY
DMF 43153, type II, active, submitted 2025-11-28 Regulator FDA drug master file list
CHENGDU SHENGNUO BIOPHARM CO LTD
DMF 42445, type II, active, submitted 2025-11-26 Regulator FDA drug master file list
CHINESE PEPTIDE CO
DMF 43979, type II, active, submitted 2026-04-27 Regulator FDA drug master file list
DR REDDYS LABORATORIES LTD
DMF 43800, type II, active, submitted 2026-03-31 Regulator FDA drug master file list
EL-PEPTIDO (SHANGHAI) BIOPHARMACEUTICAL CO LTD
DMF 43426, type II, active, submitted 2025-12-29 Regulator FDA drug master file list
FUJIAN GENOHOPE BIOTECH LTD
DMF 40503, type II, active, submitted 2024-09-19 Regulator FDA drug master file list
GUIZHOU UTIDE BIOTECHNOLOGY CO LTD
DMF 42984, type II, active, submitted 2025-12-24 Regulator FDA drug master file list
HANGZHOU APEXTIDE BIOMEDICAL TECHNOLOGY CO LTD
DMF 40481, type II, active, submitted 2024-12-10 Regulator FDA drug master file list
HANGZHOU HOTIDE BIOTECH CO LTD
DMF 41744, type II, active, submitted 2025-10-31 Regulator FDA drug master file list
HANGZHOU THINHEAL PHARMA-TECH CO LTD
DMF 39900, type II, active, submitted 2024-06-28 Regulator FDA drug master file list
Harbin Jixianglong Biotech Co., Ltd.
DMF 39611, type II, active, submitted 2024-02-28 Regulator FDA drug master file list
HYBIO PHARMACEUTICAL CO LTD
DMF 40156, type II, active, submitted 2024-06-27 Regulator FDA drug master file list
JENKEM TECHNOLOGY CO LTD
DMF 40925, type II, active, submitted 2024-12-12 Regulator FDA drug master file list
MSN LIFE SCIENCES PRIVATE LTD
DMF 43540, type II, active, submitted 2026-02-11 Regulator FDA drug master file list
NANJING CELLNUO BIOPHARMACEUTICAL CO LTD
DMF 41650, type II, active, submitted 2025-03-28 Regulator FDA drug master file list
NANJING HANXIN PHARMACEUTICAL TECHNOLOGY CO LTD
DMF 40378, type II, active, submitted 2024-12-11 Regulator FDA drug master file list
NINGXIA LABSCHEM CO LTD
DMF 42259, type II, active, submitted 2025-07-03 Regulator FDA drug master file list
SHANGHAI JINGMAI PHARMACEUTICAL SCIENCE & TECHNOLOGY CO LTD
DMF 40166, type II, active, submitted 2024-06-27 Regulator FDA drug master file list
SHENZHEN ALVANTIS PHARMA CO LTD
DMF 40668, type II, active, submitted 2024-10-16 Regulator FDA drug master file list
SHENZHEN JYMED TECHNOLOGY CO LTD
DMF 40115, type II, active, submitted 2024-07-18 Regulator FDA drug master file list
SHENZHEN READLINE BIOTECH CO LTD
DMF 41461, type II, active, submitted 2025-03-16 Regulator FDA drug master file list
SICHUAN DUORUI BIOPHARMACEUTICAL CO LTD
DMF 43257, type II, active, submitted 2025-12-10 Regulator FDA drug master file list
SICHUAN JISHENG BIOPHARMACEUTICAL CO LTD
DMF 41523, type II, active, submitted 2025-03-19 Regulator FDA drug master file list
SICHUAN PUKANG PHARMACEUTICAL CO LTD
DMF 39989, type II, active, submitted 2024-06-28 Regulator FDA drug master file list
SICHUAN QISHENG BIOMEDICAL TECHNOLOGY CO LTD
DMF 40495, type II, active, submitted 2024-09-11 Regulator FDA drug master file list
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD
DMF 39465, type II, active, submitted 2024-02-06 Regulator FDA drug master file list
SUZHOU MOTIF BIOTECH CO LTD
DMF 41036, type II, active, submitted 2025-01-03 Regulator FDA drug master file list
SUZHOU RYWAY BIOTECH CO LTD
DMF 41066, type II, active, submitted 2024-12-25 Regulator FDA drug master file list
SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTD
DMF 44306, type II, active, submitted 2026-06-29 Regulator FDA drug master file list
TAPI NL BV
DMF 42369, type II, active, submitted 2025-12-15 Regulator FDA drug master file list
XIUSHI BIOPHARMA (NANTONG) CO LTD
DMF 43983, type II, active, submitted 2026-03-30 Regulator FDA drug master file list
YANGZHOU AURISCO PHARMACEUTICAL CO LTD
DMF 41816, type II, active, submitted 2025-12-31 Regulator FDA drug master file list
ZHEJIANG PEPTITES BIOTECH CO LTD
DMF 39655, type II, active, submitted 2024-03-17 Regulator FDA drug master file list
DMF 42981, type II, active, submitted 2025-11-23 Regulator FDA drug master file list

BULK INGREDIENT LABELER

32 companies

Lists the bulk active ingredient with FDA (NDC directory).

Apicore pharmaceuticals private limited
Tirzepatide, BULK INGREDIENT Regulator openFDA
Assia Chemical Industries Ltd - Teva Tech Site
Tirzepatide, BULK INGREDIENT Regulator openFDA
Aurisco Pharmaceutical Co.,Ltd
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Biocon Limited
TIRZEPATIDE, BULK INGREDIENT Regulator openFDA
BioVectra Inc.
Tirzepatide, BULK INGREDIENT Regulator openFDA
Chatnaa Life Sciences LLC
Tirzepatide, BULK INGREDIENT Regulator openFDA
CHENGDU SHENGNUO BIOPHARM CO LTD
tirzepatide, BULK INGREDIENT Regulator openFDA
CHONGQING SINTAHO PHARMACEUTICAL CO LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
CORDEN PHARMA COLORADO INC
Tirzepatide, BULK INGREDIENT Regulator openFDA
Darmerica, LLC
Tirzepatide, BULK INGREDIENT Regulator openFDA
EL-PEPTIDO (SHANGHAI) BIOPHARMACEUTICAL CO LTD
TIRZEPATIDE, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Eli Lilly & Company
tirzepatide, BULK INGREDIENT Regulator openFDA
FUJIAN GENOHOPE BIOTECH LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
Guangdong Longfu Medicine Co., Ltd.
TIRZEPATIDE, BULK INGREDIENT Regulator openFDA
HANGZHOU HOTIDE BIOTECH CO LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
Harbin Jixianglong Biotech Co., Ltd.
Tirzepatide, BULK INGREDIENT Regulator openFDA
Hubei JXBio Pharmaceutical Co.,Ltd
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
HYBIO PHARMACEUTICAL CO LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Medisca Inc.
Tirzepatide, BULK INGREDIENT Regulator openFDA
MSN Life Sciences Private Limited
Tirzepatide, BULK INGREDIENT Regulator openFDA
NOMIDA LLC
Tirzepatide, BULK INGREDIENT Regulator openFDA
Pharma Source Direct, Inc.
Tirzepatide, BULK INGREDIENT Regulator openFDA
Qingdao Biopeptek Co., Ltd.
Tirzepatide, BULK INGREDIENT Regulator openFDA
Shanghai SynTheAll Pharmaceutical Co., Ltd.
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
SHENZHEN ALVANTIS PHARMA CO LTD
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
SICHUAN JISHENG BIOPHARMACEUTICAL CO LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD
Tirzepatide, BULK INGREDIENT Regulator openFDA
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
SUZHOU LIXIN PHARMACEUTICAL CO LTD
tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Thaeta Scientific LLC
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Zhejiang Kingland Pharmaceutical Company Limited
tirzepatide, BULK INGREDIENT Regulator openFDA
ZHEJIANG PEPTITES BIOTECH CO LTD
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Zhejiang Tasln Biopharma Co., Ltd.
Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA

US LABELER

5 companies

Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.

A-S Medication Solutions
MOUNJARO, NDA Regulator openFDA
BSP Pharmaceuticals SpA
Multiple-Dose Tirzepatide Injection, DRUG FOR FURTHER PROCESSING Regulator openFDA
tirzepatide, DRUG FOR FURTHER PROCESSING Regulator openFDA
Eli Lilly & Company
Mounjaro KwikPen, NDA Regulator openFDA
Mounjaro, NDA Regulator openFDA
Zepbound KwikPen, NDA Regulator openFDA
and 2 more entries
Eli Lilly Italia SPA
tirzepatide, DRUG FOR FURTHER PROCESSING Regulator openFDA
Resilience US, LLC
tirzepatide, DRUG FOR FURTHER PROCESSING Regulator openFDA
Tirzepatide, DRUG FOR FURTHER PROCESSING Regulator openFDA

TRIAL SPONSOR

138 companies

Sponsors registered clinical trials of the peptide.

Eli Lilly & Company
79 registered trials Trial register ClinicalTrials.gov
Brigham and Women's Hospital
11 registered trials Trial register ClinicalTrials.gov
ELI LILLY AND CO
6 registered trials Trial register EU CTIS
Novo Nordisk A/S
1 registered trial Trial register EU CTIS
4 registered trials Trial register ClinicalTrials.gov
Dasman Diabetes Institute
3 registered trials Trial register ClinicalTrials.gov
Mayo Clinic
3 registered trials Trial register ClinicalTrials.gov
Nanjing First Hospital, Nanjing Medical University
3 registered trials Trial register ClinicalTrials.gov
Shahid Beheshti University of Medical Sciences
3 registered trials Trial register ClinicalTrials.gov
The Cleveland Clinic
3 registered trials Trial register ClinicalTrials.gov
University Medical Centre Ljubljana
3 registered trials Trial register ClinicalTrials.gov
University of Texas Southwestern Medical Center
3 registered trials Trial register ClinicalTrials.gov
Azienda Sanitaria Locale Napoli 2 Nord
2 registered trials Trial register ClinicalTrials.gov
Cambridge University Hospitals NHS Foundation Trust
2 registered trials Trial register ClinicalTrials.gov
Johns Hopkins University
2 registered trials Trial register ClinicalTrials.gov
Massachusetts General Hospital
2 registered trials Trial register ClinicalTrials.gov
National and Kapodistrian University of Athens
2 registered trials Trial register ClinicalTrials.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
2 registered trials Trial register ClinicalTrials.gov
Pennington Biomedical Research Center
2 registered trials Trial register ClinicalTrials.gov
Rutgers, The State University of New Jersey
2 registered trials Trial register ClinicalTrials.gov
Stanford University
2 registered trials Trial register ClinicalTrials.gov
The University of Texas Health Science Center at San Antonio
2 registered trials Trial register ClinicalTrials.gov
UNC Lineberger Comprehensive Cancer Center
2 registered trials Trial register ClinicalTrials.gov
University of Colorado, Denver
2 registered trials Trial register ClinicalTrials.gov
University of Southern California
2 registered trials Trial register ClinicalTrials.gov
Washington University School of Medicine
2 registered trials Trial register ClinicalTrials.gov
Yunlong Wang
2 registered trials Trial register ClinicalTrials.gov
Zagazig University
2 registered trials Trial register ClinicalTrials.gov
Akhtar Saeed Medical and Dental College
1 registered trial Trial register ClinicalTrials.gov
Alaa Sada
1 registered trial Trial register ClinicalTrials.gov
Ali Aminian
1 registered trial Trial register ClinicalTrials.gov
Alnylam Pharmaceuticals
1 registered trial Trial register ClinicalTrials.gov
Anders Fink-Jensen, MD, DMSci
1 registered trial Trial register ClinicalTrials.gov
Arrowhead Pharmaceuticals
1 registered trial Trial register ClinicalTrials.gov
Ascletis Pharma (China) Co., Limited
1 registered trial Trial register ClinicalTrials.gov
Baylor Research Institute
1 registered trial Trial register ClinicalTrials.gov
BioAge Labs, Inc.
1 registered trial Trial register ClinicalTrials.gov
Biomed Industries, Inc.
1 registered trial Trial register ClinicalTrials.gov
BrightGene Bio-Medical Technology Co., Ltd.
1 registered trial Trial register ClinicalTrials.gov
Cardenal Herrera University
1 registered trial Trial register ClinicalTrials.gov
China-Japan Friendship Hospital
1 registered trial Trial register ClinicalTrials.gov

Showing 40 of 138.

WARNING LETTER RECIPIENT

110 companies

Received an FDA warning letter naming the peptide.

24HrDoc, Inc. dba 24HrDoc
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
Alan Health Technologies Inc. dba Alan
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
All American Wellness
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Altru Telehealth, LLC dba Altru Telehealth
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
Amie Health, Inc. dba Amie
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
Apothecary Pharma, LLC
Compounding Pharmacy/Adulterated Drug Products, 2025-12-01 Regulator FDA warning letters
Aspen Aesthetics dba Fifty 410
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
Belle Health LLC dba Belle
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
Better Health Labs, Inc. dba Measured
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
Bioverse, Inc. dba Bioverse
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Bliv Wellness LLC dba Bliv
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
BluefitMD
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
Boothwyn Pharmacy LLC
Compounding Pharmacy/Adulterated Drug Products, 2026-01-16 Regulator FDA warning letters
Clover Meds LLC dba Clover Meds
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
Curex
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
D&H Medical Services
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
directmeds.com, Inc. dba DirectMeds
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Dr. Gater’s Weight Loss & Wellness
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Dripgym Mobile Parent, LLC dba Amp Health
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
EA WORKS Limited Liability Company dba Trust Labs
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Eden Health International Inc. dba Eden
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
eDrugstore
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Elevate Your Wellness LLC, dba Elevated
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Eli Lilly & Company
False & Misleading Claims/Misbranded, 2025-09-09 Regulator FDA warning letters
Empower Clinic Services, LLC dba Empower Pharmacy
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug, 2026-09-18 Regulator FDA warning letters
EvoLife Wellness
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Expert Aesthetics
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Ezra Holdco LLC dba Ezra
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
Fancy Meds, LLC dba Fancy Meds
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
FITISH
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
FitRX, LLC dba AM RX
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
FitRX, LLC dba FitRx
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
FWD Care, Inc. dba FWD
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Genesis Health International Inc. dba Genesis
False & Misleading Claims/Misbranded (Telehealth), 2026-02-20 Regulator FDA warning letters
GenLabMeds
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
GenoGenix LLC
Compounding Pharmacy/Adulterated Drug Products, 2026-01-20 Regulator FDA warning letters
Get.Fit.Medical, LLC dba Get.Fit.Medical
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters
Glow Medispa, LLC dba Mint Med
False & Misleading Claims/Misbranded (Telehealth), 2026-06-08 Regulator FDA warning letters
GLP-1 Solution
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth), 2025-09-09 Regulator FDA warning letters

Showing 40 of 110.

RECALLING FIRM

6 companies

Recalled a product naming the peptide (FDA enforcement report).

AEQUITA PHARMACY
Class II recall, Ongoing, 2025-08-13 Regulator openFDA
GenoGenix LLC
Class II recall, Ongoing, 2025-10-15 Regulator openFDA
New Life Pharma LLC
Class II recall, Ongoing, 2026-03-11 Regulator openFDA
ProRx LLC
Class II recall, Ongoing, 2024-09-11 Regulator openFDA
Class II recall, Ongoing, 2025-11-05 Regulator openFDA
Revive Rx LLC dba Revive Rx Pharmacy
Class I recall, Ongoing, 2024-06-05 Regulator openFDA
Class II recall, Ongoing, 2023-05-31 Regulator openFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class II recall, Ongoing, 2025-07-02 Regulator openFDA

Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings. Trade between countries in all polypeptide hormones, Tirzepatide among them: trade.

WEEKLY

Register Watch, weekly

New trials, approvals and enforcement actions. One email a week.