Molecules / Tirzepatide

Tirzepatide API manufacturers

CAS 2023788-19-2 ATC A10BX16 Updated 9 July 2026
34
manufacturers with an active filing 33 of them hold a US DMF or a CEP
6
shortage records on file across 1 countries
46
finished-dose makers across 32 regulators
Showing 20 of 34 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Biocon

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Hybio Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Alembic Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

MSN Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2026. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Apicore

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2024. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Changzhou Pharmaceutical Factory

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for tirzepatide, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Fujian Genohope Biotech

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2024. Its 2026 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Sinopep-Allsino Biopharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2024. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Zhejiang Peptites Biotech

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tirzepatide, filing since 2024. Its 2023 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Chengdu Shengnuo Biopharm

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Yangzhou Aurisco Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2025. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Allsino Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tirzepatide, filing since 2025.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Guizhou Utide Biotechnology

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2025.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Hangzhou Thinheal Pharma-Tech

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tirzepatide, filing since 2024.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

31 more manufacturers hold filings for tirzepatide

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Alembic PharmaceuticalsMSN LaboratoriesApicoreChangzhou Pharmaceutical FactoryFujian Genohope BiotechSinopep-Allsino BiopharmaceuticalZhejiang Peptites BiotechChengdu Shengnuo BiopharmHangzhou Apextide Biomedical TechnologyYangzhou Aurisco PharmaceuticalAllsino PharmaceuticalAlp Pharm BeijingEl-Peptido (Shanghai) BiopharmaceuticalGuizhou Utide BiotechnologyHangzhou Hotide Biotech Co.,LtdHangzhou Thinheal Pharma-TechNanjing Cellnuo Biopharmaceutical
Open the full list with a free account

Contract manufacturers (8)

Fujian Genohope Biotech China Allsino Pharmaceutical China Chemspec Api United States Guizhou Utide Biotechnology China Fenhe Chemical China Nanjing Cellnuo Biotechnology China Omgene Life Sciences India Penmix Dominican Republic

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (5)

Eli Lilly And United States Lilly Spain Bsp Pharmaceuticals Italy Dawa Kenya BioVectra Canada

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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Also on this molecule

Shortages 6 Recalls 28 Finished dose 5 Contract mfrs 8

By country

China 29 India 6