Molecules / Semaglutide

Semaglutide API manufacturers

CAS 910463-68-2 ATC A10BJ06 Updated 9 July 2026
61
manufacturers with an active filing 59 of them hold a US DMF or a CEP
14
shortage records on file across 3 countries
109
finished-dose makers across 40 regulators
Showing 20 of 61 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for semaglutide, filing since 2021. 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

FDC

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

Holds one active US DMF for semaglutide, filing since 2026. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Biocon

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

Holds one active US DMF for semaglutide, filing since 2024. 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
04

Hybio Pharmaceutical

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

Holds 3 active US DMFs for semaglutide, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
3 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
05

Piramal Pharma

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

Holds one active US DMF for semaglutide, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

MSN Life Sciences

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

Holds one active US DMF for semaglutide, filing since 2023. 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
07

Zydus Lifesciences

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

Holds one active US DMF for semaglutide, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Sinopep-Allsino Biopharmaceutical

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

Holds 3 active US DMFs for semaglutide, filing since 2021. Its 2024 FDA inspection closed as VAI.

US DMF
3 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
09

Auro Peptides

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Bachem

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

Holds one active US DMF for semaglutide, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 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
12

Changzhou Pharmaceutical Factory

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

Holds 3 active US DMFs for semaglutide, 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
13

Qilu Pharmaceutical

China
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for semaglutide. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

ScinoPharm Taiwan

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

Holds one active US DMF for semaglutide, filing since 2025. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Apicore Pharmaceuticals

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Fujian Genohope Biotech

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

Holds 4 active US DMFs for semaglutide, filing since 2024. Its 2026 FDA inspection closed as VAI.

US DMF
4 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
17

Suzhou Lixin Pharmaceutical

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

Holds one active US DMF for semaglutide, filing since 2025. Its 2023 FDA inspection closed as VAI.

US DMF
1 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
18

Zhejiang Peptites Biotech

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

Holds 4 active US DMFs for semaglutide, filing since 2021. Its 2023 FDA inspection closed as VAI.

US DMF
4 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
19
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for semaglutide, filing since 2023. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Anhui Poly Pharm

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

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

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

58 more manufacturers hold filings for semaglutide

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

Hybio PharmaceuticalPiramal PharmaMSN Life SciencesZydus LifesciencesSinopep-Allsino BiopharmaceuticalAuro PeptidesHangzhou Zhongmeihuadong Pharmaceutical JiangdongBachemChangzhou Pharmaceutical FactoryQilu PharmaceuticalScinoPharm TaiwanApicore PharmaceuticalsFujian Genohope BiotechSuzhou Lixin PharmaceuticalZhejiang Peptites BiotechHangzhou Zhongmei Huadong PharmaceuticalAnhui Poly Pharm
Open the full list with a free account

Contract manufacturers (13)

Swiss Parenterals India Aurisco Pharmaceutical Co.,Ltd China Chunghwa Chemical Synthesis & Biotech Taiwan Fujian Genohope Biotech China Allsino Pharmaceutical China Chemspec Api United States Guizhou Utide Biotechnology China Genovior Biotech Taiwan Fenhe Chemical China Molsyns Research India Penmix Dominican Republic Shijiazhuang Xinfuda Medical Packaging China Synzeal Research India

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

Finished-dose makers (12)

Novo Nordisk A/S Denmark Hetero India Torrent Pharmaceuticals India Chongqing Chen'An Biopharmaceutical China Onesource Specialty Pharma India Aykon Biosciences India Natco Pharma India Alkem Laboratories India Gufic Biosciences India Hovione Farmaciência Portugal Livzon New North River Pharmaceutical China Boston Oncology Arabia Saudi Arabia

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 14 Recalls 51 Finished dose 12 Contract mfrs 13

By country

China 20 India 13