Molecules / Baricitinib

Baricitinib API manufacturers

CAS 1187594-09-7 ATC L04AA37 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
57
finished-dose makers across 35 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for baricitinib, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

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

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for baricitinib, filing since 2024. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Apitoria Pharma

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

Holds one active US DMF for baricitinib, filing since 2021. 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
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04

Wisdom Pharmaceutical

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

Holds one active US DMF for baricitinib, filing since 2022. 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
05
Credentials confirmed against the regulator files on 25 July 2026

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

4 more manufacturers hold filings for baricitinib

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

Wisdom PharmaceuticalChunghwa Chemical Synthesis & BiotechNanjing Libravo PharmaceuticalTongsheng Pharmaceutical (Jingmen)
Open the full list with a free account

Contract manufacturers (2)

Chunghwa Chemical Synthesis & Biotech Taiwan Anhui Biochem Pharmaceutical China

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

Finished-dose makers (14)

Eli Lilly And United States Hetero India Lilly Spain Torrent Pharmaceuticals India Natco Pharma India Viatris United States BDR Lifesciences India Lilly Del Caribe Puerto Rico BDR Lifesciences India Honour Lab India Oneiro Chemicals India Pharma Apex Saudi Arabia Laboratorio Varifarma S A Argentina Aurobindo Pharma India

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

Recalls 1 Finished dose 14 Contract mfrs 2

By country

China 6