Molecules / Roflumilast / India

Roflumilast API manufacturers in India

CAS 162401-32-3 ATC R03DX07 Updated 9 July 2026
7
India-based manufacturers with an active filing of 16 worldwide
Showing 7 of 7 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Torrent Pharmaceuticals

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

Holds one active US DMF for roflumilast, filing since 2021. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

MSN Laboratories

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

Holds one active US DMF for roflumilast, filing since 2013. 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
View profile
03

Hetero

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

Holds 2 active US DMFs for roflumilast, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

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

Zydus Lifesciences

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

Holds one active US DMF for roflumilast, filing since 2014. 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
05

Alivus Life Sciences

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

Holds 2 active US DMFs for roflumilast, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Apitoria Pharma

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

Holds one active US DMF for roflumilast, filing since 2018. 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
07

Matrix Pharmacorp

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

Holds one active US DMF for roflumilast, filing since 2014. 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

How this list is built

This page filters the worldwide Roflumilast manufacturer list to companies based in India. 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. Read the full method.

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