Molecules / Buprenorphine / India

Buprenorphine API manufacturers in India

CAS 52485-79-7 ATC N02AE01 Updated 9 July 2026
6
India-based manufacturers with an active filing of 16 worldwide
Showing 3 of 6 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Rusan Pharma

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

Holds 2 valid CEPs for buprenorphine, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
11 markets
02

Unichem Laboratories

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

Holds one valid CEP for buprenorphine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
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3 more manufacturers in India hold filings for buprenorphine

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

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How this list is built

This page filters the worldwide Buprenorphine 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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