Molecules / Leflunomide / India

Leflunomide API manufacturers in India

CAS 75706-12-6 ATC L04AA13 Updated 9 July 2026
6
India-based manufacturers with an active filing of 9 worldwide
$787.40
median export price per kg, all origins $491.30 to $1042.92 · 24 exporters · 2025
Showing 4 of 6 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Alembic Pharmaceuticals

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

Holds one active US DMF and 2 valid CEPs for leflunomide, filing since 2002. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Cipla

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

Holds one active US DMF and 4 valid CEPs for leflunomide, filing since 2002. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Rakshit Pharmaceuticals

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

Holds one active US DMF for leflunomide, filing since 2026. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Bo Chem

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

Holds one valid CEP for leflunomide, filing since 2026.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile

2 more manufacturers in India hold filings for leflunomide

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

Rakshit PharmaceuticalsBo Chem
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How this list is built

This page filters the worldwide Leflunomide 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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All Leflunomide manufacturers

Worldwide 9