Leflunomide
Overview
Leflunomide is an immunomodulatory drug primarily used for the treatment of active moderate to severe rheumatoid arthritis. It works by inhibiting dihydroorotate dehydrogenase, an enzyme involved in pyrimidine synthesis, thus reducing lymphocyte proliferation.
API suppliers (9)
Suppliers of Leflunomide evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 8 of 9 suppliers.
7 of 9 hold a GMP certificate on record in the EU or UK registers · 1 holds a European CEP for this substance
- EUROAPI GERMANY GMBHGermany1 active DMF GMP on record
- Formosa Laboratories, Inc.Taiwan1 active DMF GMP on record
- Cipla USA, Inc.USA1 active DMF
- Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
- Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
- MAPRIMED SAArgentina1 active DMF GMP on record
- RAKSHIT DRUGS PRIVATE LTD1 active DMF
- Cipla LimitedIndiaCEP GMP on record
- Unichem Laboratories Ltd.India GMP on record
EU CEP holders (4)
Companies holding a valid EU Certificate of Suitability (CEP) for Leflunomide, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.
Therapeutic areas
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