Pirfenidone

Overview

Pirfenidone is a pyridine derivative with antifibrotic properties used to treat idiopathic pulmonary fibrosis by reducing lung fibrosis through modulation of the cytokine cascade. It is believed to exert its therapeutic effects by inhibiting TGF-beta and collagen synthesis and decreasing fibroblast proliferation.

API suppliers (28)

Suppliers of Pirfenidone evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• PROCOS SPAItaly1 active DMF GMP on record
• HONOUR LAB LTDIndia1 active DMF GMP on record
• SIGNA SA DE CV1 active DMF
• Granules India LimitedIndia1 active DMF GMP on record
• Lupin LimitedIndia1 active DMF GMP on record
• Laurus Labs LimitedIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• OPTIMUS DRUGS PRIVATE LTDIndia1 active DMF
• COHANCE LIFESCIENCES LTDIndia1 active DMF GMP on record
• Dipharma Francis SrlItaly1 active DMF GMP on record
• RAKS PHARMA PVT LTDIndia1 active DMF
• JUBILANT BIOSYS LTDIndia1 active DMF
• Cipla USA, Inc.USA1 active DMF
• Micro Labs Usa1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• VERANOVA LPUnited Kingdom1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• CHEMO IBERICA SA1 active DMF
• AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)India1 active DMF
• SMS Pharmaceuticals limitedIndia1 active DMF GMP on record
• CHEMECA DRUGS PRIVATE LTDIndia1 active DMF

Showing 25 of 28 suppliers — see the full list in the app.

EU CEP holders (20)

Companies holding a valid EU Certificate of Suitability (CEP) for Pirfenidone, 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.

Patent & exclusivity (US)

Per the FDA Orange Book (38 approved US products), the latest listed US patent on Pirfenidone expires 28 Mar 2037. Generic API sourcing typically opens up once these lapse.

Therapeutic areas