Pyridone
Where is Pirfenidone made?
24 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 14 factories in India and the United States.
India 9United States 5
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals267 mg, 801 mg · NDC 69238-1640, 69238-1642, 60219-1642 +3 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Novadoz Pharmaceuticals LLC267 mg, 801 mg · NDC 72205-181, 72205-182 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| ANI Pharmaceuticals, Inc.267 mg, 801 mg · NDC 70954-869, 70954-870 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Accord Healthcare Inc.267 mg, 801 mg · NDC 16729-467, 16729-468 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Alembic Pharmaceuticals Inc.267 mg, 801 mg · NDC 62332-479, 62332-480 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited267 mg, 801 mg · NDC 46708-479, 46708-480 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited267 mg, 801 mg · NDC 59651-238, 59651-244, 59651-239 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Camber Pharmaceuticals Inc.267 mg, 801 mg · NDC 31722-872, 31722-873 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Cipla USA., Inc.267 mg, 801 mg · NDC 69097-940, 69097-987, 69097-988 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| CivicaScript LLC267 mg, 801 mg · NDC 82249-115, 82249-116 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Exelan Pharmaceuticals, Inc.267 mg, 801 mg · NDC 76282-717, 76282-715, 76282-716 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Laurus Labs Limited267 mg, 534 mg, 801 mg · NDC 42385-923, 42385-924, 42385-925 +1 | Laurus Labs LimitedMakes it, makes the active ingredient and tests it | Anakapalli, India | Problems found, fixed voluntarilyFeb 2023 |
| Legacy Pharma USA, Inc. Esbriet267 mg, 801 mg · NDC 83107-028, 83107-029 | Ferndale Laboratories, Inc.Makes it, tests it, packages it and labels it | Ferndale, MI, United States | Problems found, fixed voluntarilyFeb 2026 |
| Macleods Pharmaceuticals Limited267 mg · NDC 33342-461 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Major Pharmaceuticals267 mg, 801 mg · NDC 0904-7397, 0904-7398 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Micro Labs Limited267 mg, 801 mg · NDC 42571-335, 42571-336 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.267 mg, 801 mg · NDC 72603-258, 72603-259 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| ScieGen Pharmaceuticals, Inc.267 mg, 801 mg · NDC 50228-442, 50228-441, 50228-443 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Apotex Corp.267 mg, 801 mg · NDC 60505-4681, 60505-4682 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.267 mg, 801 mg · NDC 42291-490, 42291-491, 42291-492 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Genentech, Inc. Esbriet267 mg, 801 mg · NDC 50242-121, 50242-122, 50242-123 | The label doesn't name the factory. Plants this company names for other drugs | ||
| InterMune, Inc. Esbriet267 mg · NDC 64116-121 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.267 mg, 801 mg · NDC 0781-8085, 0781-2158, 0781-8086 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.267 mg, 801 mg · NDC 0480-3610, 0480-3611 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pirfenidone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
72162-2465,71335-2944,72162-2466,71335-2984 - Golden State Medical Supply, Inc.:
51407-913,51407-914
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 2 recall notices
CGMP Deviations: recalling drug products following an FDA inspection.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.