Drug
Who makes pirfenidone?
22 companies list pirfenidone as a human prescription drug, including under the names ESBRIET. Forms: capsule; tablet; tablet, coated; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing pirfenidone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | capsule; tablet, film coated | ANDAANDA212569, ANDA212570 | 6 | 0 |
| Alembic Pharmaceuticals LimitedIndia | tablet, coated | ANDAANDA212708 | 4 | 7 |
| LAURUS LABS LIMITEDIndia | capsule; tablet, film coated | ANDAANDA212722, ANDA212724 | 4 | 5 |
| Bryant Ranch PrepackUnited States | tablet, coated | ANDAANDA212708 | 4 | 1 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | capsule; tablet, coated | ANDAANDA212077, ANDA212078 | 3 | 7 |
| Aurobindo Pharma LimitedIndia | capsule; tablet | ANDAANDA212596, ANDA212597 | 3 | 6 |
| Sandoz Industrial Products S.AAustria | capsule; tablet, film coated | ANDAANDA212560, ANDA212600 | 3 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | capsule; tablet | ANDAANDA212077, ANDA212078 | 3 | 3 |
| AvKARE | capsule; tablet, film coated | ANDAANDA212569, ANDA212570 | 3 | 0 |
| Exelan Pharmaceuticals, Inc. | capsule; tablet, coated | ANDAANDA212077, ANDA212078 | 3 | 0 |
| Genentech, Inc.United States | tablet, coated | NDANDA208780 | 2 | 8 |
| Apotex Inc.Canada | tablet | ANDAANDA212709 | 2 | 6 |
| Micro Labs LimitedIndia | tablet, film coated | ANDAANDA212680 | 2 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA212730 | 2 | 2 |
| ANI Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA212722 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA212674 | 2 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA212709 | 2 | 1 |
| Legacy Pharma USA Inc.United States | tablet, coated | NDANDA208780 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA212772 | 2 | 0 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA212772 | 2 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA212772 | 2 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA212759 | 1 | 6 |
Bulk ingredient listings
- PROCOS SpAItaly · 2 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Chemeca Drugs Private LimitedIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Dipharma Francis SrlItaly · 1 NDC
- Granules Pharmaceuticals Inc.India · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- LAURUS LABS LIMITEDIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Micro Labs LimitedIndia · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- RAKS Pharma Pvt. LimitedIndia · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Signa S.A. de C.V.Mexico · 1 NDC
- TYCHE INDUSTRIES LIMITEDIndia · 1 NDC
Orange Book patents
17 unexpired patents list pirfenidone as the active ingredient, expiring between Dec 2027 and Mar 2037. Application holder: LEGACY PHARMA INC SEZC.
Enquiry
Common questions
- Who makes pirfenidone?
- 22 companies list pirfenidone as a human prescription drug in the openFDA NDC Directory, led by Amneal Pharmaceuticals NY LLC, Alembic Pharmaceuticals Limited, LAURUS LABS LIMITED, Bryant Ranch Prepack, CIPLA PHARMACEUTICALS LIMITED. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ESBRIET?
- 20 companies list pirfenidone under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies pirfenidone active ingredient?
- 18 companies list pirfenidone as a bulk ingredient, including PROCOS SpA, Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED.