Medicine
Pirfenidone 267 mg capsule
Pirfenidone 267 mg capsule is a generic prescription medicine for oral use, made by 9 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Pirfenidone
- Brand
- Sold under the generic name
- Strength
- 267 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle, 4 blister pack, 1 blister pack and 16 more
- Manufacturers
- Aurobindo PharmaIndiaLaurus LabsIndiaMacleods PharmaceuticalsIndiaCiplaIndiaAmneal Pharmaceuticals NYExelan PharmaceuticalsScieGen PharmaceuticalsAvKARESandoz
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AX05 Pirfenidone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 July 2020
- Identifiers
- RxCUI 1592279, 1868014, 1868018 +2DailyMed set ID 29b0fd0e-5a2b-4da7-8524-177dc28bf55e, 1fbdb556-b164-4e0b-a95e-6004d50e3364, 1d4d7aa2-1248-4639-baf5-5e2ae72cbcd8 +7NDC 42385-923, 50228-441, 60219-1642 +7Application ANDA212724, ANDA212077, ANDA212569 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 270 capsule in 1 bottle | 59651-244-27 | Aurobindo PharmaIndia | 20 April 2026 |
| 4 blister pack in 1 carton / 63 capsule in 1 blister pack | 59651-244-28 | Aurobindo PharmaIndia | 20 April 2026 |
| 1 blister pack in 1 carton / 63 capsule in 1 blister pack | 59651-244-42 | Aurobindo PharmaIndia | 20 April 2026 |
| 90 capsule in 1 bottle | 69097-940-04 | CiplaIndia | 2 August 2022 |
| 270 capsule in 1 bottle | 69097-940-93 | CiplaIndia | 2 August 2022 |
| 270 capsule in 1 bottle | 42385-923-29 | Laurus LabsIndia | 19 July 2022 |
| 4 blister pack in 1 carton / 63 capsule in 1 blister pack | 42385-923-54 | Laurus LabsIndia | 19 July 2022 |
| 2 blister pack in 1 carton / 21 blister pack in 1 blister pack / 42 capsule in 1 blister pack | 42385-923-63 | Laurus LabsIndia | 19 July 2022 |
| 1 blister pack in 1 carton / 63 capsule in 1 blister pack | 33342-461-38 | Macleods PharmaceuticalsIndia | 20 July 2020 |
| 270 capsule in 1 bottle | 33342-461-58 | Macleods PharmaceuticalsIndia | 20 July 2020 |
| 1 blister pack in 1 carton / 252 capsule in 1 blister pack | 33342-461-82 | Macleods PharmaceuticalsIndia | 20 July 2020 |
| 1 bottle in 1 carton / 270 capsule in 1 bottle | 60219-1642-7 | Amneal Pharmaceuticals NY | 7 January 2022 |
| 1 bottle in 1 carton / 270 capsule in 1 bottle | 69238-1642-7 | Amneal Pharmaceuticals NY | 7 January 2022 |
| 270 capsule in 1 bottle | 76282-715-27 | Exelan Pharmaceuticals | 2 August 2022 |
| 90 capsule in 1 bottle | 76282-715-90 | Exelan Pharmaceuticals | 2 August 2022 |
| 270 capsule in 1 bottle, plastic | 0781-2158-32 | Sandoz | 9 January 2023 |
| 500 capsule in 1 bottle | 50228-441-05 | ScieGen Pharmaceuticals | 1 August 2022 |
| 30 capsule in 1 bottle | 50228-441-30 | ScieGen Pharmaceuticals | 1 August 2022 |
| 1 bottle in 1 carton / 270 capsule in 1 bottle | 42291-490-27 | AvKARE | 18 October 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Pirfenidone
Clinical summary
Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). It is available as tablets and capsules for oral use. MedsAcross supplies Pirfenidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about PirfenidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ESBRIET prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Esbriet: European public assessment report (EPAR) · European Medicines Agency
- Pirfenidone axunio (previously Pirfenidone AET): European public assessment report (EPAR) · European Medicines Agency
Need Pirfenidone 267 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.