Medicine
Nintedanib 100 mg capsule
Nintedanib 100 mg capsule is a generic prescription medicine for oral use, made by 11 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Nintedanib
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 1 bottle and 8 more
- Manufacturers
- CiplaIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaApotexAvKAREEdenbridge PharmaceuticalsEpic PharmaExelan PharmaceuticalsGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from exposure to high humidity and avoid excessive heat.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EX09 Nintedanib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 February 2026
- Identifiers
- RxCUI 1592742, 1592750DailyMed set ID b14164fb-0276-4ad1-a5ff-400ab9e292da, 4ecf7f05-4a95-b98c-e063-6394a90ab896, 751c3473-35d6-47d6-b405-af16a989716c +8NDC 68462-802, 51407-984, 0781-2492 +8Application ANDA212555, ANDA219819, ANDA216915 +5
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 |
|---|---|---|---|
| 60 capsule in 1 bottle | 69097-641-03 | CiplaIndia | 2 April 2026 |
| 60 capsule in 1 bottle | 43598-148-60 | Dr. Reddy's LaboratoriesIndia | 2 April 2026 |
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 68462-802-60 | Glenmark PharmaceuticalsIndia | 9 July 2026 |
| 60 capsule in 1 bottle | 33342-550-09 | Macleods PharmaceuticalsIndia | 3 August 2026 |
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 60505-4818-6 | Apotex | 2 April 2026 |
| 60 capsule in 1 bottle | 42799-972-01 | Edenbridge Pharmaceuticals | 3 April 2026 |
| 60 capsule in 1 bottle | 42806-569-60 | Epic Pharma | 9 July 2026 |
| 60 capsule in 1 bottle | 76282-786-60 | Exelan Pharmaceuticals | 7 May 2026 |
| 60 capsule in 1 bottle | 0781-2492-60 | Sandoz | 2 April 2026 |
| 60 capsule in 1 bottle | 73190-096-60 | AvKARE | 21 July 2026 |
| 60 capsule in 1 bottle | 51407-984-60 | Golden State Medical Supply | 15 February 2026 |
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
Alternatives
Other makers and brands of Nintedanib 100 mg capsule.
Other strengths and forms of Nintedanib
Clinical summary
Nintedanib is a kinase inhibitor indicated in adults for treatment of idiopathic pulmonary fibrosis (IPF), among other approved uses. It is available as capsules for oral use. MedsAcross supplies Nintedanib 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 NintedanibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ofev prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ofev: European public assessment report (EPAR) · European Medicines Agency
- Vargatef: European public assessment report (EPAR) · European Medicines Agency
Need Nintedanib 100 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.