Medicine
Nerlynx 40 mg tablet
Nerlynx 40 mg tablet is a prescription medicine containing Neratinib for oral use, marketed by Puma Biotechnology, 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 controlled room temperature, 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Neratinib
- Brand
- Nerlynx
- Strength
- 40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Puma Biotechnology
- Manufacturer
- Puma Biotechnology
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EH02 Neratinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 July 2017
- Identifiers
- RxCUI 1940648, 1940654DailyMed set ID d1e41dcf-e82a-47c2-a0ad-6c6eef621834NDC 70437-240Application NDA208051
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 box / 180 tablet in 1 bottle | 70437-240-18 | Puma Biotechnology | 17 July 2017 |
| 1 bottle in 1 box / 126 tablet in 1 bottle | 70437-240-26 | Puma Biotechnology | 17 July 2017 |
| 1 bottle in 1 box / 133 tablet in 1 bottle | 70437-240-33 | Puma Biotechnology | 17 July 2017 |
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
Clinical summary
Neratinib is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy, among other approved uses. MedsAcross supplies Neratinib 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 NeratinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nerlynx prescribing information (Puma Biotechnology) · U.S. National Library of Medicine, DailyMed
- Nerlynx: European public assessment report (EPAR) · European Medicines Agency
Need Nerlynx 40 mg tablet 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.