Medicine
Zejula 100 mg tablet
Zejula 100 mg tablet is a prescription medicine containing Niraparib for oral use, marketed by GlaxoSmithKline, 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 are permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Niraparib
- Brand
- Zejula
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Store and dispense in the original bottle.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XK02 Niraparib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 June 2023
- Identifiers
- RxCUI 2637449, 2637452, 2637465 +3DailyMed set ID b7f675e2-159c-490c-b6f4-3f16d9492b7dNDC 0173-0909Application NDA214876
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 0173-0909-13 | GlaxoSmithKline | 27 June 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 Niraparib
Clinical summary
Niraparib is a Poly(ADP-Ribose) polymerase inhibitor indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. MedsAcross supplies Niraparib 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 NiraparibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZEJULA prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
- Zejula: European public assessment report (EPAR) · European Medicines Agency
Need Zejula 100 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.