Zejula (niraparib) is dosed once daily at an individualised starting dose of 200 mg or 300 mg, set by the patient's baseline weight and platelet count rather than a single fixed strength.
Zejula (niraparib) is GSK's oral PARP inhibitor for ovarian cancer maintenance, and it is the only drug in its class dosed by an individualised weight-and-platelet algorithm rather than one fixed strength. M Care sources Zejula through licensed Indian distribution channels as a merchant exporter, matching tablet strength mix to what a tender or hospital pharmacy actually needs.
Niraparib exporter and bulk supplier from India.
Tender and bulk buyers sourcing Zejula need all three tablet strengths on the shelf at once, because the starting dose (200 mg or 300 mg) and every subsequent dose reduction (300 mg to 200 mg to 100 mg) is set per patient. M Care coordinates procurement across the 100 mg, 200 mg and 300 mg presentations through licensed Indian channels, so an MoH tender desk or hospital pharmacy can hold a working stock mix rather than reordering strength-by-strength mid-cycle. Dispatch is arranged against firm purchase orders with the CTD/eCTD documentation destination regulators expect.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
PARP (poly ADP-ribose polymerase) inhibitor, sourced and documented for export.
Niraparib is a small-molecule PARP (poly ADP-ribose polymerase) inhibitor. It blocks DNA repair in tumour cells that already carry a homologous recombination deficiency, causing synthetic lethality in susceptible ovarian cancer cells.
Zejula is licensed for maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in adults, in two settings per the FDA label: first-line maintenance in patients with HRD-positive disease (deleterious or suspected BRCA mutation and/or genomic instability) responding to platinum-based chemotherapy, and maintenance in recurrent, germline BRCA-mutated disease in complete or partial response to platinum-based chemotherapy. Buyers should confirm the exact licensed wording and any biomarker-testing requirement against destination-country labelling, since indication scope can vary by market.
Zejula is supplied as oval film-coated tablets in three strengths (100 mg, 200 mg and 300 mg), taken orally once daily with or without food. It is a room-temperature product: store at 20-25C, with excursions permitted between 15-30C. It does not require cold-chain handling.
Active ingredient
niraparib. PARP (poly ADP-ribose polymerase) inhibitor.
Forms and strengths
100 mg tablet; 200 mg tablet; 300 mg tablet.
Indications
Oral PARP inhibitor licensed for maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, in first-line HRD-positive disease and in recurrent germline BRCA-mutated disease responding to platinum-based chemotherapy.
Administration
oral. Oval film-coated tablets.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Zejula moves through oncology-specialist hospital pharmacies, private and NHS-linked cancer centres, MoH tender desks running gynaecological-oncology procurement lines, and licensed importers/wholesalers stocking targeted oncology portfolios across the GCC, Africa and Europe. NGO procurement bodies are a smaller channel for this molecule than for infectious-disease drugs, given its specialist, biomarker-gated use.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on niraparib.
Starting dose is not one-size-fits-all. For first-line HRD-positive maintenance, a patient under 77 kg or with a baseline platelet count under 150,000/mcL starts at 200 mg once daily; a patient at or above 77 kg with a baseline platelet count at or above 150,000/mcL starts at 300 mg once daily. Recurrent, germline BRCA-mutated maintenance starts flat at 300 mg once daily regardless of weight or platelets. Get this wrong at intake and the patient is over- or under-dosed from day one.
Tablets are swallowed whole, not chewed, crushed or split, and can be taken with or without food. A missed dose is simply skipped, not doubled up at the next scheduled time. That single instruction is worth putting on the counselling sheet, because PARP-inhibitor regimens run for months and adherence lapses are common.
Haematology monitoring drives most of the dose-adjustment workload: weekly for the first month, monthly for the next eleven months, then periodically. Thrombocytopenia under 100,000/mcL, neutrophils under 1,000/mcL or haemoglobin under 8 g/dL are the triggers to withhold dosing for up to 28 days before resuming, usually at a reduced strength. The reduction pathway runs 300 mg to 200 mg to 100 mg, and any non-haematologic Grade 3 or higher toxicity follows the same 28-day-withhold rule with resumption at the next lower strength; the drug is discontinued if toxicity has not resolved by then even at the 100 mg floor.
Moderate hepatic impairment gets a flat 200 mg once daily regardless of the weight/platelet table, which is a common miss at reconciliation for oncology patients with borderline liver function. Storage is straightforward: keep tablets in the original bottle at 20-25C, no cold chain and no reconstitution step, which simplifies onward distribution once the shipment clears customs.
The documentation pack a regulator actually asks for.
Zejula is an oral solid, so the documentation chain runs on standard pharmaceutical-import paperwork rather than cold-chain logistics records: CTD/eCTD-format product dossiers, GMP compliance evidence from the originator's licensed distribution channel, batch certificates of analysis, and CDSCO export documentation from the Mumbai desk. Destination-market import registration (MHRA, SFDA, MOHAP, NAFDAC, SAHPRA or the relevant national authority) remains the buyer's or their local agent's responsibility; M Care supplies the manufacturer- and batch-level paperwork needed to support that filing.
Niraparib remains patent-protected in the United States and the European Union, and no licensed generic version currently appears in FDA or EMA product registries. Zejula is therefore sourced exclusively through GlaxoSmithKline's licensed Indian distribution channels, not from generic manufacturers. Buyers should treat any offer of a 'generic niraparib' outside that channel with the same scrutiny they would apply to any other unlisted originator brand.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside niraparib.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for niraparib.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Niraparib supply, the specific questions.
Is there a generic or biosimilar version of niraparib?
Niraparib is a small-molecule drug, so 'biosimilar' does not apply to it; the comparison is with a generic. As things stand, no FDA- or EMA-approved generic niraparib is on the market. Zejula remains under patent and is sourced through GlaxoSmithKline's licensed Indian distribution channels rather than from generic manufacturers.
Can M Care supply Zejula to my country?
Yes. M Care exports Zejula as a merchant exporter, sourcing through licensed Indian distribution channels and dispatching against firm purchase orders. Local import registration and any national tender requirements sit with the buyer or their in-country agent; we supply the CTD/eCTD dossier and batch documentation to support that process.
Does Zejula need cold-chain shipping?
No. Zejula tablets are stored at 20-25C, with excursions permitted between 15-30C, so shipments move as a standard room-temperature pharmaceutical consignment rather than a cold-chain lane.
Why does the Zejula starting dose vary between patients?
The FDA label sets the first-line maintenance starting dose by baseline body weight and platelet count: 200 mg once daily below 77 kg or a platelet count under 150,000/mcL, 300 mg once daily at or above both thresholds. Recurrent BRCA-mutated maintenance starts at a flat 300 mg. Buyers stocking for oncology tenders should plan for a mix of all three tablet strengths rather than one dominant SKU.
What tablet strengths and pack sizes does Zejula come in?
Zejula is supplied as oval film-coated tablets in 100 mg, 200 mg and 300 mg strengths. All three are needed to cover starting doses and the down-titration pathway used when a patient develops toxicity.
What documentation does M Care provide with a Zejula shipment?
Each consignment is supported by CTD/eCTD-format dossiers, batch certificates of analysis, and CDSCO export paperwork from the Mumbai desk, alongside the manufacturer-chain evidence a destination regulator or tender authority typically requests.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.