Lynparza (olaparib) remains AstraZeneca's patented oral PARP inhibitor across ovarian, breast, prostate and pancreatic cancer labels, so tenders need licensed-brand sourcing, not a generic switch.
Lynparza (olaparib) is AstraZeneca's oral PARP inhibitor, licensed across BRCA-mutated and HRR/HRD-linked ovarian, breast, pancreatic and prostate cancer indications. M Care sources Lynparza through licensed Indian distribution channels as a merchant exporter. We do not manufacture it. We dispatch to hospital pharmacies, oncology centres and MoH tender desks across our served markets with the documentation those buyers need.
Olaparib exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care works from Lynparza's originator supply chain rather than a generic manufacturer base, since olaparib is still under patent protection in most of our served markets. We coordinate quantity, batch traceability and CTD-aligned documentation for MoH and NGO procurement desks, and flag destination-country patent and registration status before confirming any order, since import basis differs by market.
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.
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works by blocking PARP-mediated DNA repair in tumour cells that already carry a homologous recombination repair defect, most commonly a BRCA1/BRCA2 mutation, which drives cell death through synthetic lethality.
FDA-licensed indications include maintenance treatment of BRCA-mutated or HRD-positive advanced ovarian, fallopian tube or primary peritoneal cancer following first-line platinum chemotherapy (as monotherapy or with bevacizumab), plus maintenance treatment of recurrent BRCA-mutated ovarian, fallopian tube or primary peritoneal cancer in response to platinum-based chemotherapy; adjuvant treatment of high-risk, early-stage gBRCA-mutated, HER2-negative breast cancer and treatment of gBRCA-mutated, HER2-negative metastatic breast cancer; maintenance treatment of gBRCA-mutated metastatic pancreatic adenocarcinoma after platinum-based chemotherapy; and treatment of HRR gene-mutated metastatic castration-resistant prostate cancer as monotherapy, or of BRCA-mutated metastatic castration-resistant prostate cancer in combination with abiraterone. Buyers should confirm the current label for their destination market, since indications and required biomarker testing vary by regulator and other licensed indications may apply per destination-country labelling.
Lynparza is supplied as 100 mg and 150 mg film-coated tablets, dosed at 300 mg (two 150 mg tablets) twice daily as the standard regimen. It is an oral solid, stored at 20-25C with excursions to 15-30C permitted, and does not require cold-chain handling.
Active ingredient
olaparib. PARP (poly ADP-ribose polymerase) inhibitor.
Forms and strengths
100 mg tablet; 150 mg tablet.
Indications
Oral PARP inhibitor licensed for maintenance and treatment settings in BRCA-mutated or HRR/HRD-linked ovarian, breast, pancreatic and prostate cancer per FDA label.
Administration
oral. 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.
Enquiries typically come from oncology hospital pharmacies, private cancer centres, licensed wholesalers and MoH tender desks in our GCC and African markets stocking a PARP inhibitor for a BRCA-confirmed or HRR-positive patient cohort, alongside NGO and government procurement channels sourcing named-patient or small-batch oncology supply where local registration allows import.
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 olaparib.
Confirm biomarker status before dispensing. Ovarian, breast, pancreatic and prostate indications each carry their own BRCA/HRR/HRD testing requirement, and the eligible patient population, and sometimes the dose duration, differs by indication: for example, first-line ovarian maintenance with bevacizumab runs for up to two years, while adjuvant breast cancer treatment runs for one year.
Standard dosing is 300 mg (two 150 mg tablets) twice daily, with or without food. Tablets should be swallowed whole, not chewed, crushed, dissolved or split. The 100 mg and 150 mg tablets are not interchangeable on a mg-per-mg substitution basis with the earlier 50 mg capsule formulation, so check which formulation a receiving pharmacy is set up to dispense.
Dose adjustment is required for moderate renal impairment (CLcr 31-50 mL/min): reduce to 200 mg twice daily. Concomitant strong CYP3A inhibitors require reduction to 100 mg twice daily, and moderate CYP3A inhibitors to 150 mg twice daily; avoid strong or moderate CYP3A inducers where possible.
Anaemia and other haematological toxicity are the most frequently monitored adverse effects; baseline and monthly full blood counts are standard practice for the first year of treatment, with dose interruption or reduction as the label directs. Nausea is common early in treatment and is usually managed with antiemetics rather than discontinuation.
The documentation pack a regulator actually asks for.
Olaparib is an oral solid dose, so the documentation chain M Care builds is CTD/eCTD dossier support, batch certificates of analysis, and CDSCO export documentation from the licensed Indian distribution channel, rather than cold-chain validation records. Room-temperature logistics still call for moisture-protected packaging in transit, since the label specifies storage in the original bottle.
Lynparza remains patent-protected in the large majority of M Care's served markets, and no FDA-, EMA- or India-approved generic olaparib is broadly available in those markets at present. Where destination-country patent status or a locally licensed generic changes this position, M Care states that clearly to the buyer rather than assuming brand-only supply; buyers should always verify current registration and patent status for their specific country before confirming a tender.
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 olaparib.
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 olaparib.
- 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.
Olaparib supply, the specific questions.
Is there a generic version of olaparib?
Not broadly. Olaparib is still under patent protection in most of M Care's served markets, so Lynparza is the licensed-brand product available through our channels. Some bioequivalence work on generic olaparib is under way in select jurisdictions; where a locally licensed generic exists in a specific destination market, we will confirm that on enquiry rather than assume it.
Can M Care supply Lynparza to my country?
M Care sources Lynparza through licensed Indian distribution channels of the originator and dispatches to our served markets on an import basis appropriate to each destination's regulatory framework. Tell us the destination country and buyer type (hospital, MoH tender, NGO programme) and we will confirm the applicable import route and documentation.
Does Lynparza need cold-chain shipping?
No. Lynparza tablets are stored at 20-25C, with excursions to 15-30C permitted, and do not require refrigeration. They should stay in the original moisture-protective bottle and away from temperatures above 40C.
What biomarker testing does a buyer need to have in place before ordering?
That depends on the indication. Ovarian, breast, pancreatic and prostate cancer indications each require confirmation of germline or somatic BRCA mutation status, or HRR/HRD status, per the current label. We recommend hospital pharmacies confirm their oncology team has BRCA/HRR testing access before committing to a tender quantity.
What dose strengths does M Care supply?
Lynparza is manufactured as 100 mg and 150 mg film-coated tablets, dosed as 300 mg (two 150 mg tablets) twice daily in the standard regimen, with dose reductions available per the label for renal impairment or CYP3A interactions.
What documentation comes with a Lynparza order?
Batch certificates of analysis, CTD/eCTD-aligned dossier support and CDSCO export documentation from the licensed distribution channel. We can align documentation to a specific MoH tender or NGO procurement format on request.
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.