Abiraterone, Indian WHO-GMP supply for metastatic prostate cancer therapy.
Abiraterone acetate is an oral therapy for metastatic prostate cancer, used together with prednisone or prednisolone. M Care sources it from WHO-GMP certified Indian manufacturers and exports to hospital pharmacies, importers, and tender desks outside India.
Abiraterone Acetate exporter and bulk supplier from India.
Abiraterone acetate reached the WHO Essential Medicines List in 2019, and EML-listed medicines are commonly prioritised in national cancer-treatment procurement lists. Generic access to abiraterone opened in stages rather than all at once: US supply followed the 2018 patent invalidation, while EU regulatory exclusivity ran through September 2022, so the pool of eligible manufacturers and the terms of supply differ by destination market. We work with buyers to confirm the current documentation and registration status relevant to their market before committing to volume.
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.
Oral tablet, WHO EML-listed (21st list, July 2019); full documentation pack available on request.
Active ingredient
Abiraterone acetate. CYP17 inhibitor (hormonal antineoplastic agent).
Forms and strengths
Tablet.
Indications
Abiraterone acetate is an oral CYP17 inhibitor used with prednisone or prednisolone in the management of metastatic prostate cancer. It must be taken on an empty stomach, as food materially increases drug exposure. It was added to the WHO Essential Medicines List in the 21st list, published July 2019.
Storage and handling
Oral tablet, WHO EML-listed (21st list, July 2019); full documentation pack available on request.
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.
We supply abiraterone acetate to hospital oncology pharmacies, government and NGO procurement desks running cancer-treatment programmes, and importers and distributors handling oncology portfolios in the Gulf, Africa, UK/EU, SE Asia, and LATAM. Buyers typically approach us once a national or institutional formulary has listed the molecule and a procurement route to Indian generic supply is needed.
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 abiraterone acetate.
Abiraterone acetate is dispensed with prednisone or prednisolone as part of metastatic prostate cancer management. The label requirement that matters most at the counselling stage is administration on an empty stomach: taking abiraterone with food materially increases drug exposure, so patients need clear, repeated instruction on timing relative to meals, not a one-time mention.
Pharmacologically, abiraterone acts as a CYP17 inhibitor, a hormonal agent rather than a classical cytotoxic. That distinction is relevant to how the product is handled and stored in the pharmacy, and it should be communicated accurately to buyers who default to cytotoxic-handling assumptions for all oncology molecules.
We do not supply abiraterone as a finished retail pack for direct patient sale; our role is bulk export to licensed institutional and distributor buyers who manage patient-facing dispensing and counselling themselves.
The documentation pack a regulator actually asks for.
Every abiraterone shipment is backed by manufacturing and quality documentation from the WHO-GMP certified facility of origin, including certificates of analysis and batch-specific records, assembled to match the import and registration requirements of the destination market. We coordinate the document pack with the buyer's regulatory team before shipment rather than issuing a generic template.
Because generic eligibility for abiraterone differs by market and by date (US supply following the 2018 patent decision, EU exclusivity running to September 2022), we confirm the applicable registration pathway and any market-specific restrictions with the buyer at enquiry stage rather than assuming a single global timeline applies.
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 abiraterone acetate.
Docetaxel
Another oral/IV oncology molecule sourced from the same WHO-GMP manufacturer network.
Bortezomib
WHO EML-listed oncology agent with a comparable documentation pack.
Letrozole
Hormonal oncology therapy with similar procurement and export handling.
Oncology category hub
Browse the full range of oncology molecules M Care sources for export.
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 abiraterone acetate.
- 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.
Abiraterone Acetate supply, the specific questions.
Is abiraterone acetate available for bulk export from India?
Yes. We source abiraterone acetate from WHO-GMP certified Indian manufacturers for bulk export to hospital pharmacies, distributors, and tender buyers outside India.
Does M Care manufacture abiraterone itself?
No. M Care is a merchant exporter, not a manufacturer. We source abiraterone from WHO-GMP certified Indian manufacturing partners and manage export, documentation, and logistics.
What documentation is provided with an abiraterone shipment?
Manufacturing and quality documentation from the certified facility of origin, including certificates of analysis and batch records, assembled to match the destination market's import requirements.
Is abiraterone acetate listed on the WHO Essential Medicines List?
Yes. Abiraterone was added to the WHO EML in the 21st list, published July 2019.
Are there market-specific restrictions on sourcing generic abiraterone?
Generic access to abiraterone opened in stages by market rather than uniformly: US supply followed the 2018 patent invalidation, while EU regulatory exclusivity ran through September 2022. We confirm the applicable pathway for the buyer's market at enquiry stage.
What should buyers know about abiraterone's administration requirements?
Abiraterone must be taken on an empty stomach, since food materially increases drug exposure. This is a firm labelling requirement that buyers managing patient-facing dispensing should factor into counselling materials.
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.