Olaparib pharmaceutical API powder — CAS 763113-22-0 — WHO-GMP manufacturer Longshine Boi-Tech, Pune, India
Human APIs

Olaparib

CAS Registry Number: 763113-22-0

Olaparib is a poly(ADP-ribose) polymerase (PARP) inhibitor used in the treatment of BRCA-mutant ovarian, breast, prostate, and pancreatic cancers. Longshine Boi-Tech manufactures Olaparib API to WHO-GMP and ISO 9001:2015 standards in Pune,

Product information

Olaparib is a poly(ADP-ribose) polymerase (PARP) inhibitor used in the treatment of BRCA-mutant ovarian, breast, prostate, and pancreatic cancers. Longshine Boi-Tech manufactures Olaparib API to WHO-GMP and ISO 9001:2015 standards in Pune, India. US FDA DMF available for ANDA referencing; EDQM CEP supplied for EU filings. Full impurity profile per ICH Q3A/Q3B/Q3C/Q3D.

Product specifications

CAS Registry Number
763113-22-0
Therapeutic Category
Human APIs
API Technology
Synthetic / Semi-synthetic (per molecule)
Development Status
Commercial — stocked
Manufacturer
Longshine Boi-Tech Pvt. Ltd.
Facility
Pune, Maharashtra, India 411001

Regulatory filings & documentation

We maintain regulatory dossiers in the following jurisdictions for Olaparib-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.

US FDA DMF (Type II)
EDQM CEP (where applicable)
Brazil ANVISA
Canada Health Canada
Japan PMDA
Korea MFDS
GCC SFDA
EU CEP
WHO-GMP & ISO 9001:2015 certified. US FDA Drug Master File available. EDQM CEP supplied for EU procurement. Pharmacopoeial release against USP, Ph. Eur., IP, JP. CoA on every batch. First-shipment lead time 7-10 business days for stocked APIs.
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Frequently asked questions about Olaparib

What is Olaparib used for?

Olaparib is supplied as a pharmaceutical-grade human apis for use by regulated pharmaceutical manufacturers, contract development and manufacturing organisations (CDMOs), and research institutions. Buyers using Olaparib typically reference it under CAS Registry Number 763113-22-0.

What quality and regulatory standards does Longshine Boi-Tech's Olaparib meet?

Our Olaparib is manufactured under WHO-GMP and ISO 9001:2015 conditions in Pune, India. Per-batch Certificate of Analysis (CoA) is released against USP / Ph. Eur. / IP / JP specifications depending on destination market. We hold US FDA Drug Master File and EDQM Certificate of Suitability dossiers for the molecules where regulatory recognition is required; Letter of Authorization (LoA) is issued at no charge to qualified buyers.

How do I request a quote, sample, or proforma invoice for Olaparib?

Quote requests for Olaparib are turned around within 24 business hours (IST, Pune). Bulk APIs typically ship within 7-10 business days of confirmed PO; air freight to North America and Europe runs 4-5 days door-to-door. Sample agreements are signed before shipping QC-grade material to your formulation laboratory.

Which countries does Longshine Boi-Tech supply Olaparib to?

We export Olaparib to 50+ countries including the United States, Canada, Mexico, Brazil, the European Union, the United Kingdom, Japan, Australia, South Korea, the GCC and across South-East Asia. All regulatory documents (DMF / CEP / LoA) and shipping incoterms (EXW, FCA, CIP, DAP, DDP) are negotiated per buyer.

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Related categories & resources

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