Osimertinib Mesylate structure
Human APIs

Osimertinib Mesylate

CAS Registry Number: 1421373-66-1

Osimertinib Mesylate — active pharmaceutical ingredient (API) manufactured to pharmacopoeial specification. Purity ≥99.0%. CAS Registry Number: 1421373-66-1. Supplied in bulk quantities from $220000.00/g entry for laboratory research, analy

Product information

Osimertinib Mesylate — active pharmaceutical ingredient (API) manufactured to pharmacopoeial specification. Purity ≥99.0%. CAS Registry Number: 1421373-66-1. Supplied in bulk quantities from $220000.00/g entry for laboratory research, analytical method development, and reference-standard applications.

Product specifications

CAS Registry Number
1421373-66-1
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 Osimertinib Mesylate-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 Osimertinib Mesylate

What is Osimertinib Mesylate used for?

Osimertinib Mesylate 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 Osimertinib Mesylate typically reference it under CAS Registry Number 1421373-66-1.

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

Our Osimertinib Mesylate 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 Osimertinib Mesylate?

Quote requests for Osimertinib Mesylate 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 Osimertinib Mesylate to?

We export Osimertinib Mesylate 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.

Related categories

Browse our Human APIs catalogue or the full 560+ product directory. Reference documents: certifications portfolio · quality system · FDA DMF buyer guide · EU CEP supplier guide.