Gemcitabine HCl structure
Human APIs

Gemcitabine HCl

CAS Registry Number: 122111-03-9

Gemcitabine HCl — active pharmaceutical ingredient (API) manufactured to pharmacopoeial specification. Purity ≥99.0%. CAS Registry Number: 122111-03-9. Supplied in bulk quantities from $2800.00/g entry for laboratory research, analytical me

Product information

Gemcitabine HCl — active pharmaceutical ingredient (API) manufactured to pharmacopoeial specification. Purity ≥99.0%. CAS Registry Number: 122111-03-9. Supplied in bulk quantities from $2800.00/g entry for laboratory research, analytical method development, and reference-standard applications.

Product specifications

CAS Registry Number
122111-03-9
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 Gemcitabine HCl-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 Gemcitabine HCl

What is Gemcitabine HCl used for?

Gemcitabine HCl 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 Gemcitabine HCl typically reference it under CAS Registry Number 122111-03-9.

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

Our Gemcitabine HCl 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 Gemcitabine HCl?

Quote requests for Gemcitabine HCl 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 Gemcitabine HCl to?

We export Gemcitabine HCl 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.