Finasteride pharmaceutical API powder — CAS 98319-26-7 — WHO-GMP manufacturer Longshine Boi-Tech, Pune, India
Human APIs

Finasteride

CAS Registry Number: 98319-26-7

Finasteride is a synthetic type II 5-alpha-reductase inhibitor used at 5 mg for benign prostatic hyperplasia (BPH) and at 1 mg for androgenetic alopecia. Manufactured to USP and Ph. Eur. monograph specifications with tight enantiomeric puri

Product information

Finasteride is a synthetic type II 5-alpha-reductase inhibitor used at 5 mg for benign prostatic hyperplasia (BPH) and at 1 mg for androgenetic alopecia. Manufactured to USP and Ph. Eur. monograph specifications with tight enantiomeric purity control (>99.5% desired isomer) and full impurity profile per ICH Q3A/M7. Longshine Boi-Tech maintains active regulatory filings for generic-drug developers.

Product specifications

CAS Registry Number
98319-26-7
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 Finasteride-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.
View interactive page & request quote Email sales Order a sample

Frequently asked questions about Finasteride

What is Finasteride used for?

Finasteride 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 Finasteride typically reference it under CAS Registry Number 98319-26-7.

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

Our Finasteride 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 Finasteride?

Quote requests for Finasteride 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 Finasteride to?

We export Finasteride 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 Human APIs APIs

Other human apis molecules from Longshine Boi-Tech's WHO-GMP catalogue — each with active regulatory filings, audit-ready CoA, and samples available under CDA.

Fluconazole
CAS 86386-73-4
Simvastatin
CAS 79902-63-9
Ceftazidime Pentahydrate
CAS 72558-82-8
Amoxicillin Trihydrate
CAS 26787-78-0
Salmeterol Xinafoate
CAS 94749-08-3
Terbinafine HCl
CAS 78628-80-5
Artemether
CAS 71963-77-4
Dobutamine HCl
CAS 49745-95-1

Related categories & resources

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