Tadalafil pharmaceutical API powder — CAS 171596-29-5 — WHO-GMP manufacturer Longshine Boi-Tech, Pune, India
Human APIs

Tadalafil

CAS Registry Number: 171596-29-5

Tadalafil is a long-acting selective PDE5 inhibitor (t1/2 ~17.5 hours) used at 5-20 mg for erectile dysfunction (on-demand and daily dosing), 5 mg daily for benign prostatic hyperplasia (BPH), and 40 mg daily for pulmonary arterial hyperten

Product information

Tadalafil is a long-acting selective PDE5 inhibitor (t1/2 ~17.5 hours) used at 5-20 mg for erectile dysfunction (on-demand and daily dosing), 5 mg daily for benign prostatic hyperplasia (BPH), and 40 mg daily for pulmonary arterial hypertension (PAH, brand name Adcirca). Manufactured to USP and Ph. Eur. monograph specifications with rigorous polymorph and impurity control.

Product specifications

CAS Registry Number
171596-29-5
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 Tadalafil-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 Tadalafil

What is Tadalafil used for?

Tadalafil 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 Tadalafil typically reference it under CAS Registry Number 171596-29-5.

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

Our Tadalafil 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 Tadalafil?

Quote requests for Tadalafil 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 Tadalafil to?

We export Tadalafil 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

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.