Vardenafil Hydrochloride Trihydrate structure
Human APIs

Vardenafil Hydrochloride Trihydrate

CAS Registry Number: 224785-91-5

Vardenafil Hydrochloride Trihydrate is a selective PDE5 inhibitor used at 5-20 mg for erectile dysfunction, with somewhat higher receptor selectivity than sildenafil. Manufactured to USP specifications as the hydrochloride trihydrate salt (

Product information

Vardenafil Hydrochloride Trihydrate is a selective PDE5 inhibitor used at 5-20 mg for erectile dysfunction, with somewhat higher receptor selectivity than sildenafil. Manufactured to USP specifications as the hydrochloride trihydrate salt (verifiable via Karl Fischer moisture content of 8.1-9.0%), with full impurity and polymorph documentation.

Product specifications

CAS Registry Number
224785-91-5
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 Vardenafil Hydrochloride Trihydrate-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 Vardenafil Hydrochloride Trihydrate

What is Vardenafil Hydrochloride Trihydrate used for?

Vardenafil Hydrochloride Trihydrate 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 Vardenafil Hydrochloride Trihydrate typically reference it under CAS Registry Number 224785-91-5.

What quality and regulatory standards does Longshine Boi-Tech's Vardenafil Hydrochloride Trihydrate meet?

Our Vardenafil Hydrochloride Trihydrate 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 Vardenafil Hydrochloride Trihydrate?

Quote requests for Vardenafil Hydrochloride Trihydrate 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 Vardenafil Hydrochloride Trihydrate to?

We export Vardenafil Hydrochloride Trihydrate 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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