Active Pharmaceutical Ingredient

Vardenafil API Manufacturer & Supplier in India

Also known as: Levitra; Staxyn; ZK 100440

CAS: 224785-91-5 PDE5 Inhibitor API IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Vardenafil API — Mediocon Inc
Vardenafil — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 224785-91-5  |  MF: C₂₃H₃₂N₆O₄S·3H₂O  |  MW: 579.63 g/mol

Vardenafil is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Vardenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor used in the treatment of erectile dysfunction (ED). By inhibiting PDE5, it prevents the breakdown of cyclic GMP in smooth muscle cells of the corpus cavernosum, promoting vasodilation and facilitating penile erection in response to sexual stimulation. It is also investigated for pulmonary arterial hypertension.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Erectile dysfunction (ED) treatment
  • Pulmonary arterial hypertension research
  • PDE5 inhibitor pharmaceutical formulations
  • Sexual dysfunction drug development

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameVardenafil
Also Known AsLevitra; Staxyn; ZK 100440
CAS Number224785-91-5
Molecular FormulaC₂₃H₃₂N₆O₄S·3H₂O
Molecular Weight579.63 g/mol
Chemical Name(2S)-2-[4-Ethoxy-3-[4-(2-pyrimidinyl)-1-piperazinyl]sulfonylphenyl]-1-methyl-5-propyl-7H-pyrrolo[2,3-d]pyrimidin-7-one trihydrate
CategoryPDE5 Inhibitor / Erectile Dysfunction Agent
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in methanol and DMSO
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.VDF/24033052
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Vardenafil (CAS 224785-91-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Vardenafil is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Vardenafil API

What is the minimum order quantity for Vardenafil API?
Mediocon Inc supplies Vardenafil with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Vardenafil does Mediocon supply?
We supply Vardenafil conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Vardenafil API?
Every shipment of Vardenafil comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Vardenafil bulk orders?
Standard lead time for Vardenafil is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
💬
Mediocon AI
Hello 👋 How can I help you today?