Active Pharmaceutical Ingredient

Sildenafil API Manufacturer & Supplier in India

Also known as: Sildenafil Citrate; Viagra API; Revatio API

CAS: 139755-83-2 Vasodilator BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sildenafil API — Mediocon Inc
Sildenafil — Pharmaceutical Grade API

Product Overview

CAS No: 139755-83-2  |  MF: C₂₂H₃₀N₆O₄S  |  MW: 474.58 g/mol

Sildenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor and active pharmaceutical ingredient used in the treatment of erectile dysfunction and pulmonary arterial hypertension (PAH). Mediocon Inc supplies high-purity Sildenafil API conforming to BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sildenafil inhibits PDE5, the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation and increased blood flow. It is a first-line treatment for erectile dysfunction and PAH.

Key Features

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

Applications

  • Erectile dysfunction treatment formulations
  • Pulmonary arterial hypertension (PAH)
  • PDE5 inhibitor oral dosage forms
  • Cardiovascular pharmaceutical research

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 NameSildenafil
Also Known AsSildenafil Citrate; Viagra API; Revatio API
CAS Number139755-83-2
Molecular FormulaC₂₂H₃₀N₆O₄S
Molecular Weight474.58 g/mol
CategoryPDE5 Inhibitor — Vasodilator
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in methanol; slightly soluble in water
GradeBP / 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
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 Sildenafil (CAS 139755-83-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sildenafil 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 — Sildenafil API

What is the minimum order quantity for Sildenafil API?
Mediocon Inc supplies Sildenafil 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 Sildenafil does Mediocon supply?
We supply Sildenafil conforming to 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 Sildenafil API?
Every shipment of Sildenafil 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 Sildenafil bulk orders?
Standard lead time for Sildenafil 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?