Active Pharmaceutical Ingredient

Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 862189-95-5 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 862189-95-5 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Mirodenafil API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mirodenafil API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Mirodenafil is a potent phosphodiesterase type 5 (PDE5) inhibitor active pharmaceutical ingredient widely used in pharmaceutical formulations for the treatment of erectile dysfunction (ED). It selectively inhibits the PDE5 enzyme, preventing the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. This results in smooth muscle relaxation, increased penile blood flow, and improved erectile function during sexual stimulation. Mirodenafil is recognized for its rapid onset of action, high selectivity for PDE5, and favorable pharmacokinetic profile. It is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Mirodenafil API across India and to global pharmaceutical manufacturers, formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents are available upon request.

Product Specifications

Product NameMirodenafil API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number862189-95-5
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.5 – 7.0
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point185°C – 195°C
SolubilitySlightly soluble in water; freely soluble in methanol and dimethyl sulfoxide (DMSO)

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 Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC (CAS 862189-95-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Mirodenafil API Manufacturer & Supplier in India | MEDIOCON INC

What is Mirodenafil API?
Mirodenafil API is a phosphodiesterase type 5 (PDE5) inhibitor active pharmaceutical ingredient used in pharmaceutical formulations for the treatment of erectile dysfunction.
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