Active Pharmaceutical Ingredient

Posaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 171228-49-2 Active Pharmaceutical Ingredient USP / EP / BP / IP GMP Certified Aurangabad, Maharashtra, India
Posaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Posaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 171228-49-2 | Grade: USP / EP / BP / IP | Category: Active Pharmaceutical Ingredient

Posaconazole API Manufacturer & Bulk Supplier

Posaconazole API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of broad-spectrum antifungal medications. Posaconazole is a second-generation triazole antifungal agent indicated for the prevention and treatment of invasive aspergillosis, invasive candidiasis, mucormycosis, and other serious fungal infections, particularly in immunocompromised patients. It acts by inhibiting fungal 14α-demethylase (CYP51), disrupting ergosterol biosynthesis and compromising fungal cell membrane integrity. Its exceptional purity, excellent chemical stability, and consistent batch-to-batch quality make it ideal for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research applications.

MEDIOCON INC is a trusted Posaconazole API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities utilize advanced production technologies and stringent quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical quality standards.

Every batch of Posaconazole API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are thoroughly evaluated before commercial release to ensure compliance with stringent pharmaceutical specifications.

Our Posaconazole API is available in USP, EP, BP, IP, and Pharmaceutical Grade, making it suitable for oral suspension formulations, delayed-release tablets, injectable formulations, analytical testing, formulation development, quality control laboratories, stability studies, pharmaceutical process validation, and antifungal pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring smooth procurement and regulatory compliance.

With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and dedicated technical support, we ensure reliable worldwide delivery of premium-quality Posaconazole API.

If you are looking for a trusted Posaconazole API manufacturer, exporter, and bulk supplier, MEDIOCON INC provides pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.

Product Specifications

Product NamePosaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number171228-49-2
CategoryActive Pharmaceutical Ingredient
GradeUSP / EP / BP / IP
AppearanceWhite to Off-White Crystalline Powder
StandardsUSP / EP / BP / IP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, HPLC & UV Complies
Assay (HPLC)99.0% – 101.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.5 – 7.0
Individual ImpurityNMT 0.2%
Total ImpuritiesNMT 1.0%
Water ContentNMT 0.5%
Specific Rotation−28° to −34° (c = 1, Methanol)
Melting Point170°C – 174°C
SolubilityPractically Insoluble in Water; Soluble in Methanol, Ethanol and Dimethyl Sulfoxide (DMSO)−28° to −34° (c = 1, Methanol)

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 Posaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 171228-49-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Posaconazole API Manufacturer & Bulk 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 — Posaconazole API Manufacturer & Bulk Supplier in India | MEDIOCON INC

What is Posaconazole API used for?
Posaconazole API is used in pharmaceutical formulations for the prevention and treatment of invasive fungal infections, including aspergillosis, candidiasis, mucormycosis, and other systemic mycoses.
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