Active Pharmaceutical Ingredient

Methylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 53-36-1 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Methylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Methylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 53-36-1 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Methylprednisolone Acetate API Manufacturer & Supplier in India

MEDIOCON INC is a trusted global Methylprednisolone Acetate API Manufacturer & Supplier in India, offering pharmaceutical-grade active pharmaceutical ingredient information and technical support for pharmaceutical manufacturing, corticosteroid formulation development, analytical testing, quality control, stability studies, and research applications. Methylprednisolone Acetate is a synthetic glucocorticoid and corticosteroid API used for its potent anti-inflammatory and immunosuppressive properties.

Methylprednisolone Acetate is the 21-acetate ester of methylprednisolone and belongs to the synthetic glucocorticoid class. It is chemically identified as Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6α,11β)-. It has the molecular formula C₂₄H₃₂O₆, molecular weight 416.51 g/mol, and CAS Number 53-36-1. The USP monograph specifies Methylprednisolone Acetate at 97.0%–103.0%, calculated on the dried basis.

MEDIOCON INC provides Methylprednisolone Acetate API-related technical and quality information to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), analytical laboratories, research organizations, and other qualified pharmaceutical industry users, with applicable documentation including COA, MSDS/SDS, Technical Data Sheet (TDS), analytical information, and product specifications.

Product Specifications

Product NameMethylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number53-36-1
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to practically white crystalline powder or lumps
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to practically white crystalline powder or lumps
Assay (HPLC)97.0% – 103.0%
Loss on DryingNMT 1.0%,
Residue on IgnitionNMT 0.20%.
Individual ImpurityNMT 1.0%
Total ImpuritiesNMT 2.0%
Water ContentNMT 1.0%.
Specific Rotation+97° to +105°
Melting Point213°C – 215°C

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 Methylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 53-36-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Methylprednisolone Acetate 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 — Methylprednisolone Acetate API Manufacturer & Supplier in India | MEDIOCON INC

What is Methylprednisolone Acetate API?
Methylprednisolone Acetate API is a synthetic glucocorticoid corticosteroid and the acetate ester of methylprednisolone. It is used for its anti-inflammatory and immunosuppressive properties.
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