Active Pharmaceutical Ingredient

Acemetacin API Manufacturer & Supplier in India

Also known as: Emflex; Rantudil

CAS: 53164-05-9 Anti-Inflammatory / NSAID (Analgesic) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Acemetacin API — Mediocon Inc
Acemetacin — Pharmaceutical Grade API

Product Overview

CAS No: 53164-05-9  |  MF: C21H18ClNO6  |  MW: 415.82 g/mol

Acemetacin is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Anti-Inflammatory / NSAID (Analgesic) category. Mediocon Inc supplies high-purity Acemetacin API (CAS 53164-05-9) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Acemetacin is primarily associated with: Non-steroidal anti-inflammatory drug (NSAID) — indomethacin ester prodrug. Mediocon's Acemetacin meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

  • High-purity pharmaceutical grade API (NLT 98.0% assay)
  • IP / BP / EP / USP compliant with full analytical verification
  • Full CoA, MSDS/SDS, and COO documentation with every batch
  • GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

  • Osteoarthritis and rheumatoid arthritis pain management
  • Post-operative inflammation and pain relief
  • Musculoskeletal and soft-tissue disorder treatment
  • NSAID generic formulation development

Why Choose Mediocon

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

Product Specifications

Product NameAcemetacin
Also Known AsEmflex; Rantudil
CAS Number53164-05-9
Molecular FormulaC21H18ClNO6
Molecular Weight415.82 g/mol
CategoryAnti-Inflammatory / NSAID (Analgesic)
AppearanceWhite to pale yellow crystalline powder
GradeIP / BP / EP / USP
StorageStore in a cool, dry place; protected from light and moisture

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 Acemetacin (CAS 53164-05-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Acemetacin is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP / BP / EP / USP). 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 — Acemetacin API

What is the minimum order quantity for Acemetacin API?
Mediocon Inc supplies Acemetacin 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 Acemetacin does Mediocon supply?
We supply Acemetacin conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Acemetacin API?
Every shipment of Acemetacin 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 Acemetacin bulk orders?
Standard lead time for Acemetacin is 2-4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging.
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