Active Pharmaceutical Ingredient

Meropenem API Manufacturer & Supplier in India

Also known as: Merrem

CAS: 119478-56-7 Carbapenem Antibiotic IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Meropenem API — Mediocon Inc
Meropenem — Pharmaceutical Grade API

Product Overview

CAS No: 119478-56-7  |  MF: C₁₇H₂₅N₃O₅S·3H₂O  |  MW: 437.53 g/mol

Meropenem is a pharmaceutical-grade active ingredient classified as Carbapenem Antibiotic. Mediocon Inc supplies high-purity Meropenem API conforming to IP / BP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Broad-spectrum carbapenem antibiotic
  • IP/BP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Severe bacterial infections
  • Hospital-acquired pneumonia
  • Complicated urinary tract infections
  • Bacterial meningitis treatment

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 NameMeropenem
Also Known AsMerrem
CAS Number119478-56-7
Chemical NameMeropenem Trihydrate
Molecular FormulaC₁₇H₂₅N₃O₅S·3H₂O
Molecular Weight437.53 g/mol
CategoryCarbapenem Antibiotic
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; slightly soluble in methanol
GradeIP / BP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 97.0%
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 Meropenem (CAS 119478-56-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Meropenem 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 — Meropenem API

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