Active Pharmaceutical Ingredient

Ergometrine Maleate API Manufacturer & Supplier in India

High-purity Ergometrine Maleate API — GMP Certified

CAS: 129-51-1 IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Ergometrine Maleate API Manufacturer In India — Mediocon Inc
Ergometrine Maleate API Manufacturer In India — Pharmaceutical Grade API

Product Overview

CAS No: 129-51-1  |  MF: C19H23N3O2·C4H4O4  |  MW: 441.48

Ergometrine Maleate (Ergonovine Maleate) is an ergot alkaloid with potent oxytocic and vasoconstrictor properties, used to prevent and treat postpartum haemorrhage. Mediocon Inc manufactures Ergometrine Maleate API to IP/BP/EP/USP pharmacopoeial standards in its GMP-certified facility in Aurangabad, Maharashtra, India.

Our Ergometrine Maleate API is supplied to injectable and oral obstetric pharmaceutical manufacturers globally. Full quality documentation and regulatory support is provided for all markets.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Postpartum haemorrhage prevention and treatment
  • Obstetric injectable and oral formulations
  • Oxytocic pharmaceutical manufacturing
  • Uterine contraction induction therapy

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 NameErgometrine Maleate
CAS Number129-51-1
Molecular FormulaC19H23N3O2·C4H4O4
Molecular Weight441.48
CategoryActive Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoPEMD/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Quantity25.00 Kg
Gross Weight26.00 Kg

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 Ergometrine Maleate (CAS 129-51-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ergometrine Maleate 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 — Ergometrine Maleate API

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