Active Pharmaceutical Ingredient

Nafarelin API Manufacturer & Supplier

CAS: 76932-56-4 Active Pharmaceutical Ingredient GMP Certified Aurangabad, Maharashtra, India
Nafarelin API Manufacturer & Supplier — Mediocon Inc
Nafarelin API Manufacturer & Supplier

Product Overview

CAS No: 76932-56-4 | Category: Active Pharmaceutical Ingredient

Nafarelin API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nafarelin API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, peptide formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nafarelin is a synthetic gonadotropin-releasing hormone (GnRH) agonist peptide widely used in pharmaceutical formulations for the treatment of endometriosis, central precocious puberty (CPP), infertility management, uterine fibroids, and hormone-dependent disorders. It acts by initially stimulating and subsequently suppressing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in reduced production of estrogen and testosterone. Due to its potent endocrine regulatory activity, Nafarelin is extensively utilized in peptide pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nafarelin API to pharmaceutical manufacturers, peptide formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNafarelin API Manufacturer & Supplier
CAS Number76932-56-4
CategoryActive Pharmaceutical Ingredient
AppearanceWhite to Off-White Lyophilized Powder
StandardsUSP / EP / In-house Specification

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Lyophilized Powder
IdentificationHPLC, Mass Spectrometry & Amino Acid Analysis Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 5.00%
Residue on IgnitionNMT 0.20%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.0 – 6.5
Individual ImpurityNMT 1.00%
Total ImpuritiesNMT 2.00%
Water ContentNMT 5.00%
Melting Point2°C to 8°C
SolubilityFreely soluble in water and aqueous buffer solutions

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 Nafarelin API Manufacturer & Supplier (CAS 76932-56-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nafarelin API Manufacturer & Supplier 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 — Nafarelin API Manufacturer & Supplier

What is Nafarelin API?
Nafarelin API is a synthetic gonadotropin-releasing hormone (GnRH) agonist peptide used in pharmaceutical formulations for hormone-related disorders and reproductive health therapies.
💬
Mediocon AI
Hello 👋 How can I help you today?