Active Pharmaceutical Ingredient

Nafarelin Acetate API Manufacturer & Supplier

CAS: 86220-42-0 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Nafarelin Acetate API Manufacturer & Supplier — Mediocon Inc
Nafarelin Acetate API Manufacturer & Supplier

Product Overview

CAS No: 86220-42-0 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Nafarelin Acetate API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nafarelin Acetate 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 Acetate is a synthetic gonadotropin-releasing hormone (GnRH) agonist peptide widely used in pharmaceutical formulations for the treatment of endometriosis, central precocious puberty (CPP), uterine fibroids, and infertility-related conditions. It acts by initially stimulating and subsequently suppressing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in decreased production of estrogen and testosterone. Due to its high potency and therapeutic efficacy, Nafarelin Acetate 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 Acetate 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 Acetate API Manufacturer & Supplier
CAS Number86220-42-0
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Lyophilized Powder
StandardsUSP / EP / In-house Pharmaceutical Specifications

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 dilute aqueous buffers

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 Acetate API Manufacturer & Supplier (CAS 86220-42-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nafarelin Acetate 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 Acetate API Manufacturer & Supplier

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