Active Pharmaceutical Ingredient

Norelgestromin API Manufacturer & Bulk Supplier in India

CAS: 53016-31-2 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Norelgestromin API Manufacturer & Bulk Supplier in India — Mediocon Inc
Norelgestromin API Manufacturer & Bulk Supplier in India

Product Overview

CAS No: 53016-31-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Norelgestromin API Manufacturer & Supplier

MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Norelgestromin API (Active Pharmaceutical Ingredient), offering premium pharmaceutical-grade raw material for formulation development, commercial pharmaceutical manufacturing, analytical testing, quality control laboratories, stability studies, and authorized pharmaceutical research applications. MEDIOCON INC manufactures Norelgestromin API under stringent quality management systems to ensure exceptional purity, batch-to-batch consistency, and compliance with international pharmaceutical standards.

Norelgestromin is a synthetic progestin active pharmaceutical ingredient widely used in hormonal contraceptive formulations, particularly transdermal patches designed for the prevention of pregnancy. The API is extensively utilized in pharmaceutical formulation development, analytical method validation, process optimization, stability studies, hormone therapy research, and quality control applications. MEDIOCON INC supplies high-quality Norelgestromin API that meets stringent pharmaceutical quality standards for domestic and international pharmaceutical markets.

Every production batch manufactured by MEDIOCON INC undergoes comprehensive quality testing including identification, HPLC assay, impurity profiling, water content determination, heavy metal analysis, residual solvent evaluation, and other critical quality assessments. This rigorous quality assurance program ensures excellent pharmaceutical performance, product stability, and batch-to-batch consistency.

MEDIOCON INC supplies Norelgestromin API to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), research laboratories, healthcare institutions, and distributors across domestic and international markets. We provide competitive pricing, dependable bulk supply, worldwide logistics support, and complete regulatory documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting quality documents upon request.

Whether your organization requires Norelgestromin API for commercial manufacturing, hormonal formulation development, analytical testing, validation studies, or pharmaceutical research, MEDIOCON INC is committed to delivering premium-quality pharmaceutical ingredients backed by professional technical support and reliable global supply.

Product Specifications

Product NameNorelgestromin API Manufacturer & Bulk Supplier in India
CAS Number53016-31-2
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR & HPLC Complies
Assay (HPLC)98.5% – 101.5%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 0.5%
Specific Rotation+35° to +45°
Melting Point205°C – 210°C
SolubilitySoluble in Methanol and Acetone; Practically Insoluble in Water

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 Norelgestromin API Manufacturer & Bulk Supplier in India (CAS 53016-31-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Norelgestromin API Manufacturer & Bulk Supplier in India 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 — Norelgestromin API Manufacturer & Bulk Supplier in India

What is Norelgestromin API used for?
Norelgestromin API is widely used in hormonal contraceptive formulations, particularly transdermal contraceptive patches, as well as pharmaceutical formulation development and hormone-related research.
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