Active Pharmaceutical Ingredient

Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 207844-01-7 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 207844-01-7 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Mitiglinide API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mitiglinide API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, antidiabetic 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.

Mitiglinide is a rapid-acting insulin secretagogue and oral antidiabetic active pharmaceutical ingredient widely used in pharmaceutical formulations for the management of Type 2 Diabetes Mellitus. It belongs to the meglitinide class of antidiabetic agents and works by selectively binding to ATP-sensitive potassium (K<sub>ATP</sub>) channels on pancreatic β-cells, stimulating insulin secretion in response to meals. Its rapid onset and short duration of action make Mitiglinide particularly effective in controlling postprandial (post-meal) blood glucose levels while reducing the risk of prolonged hypoglycemia. Owing to its excellent therapeutic profile, Mitiglinide is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

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

Product Specifications

Product NameMitiglinide API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number207844-01-7
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point175°C – 180°C
SolubilitySlightly soluble in water; freely soluble in methanol and ethanol

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 Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC (CAS 207844-01-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC 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 — Mitiglinide API Manufacturer & Supplier in India | MEDIOCON INC

What is Mitiglinide API?
Mitiglinide API is a rapid-acting oral antidiabetic active pharmaceutical ingredient belonging to the meglitinide class, used for the management of Type 2 Diabetes Mellitus.
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