Active Pharmaceutical Ingredient

Mibefradil API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 116644-53-2 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mibefradil API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mibefradil API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 116644-53-2 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Mibefradil API Manufacturer & Supplier in India

MEDIOCON INC is a trusted global manufacturer and supplier of Mibefradil API in India, offering high-quality pharmaceutical-grade and research-grade active pharmaceutical ingredients for pharmaceutical research, formulation development, analytical testing, quality control, medicinal chemistry, stability studies, and related pharmaceutical applications. Our APIs are supplied with appropriate quality documentation to support pharmaceutical development and research requirements.

Mibefradil is a T-type calcium channel blocker belonging to the calcium channel blocker class. It selectively inhibits T-type calcium channels and has been investigated for its cardiovascular pharmacological properties, including antihypertensive and antianginal activity. Mibefradil was previously marketed for the treatment of hypertension and chronic stable angina, but it was withdrawn from the U.S. market in 1998 because of clinically significant drug-interaction concerns.

Mibefradil is chemically identified as a benzimidazole-substituted tetraline derivative. The free compound has the molecular formula C₂₉H₃₈FN₃O₃, CAS Number 116644-53-2, and molecular weight approximately 495.63 g/mol. The commonly encountered pharmaceutical salt is Mibefradil Dihydrochloride, which is associated with CAS Number 116666-63-8.

Mibefradil has been utilized in calcium-channel pharmacology research, cardiovascular drug research, medicinal chemistry, analytical method development, receptor and ion-channel studies, and pharmaceutical development programs. MEDIOCON INC supplies premium-quality Mibefradil API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), biotechnology companies, universities, research institutes, and analytical laboratories worldwide, supported with comprehensive documentation including COA, MSDS/SDS, technical data sheets, analytical documentation, and applicable product specifications.

Product Specifications

Product NameMibefradil API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number116644-53-2
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite Crystalline Powder
IdentificationIR / HPLC / LC-MS Complies
Assay (HPLC)NLT 98.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.5%
Heavy MetalsNMT 20 ppm
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 1.0%
Melting Point128°C
SolubilityMibefradil Dihydrochloride is reported as water soluble

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 Mibefradil API Manufacturer & Supplier in India | MEDIOCON INC (CAS 116644-53-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

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

What is Mibefradil API?
Mibefradil is a T-type calcium channel blocker that selectively inhibits T-type calcium channels and has been investigated for cardiovascular and calcium-channel pharmacology applications.
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