Active Pharmaceutical Ingredient

Flunarizine API Manufacturer & Supplier in India

Also known as: Sibelium (brand)

CAS: 52468-60-7 Calcium Channel Blocker / Antimigraine IP / BP / USP Bulk Supply Available
Flunarizine API Manufacturer India | Mediocon Inc
Flunarizine — Pharmaceutical Grade API

Product Overview

CAS No: 52468-60-7  |  MF: C₂₆H₂₆F₂N₂  |  MW: 404.50 g/mol

Flunarizine is a selective calcium entry blocker used for the prophylactic treatment of migraine, vertigo, and peripheral vascular disease. It blocks voltage-dependent calcium channels and exhibits antihistaminic and dopamine D2 receptor blocking properties.

Mediocon Inc supplies Flunarizine IP/BP/USP as a pharmaceutical-grade API for manufacturers producing antimigraine and neurological formulations. With robust quality controls and GMP-certified manufacturing, we ensure consistent purity and efficacy in every batch.

Key Features

  • Selective calcium channel blocker
  • Antimigraine & antivertigo action
  • Dopamine D2 antagonist activity
  • Stable shelf life with proper storage

Applications

  • Migraine prophylaxis tablets & capsules
  • Vertigo treatment formulations
  • Peripheral vascular disease therapy
  • Neurological & CNS product manufacturing

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameFlunarizine
CAS Number52468-60-7
Molecular FormulaC₂₆H₂₆F₂N₂
Molecular Weight404.50 g/mol
CategoryCalcium Channel Blocker / Antimigraine
AppearanceWhite to Off-White Powder
GradeIP / BP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 98.0% & NMT 102.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 10 ppm
Residual SolventsComplies ICH Q3C
Microbial LimitsComplies
IdentificationHPLC & IR Compliant
Melting Point252 – 256 °C
Packing25 kg HDPE drums / as per requirement

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 Flunarizine (CAS 52468-60-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Flunarizine 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Flunarizine API

What is the minimum order quantity for Flunarizine API?
Mediocon Inc supplies Flunarizine with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Flunarizine does Mediocon supply?
We supply Flunarizine conforming to IP / BP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Flunarizine API?
Every shipment of Flunarizine comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Flunarizine bulk orders?
Standard lead time for Flunarizine is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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