Active Pharmaceutical Ingredient

Amlodipine Manufacturer & Supplier in India

Also known as: Norvasc

CAS: 88150-42-9 Calcium Channel Blocker USP / BP / IP Bulk Supply Available
Amlodipine API Manufacturer India | Mediocon Inc
Amlodipine — Pharmaceutical Grade API

Product Overview

CAS No: 88150-42-9  |  MF: C₂₀H₂₅ClN₂O₅  |  MW: 408.88 g/mol

Amlodipine besylate is a long-acting dihydropyridine calcium channel blocker used for the treatment of hypertension and chronic stable angina. It relaxes vascular smooth muscle resulting in vasodilation. Mediocon Inc supplies pharmaceutical-grade Amlodipine meeting USP, BP, and IP standards.

Key Features

  • Long-acting calcium channel blocker
  • USP/BP/IP compliant quality
  • Effective in hypertension & angina
  • Once-daily dosing formulations

Applications

  • Hypertension tablet formulations
  • Chronic stable angina treatment
  • Combination antihypertensive tablets
  • Coronary artery disease management

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 NameAmlodipine
Also Known AsNorvasc
CAS Number88150-42-9
Molecular FormulaC₂₀H₂₅ClN₂O₅
Molecular Weight408.88 g/mol
CategoryCalcium Channel Blocker / Antihypertensive
AppearanceWhite to Off-white Crystalline Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay98.5% – 101.5%
Loss on DryingNMT 0.5%
Melting Point178°C – 182°C
Heavy MetalsNMT 10 ppm
pH4.0 – 6.0 (1% solution)
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
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 Amlodipine Manufacturer & (CAS 88150-42-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Amlodipine Manufacturer & 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 — Amlodipine Manufacturer & API

What is the minimum order quantity for Amlodipine Manufacturer & API?
Mediocon Inc supplies Amlodipine Manufacturer & 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 Amlodipine Manufacturer & does Mediocon supply?
We supply Amlodipine Manufacturer & conforming to USP / BP / IP 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 Amlodipine Manufacturer & API?
Every shipment of Amlodipine Manufacturer & 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 Amlodipine Manufacturer & bulk orders?
Standard lead time for Amlodipine Manufacturer & 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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