Active Pharmaceutical Ingredient

Nifedipine Manufacturer & Supplier in India

Also known as: Adalat; Procardia; Bay a 1040

CAS: 21829-25-4 Calcium Channel Blocker / Antihypertensive IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nifedipine API — Mediocon Inc
Nifedipine — Pharmaceutical Grade API

Product Overview

CAS No: 21829-25-4  |  MF: C₁₇H₁₈N₂O₆  |  MW: 346.34 g/mol

Nifedipine is a pharmaceutical-grade active ingredient classified as Calcium Channel Blocker / Antihypertensive. Mediocon Inc supplies high-purity Nifedipine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Dihydrofolate reductase inhibitor
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Rheumatoid arthritis
  • Psoriasis
  • Various cancers (ALL, NHL, osteosarcoma)

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 NameNifedipine
Also Known AsAdalat; Procardia; Bay a 1040
CAS Number21829-25-4
Chemical NameNifedipine
Molecular FormulaC₁₇H₁₈N₂O₆
Molecular Weight346.34 g/mol
CategoryCalcium Channel Blocker / Antihypertensive
AppearanceYellow crystalline powder
SolubilityPractically insoluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
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 Nifedipine Manufacturer & (CAS 21829-25-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nifedipine 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 — Nifedipine Manufacturer & API

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