Active Pharmaceutical Ingredient

Procarbazine API Manufacturer & Supplier in India

Also known as: Natulan; MIH; Methylhydrazine

GMP Certified IP / BP / USP Antineoplastic Agent Aurangabad, India
Procarbazine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Procarbazine IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 671-16-9

Product Overview

Procarbazine is an antineoplastic agent used in the treatment of Hodgkin's lymphoma and certain brain tumors. It acts as an alkylating agent and monoamine oxidase (MAO) inhibitor, interfering with DNA, RNA, and protein synthesis. Mediocon Inc manufactures Procarbazine API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment of Hodgkin's lymphoma (MOPP regimen)
  • Management of brain tumors including glioblastoma multiforme
  • Used in BEACOPP chemotherapy protocol
  • Treatment of non-Hodgkin's lymphoma in combination therapy

Technical Specifications

ParameterSpecification
CAS Number671-16-9
Molecular FormulaC12H19N3O
Molecular Weight221.30 g/mol
GradeIP / BP / USP
CategoryAntineoplastic Agent
AppearanceWhite to off-white, crystalline powder
SolubilityFreely soluble in water, sparingly soluble in ethanol, practically insoluble in ether
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPROC/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support

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 Procarbazine — CAS 671-16-9 (CAS 671-16-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Procarbazine — CAS 671-16-9 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 — Procarbazine — CAS 671-16-9 API

What is the minimum order quantity for Procarbazine — CAS 671-16-9 API?
Mediocon Inc supplies Procarbazine — CAS 671-16-9 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 Procarbazine — CAS 671-16-9 does Mediocon supply?
We supply Procarbazine — CAS 671-16-9 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 Procarbazine — CAS 671-16-9 API?
Every shipment of Procarbazine — CAS 671-16-9 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 Procarbazine — CAS 671-16-9 bulk orders?
Standard lead time for Procarbazine — CAS 671-16-9 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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