Active Pharmaceutical Ingredient

Clonazepam API Manufacturer & Supplier in India

Also known as: Klonopin, Rivotril (brand)

CAS: 1622-61-3 Benzodiazepine USP / BP / IP Bulk Supply Available
Clonazepam API Manufacturer India | Mediocon Inc
Clonazepam — Pharmaceutical Grade API

Product Overview

CAS No: 1622-61-3  |  MF: C₁₅H₁₀ClN₃O₃  |  MW: 315.71 g/mol

Clonazepam is a long-acting benzodiazepine that enhances the effect of GABA at the GABA-A receptor. It is used as an anticonvulsant for epilepsy and seizure disorders, as an anxiolytic for panic disorder, and as a sedative. Mediocon Inc supplies pharmaceutical-grade Clonazepam meeting IP/BP/EP/USP standards.

Key Features

  • Long-acting benzodiazepine GABA-A enhancer
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Anticonvulsant and anxiolytic properties
  • Suitable for oral tablet and oral disintegrating tablet formulations

Applications

  • Epilepsy and seizure disorder treatment
  • Panic disorder and anxiety therapy
  • Acute mania adjunct treatment
  • Restless leg syndrome 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 NameClonazepam
Also Known AsKlonopin, Rivotril (brand)
CAS Number1622-61-3
Molecular FormulaC₁₅H₁₀ClN₃O₃
Molecular Weight315.71 g/mol
CategoryBenzodiazepine / Anticonvulsant / Anxiolytic
AppearanceLight Yellow Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Related SubstancesComplies
Microbial LimitsComplies with pharmacopoeia
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 Clonazepam (CAS 1622-61-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Clonazepam 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 — Clonazepam API

What is the minimum order quantity for Clonazepam API?
Mediocon Inc supplies Clonazepam 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 Clonazepam does Mediocon supply?
We supply Clonazepam 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 Clonazepam API?
Every shipment of Clonazepam 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 Clonazepam bulk orders?
Standard lead time for Clonazepam 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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