Active Pharmaceutical Ingredient

Buprenorphine

Also known as: Subutex, Belbuca (brand)

CAS: 52485-79-7 Opioid Partial Agonist USP / BP / IP Bulk Supply Available
Buprenorphine API Manufacturer India | Mediocon Inc
Buprenorphine — Pharmaceutical Grade API

Product Overview

CAS No: 52485-79-7  |  MF: C₂₉H₄₁NO₄  |  MW: 467.64 g/mol

Buprenorphine is a partial opioid agonist used for the treatment of opioid use disorder, moderate-to-severe chronic pain, and as an analgesic. Its ceiling effect on respiratory depression makes it safer than full opioid agonists. Mediocon Inc supplies pharmaceutical-grade Buprenorphine meeting IP/BP/EP/USP standards.

Key Features

  • Partial opioid mu-receptor agonist
  • IP/BP/EP/USP compliant quality
  • Opioid use disorder and pain management
  • Suitable for sublingual, transdermal, and injectable formulations

Applications

  • Sublingual tablets for opioid dependence
  • Transdermal patches for pain
  • Injectable formulations
  • Buccal films and strips

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 NameBuprenorphine
Also Known AsSubutex, Belbuca (brand)
CAS Number52485-79-7
Molecular FormulaC₂₉H₄₁NO₄
Molecular Weight467.64 g/mol
CategoryAnalgesic / Opioid Partial Agonist
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay97.0% – 103.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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