Active Pharmaceutical Ingredient

Oxybutynin API Manufacturer & Supplier in India

Also known as: Ditropan; Oxytrol

CAS: 5633-20-5 Anticholinergic / Urinary Antispasmodic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Oxybutynin API — Mediocon Inc
Oxybutynin — Pharmaceutical Grade API

Product Overview

CAS No: 5633-20-5  |  MF: C₂₂H₃₁NO₃  |  MW: 357.49 g/mol

Oxybutynin is a pharmaceutical-grade active ingredient classified as Anticholinergic / Urinary Antispasmodic. Mediocon Inc supplies high-purity Oxybutynin API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Oxybutynin is an anticholinergic drug used to treat overactive bladder, urinary incontinence, and bladder spasms by relaxing the detrusor muscle.

Key Features

  • Anticholinergic antispasmodic
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Overactive bladder
  • Urinary incontinence
  • Bladder spasms
  • Hyperhidrosis

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 NameOxybutynin
Also Known AsDitropan; Oxytrol
CAS Number5633-20-5
Molecular FormulaC₂₂H₃₁NO₃
Molecular Weight357.49 g/mol
CategoryAnticholinergic / Urinary Antispasmodic
AppearanceWhite to off-white crystalline powder
SolubilitySoluble 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 Oxybutynin (CAS 5633-20-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Oxybutynin 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 — Oxybutynin API

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