Active Pharmaceutical Ingredient

Solifenacin API Manufacturer & Supplier in India

Also known as: Solifenacin Succinate; VESIcare; Vesicare LS

CAS: 242478-37-1 Muscarinic Antagonist IP / BP / EP / USP / INH / FCC / NF GMP Certified Aurangabad, Maharashtra, India
Solifenacin API — Mediocon Inc
Solifenacin — Pharmaceutical Grade API

Product Overview

CAS No: 242478-37-1  |  MF: C₂₃H₂₆N₂O₂·C₄H₆O₄  |  MW: 480.55 g/mol

Solifenacin (as Solifenacin Succinate) is a selective M3 muscarinic receptor antagonist used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Solifenacin API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Solifenacin selectively blocks M3 muscarinic receptors in the bladder detrusor muscle, reducing urinary urgency, frequency, and urge incontinence. It is the leading treatment for overactive bladder (OAB) syndrome.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP / INH / FCC / NF compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Overactive bladder (OAB) treatment
  • Urinary urgency and frequency reduction
  • Urge urinary incontinence
  • Neurogenic bladder 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 NameSolifenacin
Also Known AsSolifenacin Succinate; VESIcare; Vesicare LS
CAS Number242478-37-1
Molecular FormulaC₂₃H₂₆N₂O₂·C₄H₆O₄
Molecular Weight480.55 g/mol
CategoryMuscarinic Antagonist — Urological
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; soluble in methanol
GradeIP / BP / EP / USP / INH / FCC / NF

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 Solifenacin (CAS 242478-37-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Solifenacin 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 — Solifenacin API

What is the minimum order quantity for Solifenacin API?
Mediocon Inc supplies Solifenacin 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 Solifenacin does Mediocon supply?
We supply Solifenacin conforming to IP / BP / EP / USP / INH / FCC / NF 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 Solifenacin API?
Every shipment of Solifenacin 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 Solifenacin bulk orders?
Standard lead time for Solifenacin 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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