Active Pharmaceutical Ingredient

Risperidone API Manufacturer & Supplier in India

Also known as: Risperdal API; 9-Hydroxyrisperidone precursor

CAS: 106266-06-2 Atypical Antipsychotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Risperidone API — Mediocon Inc
Risperidone — Pharmaceutical Grade API

Product Overview

CAS No: 106266-06-2  |  MF: C₂₃H₂₇FN₄O₂  |  MW: 410.49 g/mol

Risperidone is an atypical antipsychotic active pharmaceutical ingredient used in the management of schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. Mediocon Inc supplies high-purity Risperidone API from our GMP-certified facility in Aurangabad, Maharashtra, India.

Risperidone works by antagonizing dopamine D2 and serotonin 5-HT2A receptors, producing antipsychotic effects with a lower risk of extrapyramidal side effects compared to typical antipsychotics.

Key Features

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

Applications

  • Schizophrenia treatment formulations
  • Bipolar disorder management
  • Autism-related irritability
  • Atypical antipsychotic oral and injectable forms

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 NameRisperidone
Also Known AsRisperdal API; 9-Hydroxyrisperidone precursor
CAS Number106266-06-2
Molecular FormulaC₂₃H₂₇FN₄O₂
Molecular Weight410.49 g/mol
CategoryAtypical Antipsychotic
AppearanceWhite to off-white powder
SolubilityPractically insoluble in water; soluble in methanol, DCM
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 Risperidone (CAS 106266-06-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Risperidone 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 — Risperidone API

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