Active Pharmaceutical Ingredient

Paliperidone (CAS 144598-75-4) API Manufacturer & Supplier in India

Also known as: Invega; 9-Hydroxyrisperidone

CAS: 144598-75-4 Atypical Antipsychotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Paliperidone API — Mediocon Inc
Paliperidone — Pharmaceutical Grade API

Product Overview

CAS No: 144598-75-4  |  MF: C₂₃H₂₇FN₄O₃  |  MW: 426.49 g/mol

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

Paliperidone (9-hydroxyrisperidone) is the primary active metabolite of risperidone. It is a dopamine D2 and serotonin 5-HT2A receptor antagonist used in the treatment of schizophrenia and schizoaffective disorder.

Key Features

  • Dopamine D2 / Serotonin 5-HT2A antagonist
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Schizophrenia
  • Schizoaffective disorder
  • Acute psychotic episodes
  • Bipolar I disorder (adjunctive)

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 NamePaliperidone
Also Known AsInvega; 9-Hydroxyrisperidone
CAS Number144598-75-4
Molecular FormulaC₂₃H₂₇FN₄O₃
Molecular Weight426.49 g/mol
CategoryAtypical Antipsychotic
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in methanol; sparingly soluble in ethanol
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 Paliperidone (CAS 144598-75-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Paliperidone 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 — Paliperidone API

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