Active Pharmaceutical Ingredient

Abaperidone API Manufacturer & Supplier in India

Also known as: FI 8602; Abaperidone Free Base

CAS: 183849-43-6 Psychiatry / Atypical Antipsychotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Abaperidone API — Mediocon Inc
Abaperidone — Pharmaceutical Grade API

Product Overview

CAS No: 183849-43-6  |  MF: C25H25FN2O5  |  MW: 452.47 g/mol

Abaperidone is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Psychiatry / Atypical Antipsychotic category. Mediocon Inc supplies high-purity Abaperidone API (CAS 183849-43-6) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Abaperidone is primarily associated with: Atypical antipsychotic; 5-HT2A / dopamine D2 receptor antagonist. Mediocon's Abaperidone meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

  • High-purity pharmaceutical grade API (NLT 98.0% assay)
  • IP / BP / EP / USP compliant with full analytical verification
  • Full CoA, MSDS/SDS, and COO documentation with every batch
  • GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

  • Investigational atypical antipsychotic for schizophrenia and related disorders
  • 5-HT2A / dopamine D2 receptor antagonist research
  • CNS receptor-binding and pharmacology studies
  • Generic antipsychotic formulation development

Why Choose Mediocon

  • ISO 9001:2015 & WHO-GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF support
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings (FDA, EMA, WHO)

Product Specifications

Product NameAbaperidone
Also Known AsFI 8602; Abaperidone Free Base
CAS Number183849-43-6
Molecular FormulaC25H25FN2O5
Molecular Weight452.47 g/mol
CategoryPsychiatry / Atypical Antipsychotic
AppearanceOff-white to pale yellow crystalline powder
GradeIP / BP / EP / USP
StorageStore in a cool, dry place; protected from light and moisture

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 Abaperidone (CAS 183849-43-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Abaperidone is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP / BP / EP / USP). 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 — Abaperidone API

What is the minimum order quantity for Abaperidone API?
Mediocon Inc supplies Abaperidone 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 Abaperidone does Mediocon supply?
We supply Abaperidone conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Abaperidone API?
Every shipment of Abaperidone 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 Abaperidone bulk orders?
Standard lead time for Abaperidone is 2-4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging.
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