Active Pharmaceutical Ingredient

Orlistat API Manufacturer & Supplier in India

Also known as: Xenical; Alli

CAS: 96829-58-2 Lipase Inhibitor / Anti-obesity IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Orlistat API — Mediocon Inc
Orlistat — Pharmaceutical Grade API

Product Overview

CAS No: 96829-58-2  |  MF: C₂₉H₅₃NO₅  |  MW: 495.73 g/mol

Orlistat is a pharmaceutical-grade active ingredient classified as Lipase Inhibitor / Anti-obesity. Mediocon Inc supplies high-purity Orlistat API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Orlistat is a gastrointestinal lipase inhibitor used in the management of obesity. It works by blocking the absorption of dietary fats in the intestine, leading to caloric deficit.

Key Features

  • Gastrointestinal lipase inhibitor
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Obesity management
  • Weight loss adjunct
  • Type 2 diabetes prevention
  • Metabolic syndrome

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 NameOrlistat
Also Known AsXenical; Alli
CAS Number96829-58-2
Molecular FormulaC₂₉H₅₃NO₅
Molecular Weight495.73 g/mol
CategoryLipase Inhibitor / Anti-obesity
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble 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 Orlistat (CAS 96829-58-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Orlistat 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 — Orlistat API

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