Active Pharmaceutical Ingredient

Alitretinoin API Manufacturer & Supplier in India

Also known as: Toctino

CAS: 5300-03-8 Retinoid / Dermatology BP / EP Bulk Supply Available
Alitretinoin API Manufacturer India | Mediocon Inc
Alitretinoin — Pharmaceutical Grade API

Product Overview

CAS No: 5300-03-8  |  MF: C₂₀H₂₈O₂  |  MW: 300.44 g/mol

Alitretinoin (9-cis-retinoic acid) is a panretinoic acid that binds to all known retinoid receptors. It is used for the treatment of severe chronic hand eczema refractory to topical corticosteroids. Mediocon Inc supplies pharmaceutical-grade Alitretinoin meeting BP and EP standards.

Key Features

  • Pan-retinoid receptor agonist
  • BP/EP compliant quality
  • Effective for chronic hand eczema
  • Licensed capsule formulation API

Applications

  • Severe chronic hand eczema capsules
  • Refractory dermatitis treatment
  • Specialty dermatological formulations
  • Kaposi sarcoma topical gel

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 NameAlitretinoin
Also Known AsToctino
CAS Number5300-03-8
Molecular FormulaC₂₀H₂₈O₂
Molecular Weight300.44 g/mol
CategoryRetinoid / Dermatological Agent
AppearanceYellow to Orange Crystalline Powder
GradeBP / EP

Analytical Specifications

ParameterSpecification
Assay97.0% – 102.0%
Loss on DryingNMT 0.5%
Melting Point189°C – 192°C
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg foil pouches / 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 Alitretinoin (CAS 5300-03-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Alitretinoin 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 — Alitretinoin API

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