Active Pharmaceutical Ingredient

Acitretin API Manufacturer & Supplier in India

Also known as: Neotigason

CAS: 55079-83-9 Retinoid / Dermatology USP / BP Bulk Supply Available
Acitretin API Manufacturer India | Mediocon Inc
Acitretin — Pharmaceutical Grade API

Product Overview

CAS No: 55079-83-9  |  MF: C₂₁H₂₆O₃  |  MW: 326.43 g/mol

Acitretin is a synthetic retinoid used primarily in the treatment of severe psoriasis and other dermatological disorders. It modulates keratinocyte differentiation and proliferation. Mediocon Inc supplies pharmaceutical-grade Acitretin meeting USP and BP standards.

Key Features

  • Potent retinoid for severe psoriasis
  • USP/BP compliant quality
  • Modulates keratinocyte differentiation
  • Used in specialist dermatology formulations

Applications

  • Severe plaque psoriasis capsules
  • Palmoplantar pustulosis treatment
  • Dermatological specialty formulations
  • Congenital ichthyosis treatment

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 NameAcitretin
Also Known AsNeotigason
CAS Number55079-83-9
Molecular FormulaC₂₁H₂₆O₃
Molecular Weight326.43 g/mol
CategoryRetinoid / Dermatological Agent
AppearanceYellow to Orange Crystalline Powder
GradeUSP / BP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Melting Point228°C – 230°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 Acitretin (CAS 55079-83-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Acitretin 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 — Acitretin API

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