Active Pharmaceutical Ingredient

Adapalene API Manufacturer & Supplier in India

Also known as: Differin

CAS: 106685-40-9 Topical Retinoid USP / EP Bulk Supply Available
Adapalene API Manufacturer India | Mediocon Inc
Adapalene — Pharmaceutical Grade API

Product Overview

CAS No: 106685-40-9  |  MF: C₂₈H₂₈O₃  |  MW: 412.52 g/mol

Adapalene is a third-generation topical retinoid used in the treatment of acne vulgaris. It normalizes the differentiation of follicular epithelial cells and has anti-inflammatory properties. Mediocon Inc supplies pharmaceutical-grade Adapalene suitable for gel, cream, and lotion formulations.

Key Features

  • Third-generation topical retinoid
  • USP/EP compliant quality
  • Anti-inflammatory & comedolytic
  • Photostable – suitable for topical use

Applications

  • Acne vulgaris topical gel/cream
  • Combination anti-acne formulations
  • Blackhead and comedone treatment
  • Wrinkle reduction cosmeceuticals

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 NameAdapalene
Also Known AsDifferin
CAS Number106685-40-9
Molecular FormulaC₂₈H₂₈O₃
Molecular Weight412.52 g/mol
CategoryTopical Retinoid / Dermatological Agent
AppearanceWhite to Off-white Powder
GradeUSP / EP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 1.0%
Melting PointN/A
Heavy MetalsNMT 20 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 Adapalene (CAS 106685-40-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Adapalene 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 — Adapalene API

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