Active Pharmaceutical Ingredient

Apremilast (CAS 608141-41-9) API Manufacturer & Supplier in India

Also known as: Otezla (brand)

CAS: 608141-41-9 PDE4 Inhibitor USP / BP / IP Bulk Supply Available
Apremilast API Manufacturer India | Mediocon Inc
Apremilast — Pharmaceutical Grade API

Product Overview

CAS No: 608141-41-9  |  MF: C₂₂H₂₄N₂O₇S  |  MW: 460.50 g/mol

Apremilast is an oral PDE4 inhibitor used in the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis. It modulates inflammatory mediators to reduce symptoms. Mediocon Inc supplies pharmaceutical-grade Apremilast meeting IP/BP/EP/USP standards for pharma manufacturers.

Key Features

  • Oral PDE4 inhibitor
  • IP/BP/EP/USP compliant quality
  • Psoriasis and psoriatic arthritis treatment
  • Suitable for oral tablet formulations

Applications

  • Oral tablets for plaque psoriasis
  • Psoriatic arthritis therapy
  • Immunomodulatory drug manufacturing
  • Pharmaceutical research

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 NameApremilast
Also Known AsOtezla (brand)
CAS Number608141-41-9
Molecular FormulaC₂₂H₂₄N₂O₇S
Molecular Weight460.50 g/mol
CategoryImmunology / PDE4 Inhibitor
AppearanceWhite to Off-White Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
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 Apremilast (CAS 608141-41-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Apremilast 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 — Apremilast API

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