Active Pharmaceutical Ingredient

Calcipotriene API Manufacturer & Supplier in India

Also known as: Calcipotriol

CAS: 112965-21-6 Dermatological USP / BP / IP Bulk Supply Available
Calcipotriene API Manufacturer India | Mediocon Inc
Calcipotriene — Pharmaceutical Grade API

Product Overview

CAS No: 112965-21-6  |  MF: C₂₇H₄₀O₃  |  MW: 412.60 g/mol

Calcipotriene (Calcipotriol) is a synthetic vitamin D3 analogue used primarily in the treatment of plaque psoriasis. It works by slowing abnormal skin cell growth and promoting normal cell development. Mediocon Inc supplies pharmaceutical-grade Calcipotriene meeting IP/BP/EP/USP standards for topical formulation manufacturers.

Key Features

  • Synthetic Vitamin D3 analogue
  • IP/BP/EP/USP compliant quality
  • Used in psoriasis treatment
  • Suitable for topical cream and ointment formulations

Applications

  • Topical creams for psoriasis
  • Ointment formulations
  • Combination dermatological products
  • R&D 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 NameCalcipotriene
Also Known AsCalcipotriol
CAS Number112965-21-6
Molecular FormulaC₂₇H₄₀O₃
Molecular Weight412.60 g/mol
CategoryDermatological / Vitamin D Analogue
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay97.0% – 103.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 10 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 Calcipotriene (CAS 112965-21-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Calcipotriene 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 — Calcipotriene API

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