Active Pharmaceutical Ingredient

Baricitinib API Manufacturer & Supplier in India

Also known as: Olumiant (brand)

CAS: 1187594-09-7 JAK Inhibitor USP / BP / IP Bulk Supply Available
Baricitinib API Manufacturer India | Mediocon Inc
Baricitinib — Pharmaceutical Grade API

Product Overview

CAS No: 1187594-09-7  |  MF: C₁₆H₁₇N₇O₂S  |  MW: 371.42 g/mol

Baricitinib is a selective Janus kinase (JAK1 and JAK2) inhibitor used in the treatment of moderate-to-severe rheumatoid arthritis, alopecia areata, and COVID-19 in hospitalized adults. It reduces inflammation by blocking cytokine signaling pathways. Mediocon Inc supplies pharmaceutical-grade Baricitinib meeting IP/BP/EP/USP standards.

Key Features

  • Selective JAK1/JAK2 inhibitor
  • IP/BP/EP/USP compliant quality
  • Rheumatoid arthritis and alopecia areata treatment
  • Oral once-daily tablet formulation

Applications

  • Oral tablets for rheumatoid arthritis
  • Alopecia areata treatment
  • COVID-19 hospitalized patient therapy
  • Immunology 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 NameBaricitinib
Also Known AsOlumiant (brand)
CAS Number1187594-09-7
Molecular FormulaC₁₆H₁₇N₇O₂S
Molecular Weight371.42 g/mol
CategoryImmunology / JAK 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 Baricitinib (CAS 1187594-09-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Baricitinib 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 — Baricitinib API

What is the minimum order quantity for Baricitinib API?
Mediocon Inc supplies Baricitinib 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 Baricitinib does Mediocon supply?
We supply Baricitinib 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 Baricitinib API?
Every shipment of Baricitinib 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 Baricitinib bulk orders?
Standard lead time for Baricitinib 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.
💬
Mediocon AI
Hello 👋 How can I help you today?