Active Pharmaceutical Ingredient

Canagliflozin API Manufacturer & Supplier in India

Also known as: Invokana API; JNJ-28431754

CAS: 842133-18-0 Metabolic / SGLT2 Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Canagliflozin API — Mediocon Inc
Canagliflozin — Pharmaceutical Grade API

Product Overview

CAS No: 842133-18-0  |  MF: C₂₄H₂₅FO₅S  |  MW: 444.52 g/mol

Canagliflozin is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Metabolic / SGLT2 Inhibitor category. Mediocon Inc supplies high-purity Canagliflozin API (CAS 842133-18-0) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Canagliflozin is used in: Type 2 diabetes; heart failure; CKD; SGLT2 inhibitor. Mediocon's Canagliflozin meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

  • High-purity pharmaceutical grade API (NLT 98.0% assay)
  • IP / BP / EP / USP compliant with full analytical verification
  • Full CoA, MSDS/SDS, and COO documentation with every batch
  • GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

  • Type 2 diabetes; heart failure; CKD; SGLT2 inhibitor
  • Pharmaceutical formulation and drug product manufacturing
  • Bioequivalence and clinical research studies
  • Generic drug development (ANDA/NDA)

Why Choose Mediocon

  • ISO 9001:2015 & WHO-GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF support
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings (FDA, EMA, WHO)

Product Specifications

Product NameCanagliflozin
Also Known AsInvokana API; JNJ-28431754
CAS Number842133-18-0
Molecular FormulaC₂₄H₂₅FO₅S
Molecular Weight444.52 g/mol
CategoryMetabolic / SGLT2 Inhibitor
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
StorageStore in a cool, dry place; protected from light and moisture

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
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 Canagliflozin (CAS 842133-18-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Canagliflozin 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 — Canagliflozin API

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