Active Pharmaceutical Ingredient

Valrubicin API Manufacturer & Supplier in India

Also known as: N-trifluoroacetyladriamycin-14-valerate; Valstar; AD 32

CAS: 56124-62-0Anticancer APIAnthracycline AntibioticIP / BP / EP / USPGMP CertifiedAurangabad, India
Valrubicin API — Mediocon Inc
Valrubicin — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 56124-62-0  |  MF: C₃₄H₃₆F₃NO₁₃  |  MW: 723.64 g/mol

Valrubicin is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Valrubicin is a semi-synthetic analogue of doxorubicin used as intravesical therapy for BCG-refractory bladder carcinoma in situ (CIS). It penetrates bladder cells and inhibits topoisomerase II, disrupting nucleoside incorporation into DNA and RNA.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Bladder carcinoma in situ (CIS) intravesical therapy
  • BCG-refractory bladder cancer
  • Topoisomerase II inhibition research
  • Oncology pharmaceutical development

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 NameValrubicin
Also Known AsN-trifluoroacetyladriamycin-14-valerate; Valstar; AD 32
CAS Number56124-62-0
Molecular FormulaC₃₄H₃₆F₃NO₁₃
Molecular Weight723.64 g/mol
CategoryAnthracycline Antibiotic / Intravesical Anticancer API
AppearanceDark red to reddish-orange crystalline powder
SolubilityPractically insoluble in water; soluble in DMSO and polyoxyl castor oil formulations
GradeIP / BP / EP / USP

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
Batch No.VRB/24033049
Mfg DateMAR 2026
Exp DateFEB 2031
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 Valrubicin (CAS 56124-62-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Valrubicin 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 — Valrubicin API

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