Active Pharmaceutical Ingredient

Photofrin API Manufacturer & Supplier in India

Also known as: Porfimer Sodium; Photofrin II; CL-184116

GMP Certified IP / BP / USP Photosensitizer / Antineoplastic Agent Aurangabad, India
Photofrin API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Photofrin IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 65348-80-9

Product Overview

Photofrin (Porfimer Sodium) is a photosensitizing agent used in photodynamic therapy (PDT) for the treatment of various cancers. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India under GMP conditions, it is supplied to oncology and research institutions globally. CAS No: 65348-80-9.

Therapeutic Applications
  • Photodynamic therapy (PDT) of esophageal cancer
  • Treatment of obstructive endobronchial non-small cell lung cancer
  • PDT for superficial gastric cancer
  • High-grade dysplasia in Barrett's esophagus treatment

Technical Specifications

ParameterSpecification
CAS Number65348-80-9
Molecular FormulaC34H36N4Na2O8
Molecular Weight652.66 g/mol
GradeIP / BP / USP
CategoryPhotosensitizer / Antineoplastic Agent
AppearanceDark red to maroon crystalline powder
SolubilityFreely soluble in water, slightly soluble in ethanol, practically insoluble in other organic solvents.
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support

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 Photofrin — CAS 65348-80-9 (CAS 65348-80-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Photofrin — CAS 65348-80-9 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 — Photofrin — CAS 65348-80-9 API

What is the minimum order quantity for Photofrin — CAS 65348-80-9 API?
Mediocon Inc supplies Photofrin — CAS 65348-80-9 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 Photofrin — CAS 65348-80-9 does Mediocon supply?
We supply Photofrin — CAS 65348-80-9 conforming to IP / BP / 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 Photofrin — CAS 65348-80-9 API?
Every shipment of Photofrin — CAS 65348-80-9 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 Photofrin — CAS 65348-80-9 bulk orders?
Standard lead time for Photofrin — CAS 65348-80-9 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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