Topotecan API Manufacturer & Supplier in India

Topotecan is a high-purity Antineoplastic Agent supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Topotecan is a semisynthetic derivative of camptothecin and a topoisomerase I inhibitor used in oncology for the treatment of ovarian cancer, small cell lung cancer, and cervical cancer.

Key Features

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

Applications

• Ovarian cancer (second-line treatment)
• Small cell lung cancer
• Cervical cancer
• Antineoplastic formulation 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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Topotecan (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Topotecan 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