Fulvestrant API Manufacturer & Supplier in India

Fulvestrant is a selective estrogen receptor degrader (SERD) used in the treatment of hormone receptor-positive (HR+) metastatic breast cancer in postmenopausal women. It binds to and degrades the estrogen receptor, blocking estrogen-driven tumor growth.

Mediocon Inc supplies Fulvestrant IP/BP/EP/USP as a high-purity oncology active pharmaceutical ingredient for licensed parenteral formulation manufacturers. With extensive GMP quality controls and multi-pharmacopoeial compliance, our Fulvestrant supports global regulatory submissions.

Key Features

• Selective estrogen receptor degrader (SERD)
• No partial agonist activity
• Multi-pharmacopoeial compliance (IP/BP/EP/USP)
• Compatible with injectable formulations

Applications

• HR+ metastatic breast cancer formulations
• Parenteral oncology injectables
• Endocrine therapy pharmaceutical manufacturing
• Oncology clinical research supply

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 Fulvestrant (CAS 129453-61-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Fulvestrant 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