Enfuvirtide Acetate API Manufacturer & Supplier in India

Enfuvirtide Acetate (T-20 Acetate) is the acetate salt of Enfuvirtide, a synthetic 36-amino acid peptide HIV fusion inhibitor used in the treatment of HIV-1 infection in treatment-experienced patients. Mediocon Inc manufactures Enfuvirtide Acetate API to IP/BP/EP/USP standards in its GMP-certified facility in Aurangabad, Maharashtra, India.

Our Enfuvirtide Acetate API is supplied to antiretroviral injectable pharmaceutical manufacturers globally. Full quality documentation including CoA, MSDS, COO, and DMF support is provided.

Key Features

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

Applications

• HIV-1 infection treatment in treatment-experienced patients
• Antiretroviral injectable formulations
• HIV fusion inhibitor drug manufacturing
• Antiretroviral therapy (ART) pharmaceutical research

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 Enfuvirtide Acetate (CAS 159519-65-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Enfuvirtide Acetate 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