Manufacturing License

A Drug Manufacturing License is mandatory for any entity engaged in the manufacture, processing, repacking, re-labelling, or loan manufacturing of pharmaceutical products in India. Manufacturing activities are regulated under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the applicable Good Manufacturing Practices (GMP) requirements prescribed for the respective category of products.

Vivatrix Pharma Consultancy Services provides comprehensive support for obtaining new manufacturing licenses, loan licenses, repacking licenses, product additions, license amendments and statutory approvals for pharmaceutical manufacturing facilities. We assist clients throughout the entire licensing process—from project planning and facility design to regulatory approval—ensuring that the manufacturing premises, plant layout, utilities, equipment, quality control systems, technical personnel, documentation, and GMP requirements comply with applicable regulatory standards.

Our consultants also provide guidance for selecting the appropriate manufacturing license based on the proposed product category, dosage forms, manufacturing activities.