Drug Manufacturing Licenses in India – Process, Documents & Regulatory Requirements

Drug Manufacturing Licenses are mandatory for companies involved in producing medicines, cosmetics, or pharmaceutical products in India. These licenses ensure that the manufacturer follows quality standards, safety protocols, and GMP (Good Manufacturing Practices) as per the Drugs and Cosmetics Act, 1940. To obtain a Drug Manufacturing License, applicants must meet facility standards, submit required documents, undergo inspections, and comply with state FDA norms. Different categories such as Allopathic, Ayurvedic, Homeopathic, and Cosmetics require separate approvals. Agile Regulatory offers complete assistance for documentation, application filing, plant setup compliance, and end-to-end support for obtaining Drug Manufacturing Licenses smoothly.