A drug license ensures that drugs are manufactured, distributed, and sold in compliance with regulatory standards. It guarantees that drugs are safe, effective, and of high quality, minimizing health risks to the public.
Issued to a person or company for manufacturing drugs for sale or distribution.
Issued for wholesale activities including purchase, sale, distribution, and storage of drugs.
Issued for retail sale of drugs directly to consumers.
Allows manufacturing of drugs on behalf of another license holder.
Issued with specific restrictions on manufacturing or sale quantity.
Required for manufacturing, selling, or distributing narcotic drugs.
Issued for establishing and operating a blood bank.
Required for manufacturing cosmetics containing drugs, such as creams and ointments.
Issued for importing drugs into India.
Documents needed for company registration
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The applicant must submit an application to the Delhi Drugs Control Department along with required documents. Inspection will be conducted before approval.
Applicants must apply to the Maharashtra FDA, ensuring compliance with GMP and providing all necessary documentation.
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Manufacturers must follow GMP to ensure product safety and efficacy.
Proper records of raw materials, batch production, and testing must be maintained.
Implementation of quality control measures to ensure drug safety.
Manufacturers must report any adverse reactions associated with their drugs.
Periodic renewal of the drug license is mandatory to continue operations legally.