Shamkris Global Group

FDA License for Manufacturing Products

What is FDA License for Manufacturing Products?

The company/distributor/independent agent to be an authorized Indian Agent for dealing with local/foreign drugs and cosmetics must have a manufacturing license from the Central Drugs Standard Control Organisations (CDSCO).

The application for the manufacturing drug License of medical devices in India is made according to Rule 27 to the State Drug Licensing Authority, CDSCO Zonal/Sub-zonal Office, and Drugs Controller General in India CDSCO (HQ).

Manufacturing of notified medical devices under the Central License Approving Authority (CLAA) for sale in India, a manufacturing drug license in form- 28 is required under Drugs and Cosmetics Rules. Rule 76 of Drugs and Cosmetics describes the information/data required for a grant of a manufacturing drug license.

Manufacture for sale of Disposable Hypodermic Syringes, Needles, and Disposable Perfusion sets and in-virto Diagnostic Devices are regulated by the concerned State Drug Licensing Authority.

Why this License is Required?

In order to make sure that food from the local market is hygienic, the Food and Drug Administration (FDAMaharashtra will soon be issuing a notice to vendors in local markets to obtain a food safety license from the authority.  Everybody who is dealing with food needs to have registration or license with us.

Who can get FDA Manufacturing License?

Drug Products

Medical Devices


Color Additives



Dietary Supplements

Labeling Products

Document Required for FDA Manufacturing License

Documents Checklist for FDA Manufacturing License (Maharashtra) for Drugs & Cosmetics

Checklist of Documents for Grant of License

Role of Shamkris and Process of FDA Manufacturing License

Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.

The License process described below:

Advisory for the document required

Preparation of documents as per application & list of documents.

Application File

Inspection by the department if required

Liason department

License issued

Applicable for 3 Years

Renewal when due

Who can issue the FDA Manufacturing License?


FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured

Form-29 is a license to manufacture drugs for the purpose of Examination Testing and Analysis. The application made in Form-30, and the certificate is valid for one year.
Manufacturing license is a legal premise for a company to conduct manufacturing activities in Malaysia under the provision of the Industrial Coordination Act (ICA) 1975.