Regulatory Affairs

Parabolic Drugs Limited aims to increase its presence in the regulated markets. The Company is striving to get quality accreditations for its products, systems, procedures and safe environment, prerequisites for the regulated markets.

Apart from this, the Company has an ambitious plan for filing of Drug Master Files (DMF) for its API being manufactured by a noninfringing process. Both the Panchkula facility and the Derabassi site are registered in the USA with US FDA, as manufacturers and suppliers of quality API and intermediates.

There are currently 38 DMFs filed in Europe, the USA Japan and Canada, for registration of the Company’s API. It has also received for certificates of Suitability (COS) for its key molecules.

For details on the DMF filing and our regulatory strength , please feel free to contact us.