New Delhi: One of India’s leading vaccine companies, the Panacea Biotec has entered into a joint collaboration for the development, license, manufacturing, supply, and sales of 7 complex generic pharmaceutical products with Biopharma Inc, a generic pharmaceutical company based in the United States. The Panacea Biotec has been so far mainly recognized as a vaccine manufacturer and with this step, it seems to have taken another big leap into biopharmaceutical manufacturing and sales.  

The joint collaboration between two companies has been established for the research, development and manufacturing activities for commercialization of 7 Abbreviated New Drug Applications (ANDAs), which are currently under development at Panacea Biotec, representing a total estimated market potential of more than USD 800 million. 

Under the collaboration, Panacea Biotec will be responsible for development, filing, registration and manufacturing and supply of these ANDAs. Biopharma Inc will be responsible for the importation, warehousing, sales and distribution of these  ANDAs in the United States and its territories.

Both companies intend to expand the scope of their alliance by adding new products to the collaboration from time to time.

Under a previous arrangement, Biopharma Inc is also the exclusive distributor of two of the ANDAs of Panacea Biotec for the US market. These ANDAs have already been commercialized under a separate exclusive license and supply agreement.

The company’s pharmaceutical formulation facility is approved by the international regulatory agencies including USFDA, German Authorities, Brazil (ANVISA), Turkey, Serbia South Africa etc and its product portfolio has expanded internationally with its products reaching out to more than 33 countries.

Panacea Biotec has filed 7 ANDAs out of which 2 have been commercialized with this collaboration.