Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin Limited having planned to enter into a Business Transfer Agreement (BTA) with Lupin Manufacturing Solutions Limited (LMSL), wholly owned subsidiary of the company, to carve out two Active Pharmaceutical Ingredients manufacturing sites situate at Dabhasa and Visakhapatnam and select R&D operations, including fermentation, at Lupin Research Park, Pune. Today i.e. October 16, 2023, the company has entered into a BTA with LMSL in connection with the carve out.

Lupin receives tentative approval from U.S. FDA for Apalutamide Tablets

Global pharma major Lupin Limited (Lupin) has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech, Inc. This product will be manufactured at Lupin's Pithampur facility in India.

Apalutamide Tablets, 60 mg, (RLD Erleada) had estimated annual sales of USD 1,185.5 million in the U.S. (IQVIA MAT July 2023).