Laurus Labs has transferred the US Food and Drug Administration (USFDA) approved Abbreviated New Drug Application (ANDA) of Tenofovir Disoproxil Fumarate (TDF) to CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to China and other markets.
The TDF is prescribed for the treatment of Hepatitis B virus (HBV). As part of the transaction, the company, in exchange of the transfer of ANDA, would receive certain upfront and milestone payments in different phases. Both parties are in discussions to allow Laurus to continue to manufacture and market TDF for the US market and to potentially supply API for the China market.
Laurus Labs is a leading research and development driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of APIs for anti-retroviral (ARV) and Hepatitis C. It also manufactures APIs in oncology and other therapeutic areas.