Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Lansoprazole delayed release orally disintegrating tablets (US RLD- Prevacid), 15 mg and 30 mg and tentative approval for Linagliptin tablets (US RLD- Tradjenta), 5 mg.
Lansoprazole is in a class of drugs called proton pump inhibitors (PPI) which blocks the production of acid by the stomach. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Linagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
The group now has 236 approvals and has so far filed over 340 ANDAs since the commencement ofthe filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.