Cadila Healthcare Limited announced today that the USFDA inspected its Moraiya facility from 5th February to 9th February, 2018. At the end of the inspection, no observation (483) is issued.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 21000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.
For the third quarter ended December 31, 2017, Zydus Cadila received approval for 24 new products for the US market and filed 10 additional ANDAs with the USFDA. The Company launched 2 new products in the US during the quarter.
In India, the company launched 12 new products including line extensions during the quarter with 4 first in India launches. During the quarter, the company received the marketing approval from the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) to commercialize Lipaglyn™ (Saroglitazar Magnesium) in Mexico for the treatment of Dyslipidemia in patients with diabetes mellitus type 2 and Hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins.
Taking its efforts in public health and care a step further, the company entered into a public private partnership with the Indian Council of Medical Research (ICMR) during the quarter, to launch new diagnostic kits, developed by ICMR’s National Institute of Virology (NIV), Pune to detect neglected infectious diseases in livestock.