Cadila Healthcare receives EIR from USFDA

Leading pharma company announced that its manufacturing plant located at SEZ, Ahmedabad has received an EIR from the US drug regulator.

The US Food and Drug Administration (USFDA) had conducted an inspection at the facilities from March 25 to April 3, 2019.The Establishment Inspection Report (EIR) report stated that the classification of the facility is under the category, Voluntary Action Indicated (VAI). The status means objectionable conditions were found and documented, but the agency is not prepared to take or recommend regulatory action.

Also on Monday, Zydus Cadila announced the completion of enrolment for EVIDENCES IV, Phase 2 Clinical Trial of Saroglitazar Magnesium for patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including Non-Alcoholic SteatoHepatitis (NASH) in the US. Saroglitazar Magnesium is an investigational new drug molecule undergoing clinical evaluation for the treatment of liver diseases like NASH in the US.

Meanwhile, on Monday, the stock of Cadila Healthcare closed at Rs. 242.50 per share, down by 1.14 per cent on BSE. The stock opened at Rs. 247.50 and touched a high of Rs. 248.80 in the morning session.