Cipla stocks gained by 5% after FDA inspection with no data integrity and repeat observations at its indore facilitated formulation unit.
US FDA conducted a routine current Good Manufacturing Practices (cGMP) audit at Cipla's Indore formulations facility from 2nd April 2018 till 13th April 2018.
"This was in the normal course of business. There were no data integrity and/or repeat observations. At this stage, the Company believes the observations are unlikely to have any material adverse impact", said Kedar Upadhye, Global Chief Financial Officer, Cipla.
In 2015, Indore based manufacturing plany of Cipla had received nine observations from the USFDA which were cleared in 2016. In January 2018, the US FDA had conducted a product specific pre-approval inspection at Goa plant and issued certain observations which were procedural in nature. After that inspection, it had received two product approvals from the plant.
