Drug firm Dishman Pharmaceuticals and Chemicals Ltd has received an Establishment Inspection Report (EIR) from the US health regulator on closure of inspection of its Bavla facility in Gujarat.
“The company’s Bavla facility was successfully inspected by the USFDA in July 2016, which was intimated to the stock exchanges on July 9, 2016. In this regard, the company received the Establishment Inspection Report (EIR) from the USFDA for the facility on February 1, 2017,” Dishman Pharma said in a regulatory filing.
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
“Thus, the company’s facilities in Bavla, Naroda and Switzerland continue to be approved by the USFDA,” Dishman Pharma said.
The Bavla plant is mainly used for making pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
Shares of Dishman Pharmaceuticals were trading 3.05 per cent up at Rs. 234.90 apiece on BSE.