Alembic Pharma gets USFDA observations for Panelav plant

Drug firm Alembic Pharmaceuticals today said it has received four observations from the US health regulator after the inspection of Panelav facility.

“The formulations facility of the company at Panelav, Halol was inspected by the USFDA from March 21 to 25. The company had received four observations which are being addressed by our regulator and quality team,” Alembic Pharmaceuticals said in a filing to BSE.

The company, however, did not provide any details about the observations it has received from the United States Food and Drug Administration (USFDA).

According to the company’s website, formulations accounts for around 65 per cent of the total business for Alembic Pharmaceuticals. It has three manufacturing facility for formulations —— Vadodara and Panelav at Gujarat and Baddi in Himachal Pradesh.