Drug firm Alembic Pharmaceuticals’ two API facilities at Panelav have been successfully inspected by the USFDA, the company today said.
“The company’s API facilities i.e. API I and API II, both located at Panelav, have been successfully inspected by the USFDA between June 20-29, 2016. The company did not receive any Form 483 observations,” Alembic Pharmaceuticals said in a BSE filing.
In April this year, the company had received four observations from the US health regulator after the inspection of the Panelav facility.
“The formulations facility at Panelav, Halol, was inspected by the USFDA from March 21 to March 25.
The company had received four observations, which are being addressed by our regulator and quality team,” Alembic Pharmaceuticals had said.
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 account for around 65 per cent of the total business for Alembic Pharmaceuticals. It has three manufacturing facilities for formulations — Vadodara and Panelav in Gujarat and Baddi in Himachal Pradesh.
The stock was trading at Rs 583.66 on BSE, up 6.66 per cent, from its previous close.