Alembic Pharma says plants successfully inspected by USFDA

Drug firm Alembic Pharmaceuticals' two API facilities at Panelav have been successfully inspected by the United States Food and Drug Administration (USFDA), the company today said.

"The company's API facilities, API-I and API-II, both located at Panelav, have been successfully inspected by the USFDA between June 20, 2016, and June 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 Panelav facility.

"The formulations facility of the company 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 USFDA.

According to the company's website, formulations account for around 65% of the total business for Alembic Pharmaceuticals. It has three manufacturing facility 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%, from its previous close.