Alkem Laboratories receives 4 observations post USFDA inspection

The USFDA has conducted an inspection at Alkem Laboratories’ manufacturing facility situated at Baddi, Himachal Pradesh from May 13 to 17, 2019.

The United States Food and Drug Administration (USFDA) post the inspection stated that the company has received a Form 483 with four observations. The company is now expected to put a detailed response with acceptable corrective and preventive measures to address the USFDA observations. The company has to respond to the USFDA observation timely with the USFDA instructions.

Alkem Laboratories is engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.

On Friday, the shares of Alkem Laboratories opened at Rs. 1,674 against Thursday’s close of Rs 1,682. At closing hours, the stock was trading at Rs 1,687.55, 0.28 per cent higher than the previous close. It reached an intraday high of Rs. 1,696 and an intraday low of Rs. 1,674 per share on the BSE. The 52-week high stood at Rs. 2,265 and 52-week low was at Rs. 1,674 per share on the BSE.