Alkem Labs dips on USFDA observations on Ankleshwar API facility

The stock was down 5% to Rs 1,588 on the BSE.

Alkem Laboratories was down 5% to Rs 1,588 on the BSE after the pharmaceutical company said it has received the inspection report from the US health regulator of the company’s manufacturing facility located at Ankleshwar, which contains three 483 observations.

“The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s API (Active Pharmaceutical Ingredient) manufacturing facility located at Ankleshwar, India from 5th December to 9th December, 2016,” Alkem Laboratories said in a statement.

The company has received the inspection report which contains three 483 observations, it added.

The company said it shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same is proposed to be filed within the timeline stipulated by US FDA.

In September, the USFDA had conducted an inspection at the company’s manufacturing formulations facility located at Daman from September 20 to September 29, 2016, which received 13 observations.

As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

At 12:18 pm; the stock was down 4% at Rs 1,611 as compared to 0.48% decline in the S&P BSE Sensex. A combined 104,542 shares changed hands on the counter on the BSE and NSE.