Cipla shares go down by 7% after Pithampur unit gets 8 observations from USFDA

Shares of Cipla fell nearly 7 per cent in morning trade on Monday after the company said the US health regulator has issued 'Form 483' with eight observations after inspecting its Pithampur-based manufacturing facility in Madhya Pradesh.

The stock went down by 6.78 per cent to Rs 956.20 on the BSE, while it tanked 6.87 per cent to Rs 955.25 on the NSE.

On Monday, at 10:47 am IST, Cipla saw a volume of 1.4 lakh shares on the BSE, which is a 6.63-fold increase in comparison to the last two weeks average daily volume.

The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6–17, the Mumbai-based drug firm said in a regulatory filing on Saturday.

On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added.

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said.

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that, in its judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

With inputs from PTI