Cipla falls 5% on fears of action against Goa unit

The share price of drug marker Cipla dived 5 per cent in Friday's session after Equirius said its Goa unit will require extensive changes to meet the USFDA guidelines.

According to Equirius, the unit received Form 483 with 12 observation that runs through 38 pages. Observations are largely related to procedure and SOP lapses, it said.

The unit caters to about one-third of the US businesses. The facility will require very extensive changes in SOPs procedures and processes.

As per Equirius, it could take a bit longer to the company to resolve issues. It also sees a strong likelihood of OAI (official action indicated) classification and thus a warning letter.

United States Food and Drug Administration (USFDA) conducted a cGMP inspection at the Goa manufacturing facility from September 16-27, 2019.

“The inspection ended with 12 observations, none of which are related to data integrity. The Company will respond to the agency within the stipulated timeline,” Cipla had said on September 28.

The stock was trading down 5 per cent at Rs 405 level on BSE at 10.05 am.