The US Food and Drug Administrator (FDA) has listed eight observations in the Form 483 it has issued to Cipla following recent inspection at the Pithampur facility. CNBC TV-18 has gained access to the observations.
Cipla has failed to establish, write, and follow any preventive measures for microbiological contamination, appropriate controls over computers and related systems have not been taken, and procedures for handling written or oral complaints have been compromised, it said.
At 10am, the stock traded at Rs 933.25 on the NSE, lower by 1.8 percent from its previous close. It has tumbled over 8 percent since February 20 when the company informed exchanges about the Form 483.
Also Read: Cipla sheds 6% after USFDA issues Form 483 to Pithampur plant
The US FDA’s Good Manufacturing Practices (cGMP) inspection at the drug manufacturing unit was carried out between February 6 and 17.
Field reports are not being submitted as required under SOP (standard operating procedure), procedures applicable to quality unit are not fully followed and lab records do not include complete data, were some of the other observations made by the US FDA.
The Pithampur plant manufactures respiratory products such as Proventil, Brovana, and Pulmicort, as well as pipeline products such as Advair. According to analyst estimates, the plant's contribution to company's FY23 consolidated EBITDA will be more than 15 percent and around 5 percent of the consolidated revenue.
Brokerages remain 'overweight' on the stock and are monitoring any potential impact on timeline of launches. JPMorgan has a target price of Rs 1,210 on the stock, while Macquarie has a target of Rs 1,235.