Cipla Gets Eight Observations After FDA Inspection
Cipla says it will work closely with the FDA and remains committed to address these observations comprehensively within the stipulated time.
Cipla Ltd. announced on Wednesday that the company received eight observations from the US Food and Drug Administration for its manufacturing facility in Bengaluru.
The FDA conducted an inspection at the manufacturing facility in Virgonagar from Nov. 7 to Nov. 13, according to an exchange filing.
At the conclusion of the inspection, the company received eight observations in Form 483. The company will work closely with the FDA and remains committed to address these observations comprehensively within stipulated time, it said.
Cipla's consolidated net profit rose 13% in the second quarter of the current financial year, meeting analysts' estimates. The drugmaker posted a profit of Rs 1,305 crore in the quarter ended September, according to an exchange filing.
Earlier on Oct. 31, the FDA tagged the company's Goa facility as 'voluntary action indicated'. With the successful completion of the inspection, Cipla can now launch large products from the facility in the US. Among the anticipated large product launches from the Goa facility is the generic version of the oncology drug ambraxane, which is used in chemotherapy treatments.
This is an important development for the company as Citi Research's post-earnings report had said in a report that pancreatic cancer treatment drug abraxane's approval was contingent upon the Goa unit clearance.
Shares of Cipla closed 1.28% lower to Rs 1,505.60 apiece on the NSE, compared to a 1.36% decline in the benchmark Nifty 50. The stock has risen 21.37% in the last 12 months and 20.81% on a year-to-date basis.
Twenty-three out of the 38 analysts tracking the company have a 'buy' rating on the stock, eight suggest 'hold' and seven recommend 'sell', according to Bloomberg data. The average of 12-month analyst price targets implies a potential upside of 7.4%.
