Drug company Strides Arcolab on Monday said that a sterile manufacturing facility (SFF) of its subsidiary Agila Specialties in Bangalore has received a warning letter from the United States Food and Drug Administration (US FDA) following an inspection earlier this year. The company reported the receipt of the warning letter in a filing to the stock exchanges.
?The USFDA inspected SFF in June and the inspection resulted in issuance of Form FDA 483 with observations. The company responded to the 483 observations by implementing corrective actions,? it said. ?The company is committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time.? The Form FDA 483 is a form used by the USFDA to document concerns observed during inspections.
Strides, which has 8 US FDA approved sterile manufacturing facilities, said that the US regulator had cleared a different facility of Agila in a recent inspection. ?The oncology facility at Bangalore of Agila Specialties Private Limited was also inspected recently by the US FDA and this facility has cleared the inspection with ?Zero 483 status?.
Shares of Strides Arcolab fell to R839 from R901 in early morning trade soon after the announcement. The stock closed at R869.10, down 3.45% at the end of Monday?s trading on the Bombay Stock Exchange.
Earlier this month, US drug company Mylan Inc received approval from the Cabinet Committee on Economic Affairs for its proposal to acquire Agila Specialties, which is an injectibles business.
The $1.8-billion deal is the third-largest in the Indian pharma space after Daiichi Sankyo?s $4.6-billion acquisition of Ranbaxy Labs in 2008 and Abbott?s $3.7-billion takeover of Piramal Healthcare in 2010.
