Share price of Strides Arcolab tumbled sharply in early trade to Rs 839 on Monday after the company informed the BSE that the sterile manufacturing facility 2 (SFF) at Bangalore of Agila Specialties Private Ltd has received a warning letter from the United States Food and Drug Administration.
Agila Specialties Private Ltd is a whollly owned subsidiary of the company.
The stock, however, recovered a part to rule at Rs 866.85, still down 3.7 per cent down over the previous day's close of Rs 900.20.
The stock's 52-week high and low are Rs 1,224.9 and Rs 552.65.
The US FDA inspected SFF in the month of June 2013 and the inspection resulted in issuance of Form FDA 483 with observations. The company responded to the 483 observations by implementing corrective actions, a statement from the company said.
The company is committed to working collaboratively and expeditiously with the US FDA to resolve concerns cited in the warning letter in the shortest possible time, it further added.
Further, the Oncology facility at Bangalore of Agila Specialties was also inspected recently by the US FDA and this facility has cleared the inspection with Zero 483 status, said the company.
The company has eight US FDA approved sterile manufacturing facilities.