Share price of Suven Pharmaceuticals hit a record high of 3.67 percent on Monday after the company announced that the United States Food & Drug Administration (US FDA) has categorized the surveillance inspection conducted in its Subsidiary Casper Pharma Ltd in Hyderabadas"Voluntary Action Indicated (VAI)"and estimated it as being "closed," reports said.
The VAI label from the US FDA indicates that "objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action."
The Establishment Inspection Report (EIR) cited that the company has already initiated remedial actions recommended by US FDA, thus helping to improve the confidence of investors and thus fetching its shares an all-time high of RS 1,255on 9 Sep., according to Equitypandit.
During the inspection conducted by the US FDA between July eight and July 12, the agency observed two procedural issues.
The pharmaceutical company stated at that time that the issues would be solved on time: "Following the inspection, we have been issued a Form 483 with two observations, which are procedural in nature. We are committed to addressing these observations within the stipulated timeline," a report from Indian Pharma Post, read.
It was in March this year Suven Pharmaceuticals, a leading bio- pharmaceutical company developing and manufacturing drug intermediates, announced its merger with Cohance Life Sciences. The company founded in 1989 is estimated to have a total market capitalization of Rs 30,671.26 crore, according to Business Standard.
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