The US-FDA had issued an import alert under clauses 99-32 and 66-40 in March of 2017 and a warning letter in May of 2017 for the company’s Vishakhapatnam facility.
“Divi's Laboratories has filed detailed responses and given updates to the Form-483 and the warning letter within the stipulated time. Divi's Laboratories, along with its external consultants, specialists and subject matter experts, has taken up appropriate remediation measures to address the concerns raised by US-FDA,” the company said in a BSE filing.
The company awaits further action from US-FDA in this regard, it added.
At 11:59 am; the stock was up 15% at Rs 783 on BSE, as compared to 0.62% rise in the S&P BSE Sensex. Around 1.42 million shares changed hands on the counter on BSE so far.
The stock had hit a 52-week low of Rs 533 on May 29, 2017 in intra-day trade after the US drug regulator had issued a warning letter for its unit-II at Visakhapatnam.