Shares of Lupin and Aurobindo Pharma hit their respective fresh 52-week lows, extending their losses on BSE, after US drug regulator issued Form 483 with observations.
Lupin, the largest loser among Sensex pack, was down 2.5% at Rs 1,305, after the company on Friday said that the US Food and Drug Administration (USFDA) issued Form 483 with three observations for its Goa facility.
“Recently, the company’s Goa manufacturing facility underwent an inspection by the USFDA. The said inspection was completed on April 7, 2017, subsequently to which, the USFDA issued Form 483 citing three observations,” Lupin said in a BSE filing.
The company is in the midst of putting together a response to address the said observations, it added.
The company has multiple facilities which cater to the US and other advanced markets and undergo periodic routine inspection by the USFDA or other regulators from different countries, in the normal course of business, Lupin said.
In past seven trading sessions, the stock of Lupin dipped 9% against 1.6% rise in the S&P BSE Sensex.
Aurobindo Pharma hit 52-week low of Rs 592 in intra-day trade, was down 11% in past nine trading sessions. The company on April 19 informed the stock exchanges that its formulations manufacturing facility at Bachupally in Hyderabad had received Form 483 with six observations.
The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017.
“At the end of the inspection, we have been issued a Form 483 with 6 observations. The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines,” Aurobindo Pharma said in BSE filing.
Meanwhile, GlaxoSmithKline Pharmaceuticals, the other pharmaceutical stocks too trading at its fresh 52-week low of Rs 2,450 on BSE against unchanged in the benchmark index at 12:52 pm.