Nothing is going right for Dr. Reddy’s Laboratories, India’s second largest drug maker, since the US FDA issued a warning letter to the company on November 5, 2015.
The US drug regulator has issued a warning letter to Dr. Reddy’s over violation of Good Manufacturing Practice (GMP) at its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology formulation manufacturing facility at Duvvada, Vishkhapatanam, Andhra Pradesh. The action followed the earlier inspection of these sites by the US FDA in November 2014, January 2015 and February 2015 respectively.
The company’s stock has tumbled 33.11% to Rs. 2,885.90 at present, from Rs. 4,314.35 on November 4, 2015. During the same period, Dr. Reddy’s market capitalization as also eroded by Rs. 24,242.24 crore to Rs. 49,305.61 crore.
On receiving the warning letter from the US FDA, G V Prasad, CEO of Dr. Reddy’s had said, “We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities.”
The company, on December 7, 2015, had submitted its response to the US drug regulator.
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