Tuesday, 5 January 2016

Zydus Cadila gets USFDA warning

Pharmaceutical company Cadila Healthcare has received a warning letter from the US Food and Drug Administration (USFDA) for two of its manufacturing facilities at Moraiya and Changodar near Ahmedabad for not fully complying with manufacturing standards.

Ahmedabad: Pharmaceutical company Cadila Healthcare has received a warning letter from the US Food and Drug Administration (USFDA) for two of its manufacturing facilities at Moraiya and Changodar near Ahmedabad for not fully complying with manufacturing standards.

Within hours of the company informing the BSE about the warning on Thursday, its share price tumbled nearly 15%to close at Rs 328, eroding Rs 5,871 crore from its market capitalization in a single day.

The company is banking heavily on the US market for its growth. Cadila Healthcare's quarterly sales from the US market crossed Rs 1,000 crore with a growth of 25% in the second quarter of 2015-16.

As a result of the warning over the Current Good Manufacturing Practice regulations of the USFDA, the company will not get any approvals for new drugs in the US market till it complies with the norms. The company, also called Zydus Cadila, has filed more than 235 Abbreviated New Drug Applications (ANDAs) in US and has received approvals for more than 85 as on May 2015.

It is among the top 10 generic companies in US. According to the company, it is working hard to ensure that the commitments made to USFDA are fully fulfilled. However, it said that there were no products in the US market which used API (active pharmaceutical ingredient) of its Changodar facility.

Source : http://health.economictimes.indiatimes.com/news/pharma/zydus-cadila-gets-usfda-warning/50404341

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