Cadila hits 52-week low, down 15% on USFDA warning for 2 units
"Company has received a warning letter issued by the US Food and Drug Administration relating to its Moraiya formulation facility and Ahmedabad oncology API facility (Zyfine),"
says the Gujarat-based pharma company in its filing to exchanges.
The company further says it is working hard to ensure that commitments made to USFDA are fully completed, adding it will continue to take all necessary steps to ensure that US FDA is fully satisfied with remediation of these two facilities. Cadila had received Form 483 observations for Moraiya facility in August 2014 and for Zyfine facility in December 2014. Lack of standard operating procedures, quality controls etc were some of observations highlighted in Moraiya facility. Moraiya facility contributes around 25 percent to its US sales that increased 16 percent year-on-year in September quarter. Analysts see possible delays in USFDA approvals expected in October-March FY16. They say the company has initiated site transfer for critical products such as Nexium, Toprol generic from Moraiya facility.
According to them, new formulations facility in SEZ received establishment inspection report from the USFDA may provide visibility for US sales. They say content of warning letter will be key, adding there will be no financial impact from warning letter for Ahemdabad API facility. Zydus Cadila group has eight manufacturing facilities, which spread over five states of India. It has formulations manufacturing plants at Moraiya (Ahmedabad), Baddi, Sikkim and Goa in India while finished dosage plant in Brazil. Its API manufacturing facilities are at Dabhasa, Ankleshwar and Navi Mumbai (Zydus Takeda). The group aims to record revenue of Rs 10,000 crore by 2015-16 (against Rs 8,600 crore in FY15). At 11:39 hours IST, the scrip of Cadila Healthcare was quoting at Rs 326.55, down Rs 58.60, or 15.21 percent amid high volumes on the BSE.
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