Ahmedabad based drug major Cadila Healthcare (Zydus) has informed the Bombay Stock Exchange (BSE) on Tuesday that the company has received a letter from the US Food and Drugs Administration (USFDA) conveying that the 'facilities at Moraiya are acceptable'.
Cadila said in the statement that, "wtith this the warning letter issued by them earlier is resolved". The company's stocks soared 4.74 per cent at BSE after the announcement of USFDA revoking the warning letter came in and ended the day's trade at Rs 836.65.
Sources in Zydus informed that global business accounts for nearly 50 per cent of its revenues, and US contributes a substantial portion. It is estimated that US operations contribute to over 25 per cent of the company's net sales. Zydus operates in US through its wholly-owned subsidiary Zydus Pharmaceuticals (USA) Inc.
The company's Moraiya facility at the outskirts of Ahmedabad had received a warning letter from the USFDA in June 2011 citing non-conformity of the facility with USFDA norms. Post this, the facility was again inspected in February this year and an approval was expected anytime.
With the re-approval of the Moraiya facility, Zydus will be able to market injectables and nasal products made at this facility in the US.
Zydus had acquired US-based Nesher Pharma in June 2011 to gain foothold into the $ 7 billion controlled-substances market. With the resolution of USFDA issues, Nesher expects to launch new products in the US market during the fiscal.
Zydus' revenue figures touched Rs 5263.31 crore during FY12, up from Rs 4630.59 crore in the previous fiscal.
