US drug regulator revokes warning to Cadila Healthcare

Ahmedabad, July 17, 2012: After issuing a warning letter to the Ahmedabad-based Cadila Healthcare Ltd in June last year citing non-conformity with its norms at the Moraiya facility, the US drug regulator, United States Food and Drug Administration (USFDA) has recently revoked its warning. The company said in a statement that the warning issue is now resolved.


It is expected that the company will now see a rise in the filings and approvals of injectables from its Moraiya facility. In fact, since the facility has cleared the safety norms, the oral dosage products (which were blocked due to the warning letter) will be approved soon. Market experts are of a view that a large number of approvals will come through in the short term.


It is expected that these approvals will help will help in driving the US generic sales from the second half of FY 2012-13 for the company.


Keeping in mind that Cadila is chasing an ambitious growth target of $3 billion in revenue by 2015, the USFDA approval will support in paving the way for the Indian pharma major. For the record, it earned Rs. 5,181 crore in revenue during 2011-12. The company is expecting to drive revenue growth from both domestic and overseas operations, and from various divisions such as formulations, active pharmaceutical ingredients (inputs to make formulations), wellness, and animal health.


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