US regulatory nod for Zydus drug to treat ulcer

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Ahmedabad, July 25 (IANS) Zydus Cadila on Tuesday said it has received final approval of the US Food and Drug Administration (USFDA) for its Mesalamine delayed-release tablets (800mg) to treat a bowel disease that causes inflammation in the digestive tract (ulcerative colitis).

“The drug will be manufactured in our formulation manufacturing plant at Moraiya near Ahmedabad,” a company statement said.

The company has received 27 final ANDA (Abbreviated New Drug Application) approvals and two tentative approvals from the USFDA since January.

“We have 130 regulatory approvals and filed 300 ANDAs since the filing process began in 2003-04,” said the statement.

The city-based global pharma major makes and markets a range of healthcare therapies, employing about 20,000 people worldwide.



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