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Zydus Cadila has received the US health regulator’s approval for marketing the mesalamine tablets that is used in treating uclerative colitis.
The company has said in a BSE filing that the USFDA has given its final approval to market mesalamine delayed-release tablets USP 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for the generic version of Lialda (mesalamine).
The company is going to manufacture the product at its Moraiya facility in Ahmedabad.
