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Zydus Cadila gets USFDA nod to market generic Lansoprazole tablets

Press Trust of India  |  New Delhi 

Drug firm Thursday said it has received final nod from the US health regulator to market generic tablets used for treating conditions caused by stomach acid.

The final approval from the Food and Drug Administration (USFDA) is to market delayed release orally disintegrating tablets in the strengths of 15 mg and 30 mg, said in a statement.

The product "will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad," it added.

tablets are used for the treatment of conditions such as ulcers, (GERD) and that are caused by stomach acid, said.

The company has also received tentative approval from the USFDA for generic tablets in the strength of 5 mg, it added.

tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.

The product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it added.

The group now has 236 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.

Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 347.50 per scrip on the BSE, up 1.39 per cent from their previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, November 29 2018. 13:35 IST