Business Companies 21 Feb 2019 Zydus receives USFDA ...

Zydus receives USFDA nod for 2 products

PTI
Published Feb 21, 2019, 4:23 pm IST
Updated Feb 21, 2019, 4:27 pm IST
The company has received final approval from the United States Food and Drug Adminstration (USFDA) to market generic Phytonadione tablets.
The product is used to prevent or treat attacks of gout, it added. (Photo: File)
 The product is used to prevent or treat attacks of gout, it added. (Photo: File)

New Delhi: Drug firm Zydus Cadila on Thursday said it has received approvals from the US health regulator for its Phytonadione tablets and Colchicine tablets.

The company has received final approval from the United States Food and Drug Adminstration (USFDA) to market generic Phytonadione tablets USP in the strength of 5 mg, Zydus Cadila said in a statement.

 

The product is used to treat and prevent low levels of blood clotting factors that the body naturally produces when caused by vitamin K deficiency or interference with vitamin K activity, it added.

The group also received the final approval for generic Colchicine tablets USP, 0.6 mg, Zydus Cadila said

The product is used to prevent or treat attacks of gout, it added.

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

The group now has 250 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.

 

Shares of Cadila Healthcare, the listed entity of the group were trading at Rs 313.50 per scrip on the BSE, down 0.03 per cent from the previous close.

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Location: India, Delhi, New Delhi




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