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Lupin gets USFDA nod for Cefprozil

Our Bureau

Mumbai , Dec. 22

LUPIN Ltd has received regulatory approval in the US for its Abbreviated New Drug Application (ANDA) for antibiotic Cefprozil oral suspension.

The company said that its different dosages of Cefprozil, a generic equivalent of Bristol Myers Squibb's Cefzil, received the approval from the US Food and Drug Administration (USFDA). The suspension market in the US is $119 million, according to industry data. Earlier this month, the company received approval from the USFDA for Cefprozil tablets.

Lupin's Chairman, Dr D.B. Gupta, said that tablets and the suspension would contribute to the product's success and together the Cefzil brand clocks in at $236 million.

Lupin expects to capture a profitable market share post patent expiry on December 23. This is Lupin's 10th ANDA approval by the USFDA till date and the fifth in this financial year.

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