Zydus gets USFDA final nod for Clindamycin Phosphate Gel

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Gel USP, 1% (USRLD: Cleocin T Gel, 1%), the company informed on Wednesday.

Zydus said that Clindamycin Phosphate Gel USP, 1% is used to treat acne and it helps to decrease the number of acne lesions. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

Further, the drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).

Clindamycin Phosphate Gel USP, 1% had annual sales of USD 37 million in the United States (IQVIA MAT July 2023).

The group now has 381 approvals and has so far filed over 444 ANDAs since the commencement of the filing process in FY 2003-04, the company stated.

On Thursday, at around 10:05 AM, shares of Zydus Lifesciences were under pressure and trading lower by 1% at Rs618 per share on the BSE.