Hot Pursuit     21-Sep-23
Zydus Life gains on receiving USFDA nod for Clindamycin Phosphate Gel
Zydus Lifesciences rose 1.67% to Rs 634.90 after the company received final approval from US Food & Drug Administration (USFDA) for Clindamycin Phosphate Gel.
Clindamycin Phosphate Gel USP, 1% is used to treat acne. It helps to decrease the number of acne lesions. Clindamycin is an antibiotic which works by stopping the growth of bacteria. The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India).

According to IQVIA MAT July 2023, Clindamycin Phosphate Gel USP, 1% had annual sales of $ 37 million in the United States.

As on 30th June 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.

Meanwhile, the company has also received the EIR report from the USFDA for the inspection conducted at the formulation manufacturing facility named ‘SEZ 2' located at Pharmez, Ahmedabad.

The inspection was conducted from 3rd to 7th July, 2023. This was a pre-approval inspection (PAI) and had concluded with NIL observations.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company had reported 109.7% surge in net profit to Rs 1,086.9 crore in Q1 FY24 as compared with Rs 518.3 crore posted in Q1 FY23. Revenue from operations jumped 29.6% to Rs 5,139.6 crore during the quarter as compared with Rs 3,964.4 crore recorded in same quarter last year.

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