Zydus bags USFDA nod for acne gel Clindamycin Phosphate

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

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).

Clindamycin Phosphate Gel USP, 1% had annual sales of USD 37 mn 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.

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Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg).

Read also: Zydus Lifesciences receives USFDA approval for severe cystic acne drug Isotretinoin

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.