Isotretinoin capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (such as benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). The said drug is equivalent to reference listed drug, Accutane capsules.

The pharma company said that the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.

According to IQVIA MAT July 2023, Isotretinoin capsules had annual sales of $165 million in the United States.

The group now has 378 approvals and has so far filed over 444 ANDAs since the commencement of the filing process in FY 2003-04.

“Section 505-1 of the FD&C Act authorizes FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) for this product. Zydus' proposed REMS has also been approved by FDA. The Isotretinoin iPLEDGE REMS consists of Elements to Assure Safe Use (ETASU) and an implementation system,” the company stated in the press release.

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

The pharma company 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.

Shares of Zydus Lifesciences were down 0.31% to Rs 626.20 on the BSE.