Zydus receives final approval from USFDA for esomeprazole magnesium

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for esomeprazole magnesium for delayed-release oral suspension, 20 mg and 40 mg, the company said in a BSE filing on Thursday.

Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux and ulcer). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough.

In a regulatory filing, the company said, “This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers and is expected to help prevent cancer of the esophagus.”

Shares of Zydus Lifesciences Ltd, on Thursday, marginally rises at Rs 514.20 on BSE.

Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Esomeprazole magnesium for delayed-release oral suspension, 20 mg and 40 mg had annual sales of $42 mn in the United States.

The group now has 370 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.

In May, Zydus Lifesciences Ltd reported a 25.36 per cent decline in consolidated net profit at Rs 296.6 crore in the fourth quarter ended March 31, 2023 impacted by impairment of goodwill of a wholly-owned subsidiary.

The company, which had posted a consolidated net profit of Rs 397.4 crore in the same quarter of the previous fiscal, said its board has recommended a final dividend of Rs 6 per equity share of Re 1 each, subject to approval of shareholders at the Annual General Meeting scheduled to be held on August 11, 2023.

Consolidated total revenue from operations stood at Rs 5,010.6 crore, as against Rs 3,805.6 crore in the corresponding period a year ago, Zydus Lifesciences said in a regulatory filing.

Total expenses were higher at Rs 3,961.3 crore, as compared to Rs 3,311.8 crore in the year-ago quarter.

During the quarter, Zydus Lifesciences said it incurred an exceptional item of Rs 594.1 crore as impairment of goodwill by Sentynl Therapeutics Inc, a wholly-owned subsidiary of the group.