Hot Pursuit     08-Jun-23
Zydus Life gets USFDA nod for acid reflux and ulcer drug
The drug major on Thursday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Esomeprazole Magnesium for delayed-release oral suspension.

The said drug is equivalent to reference listed drug (RLD), Nexium delayed-release for oral suspension.

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. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers and is expected to help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

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

According to IQVIA MAT April 2023, Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of $42 million the United States.

As of 31 March 2023, 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.

Separately, the drug maker said that it has also received final approval from the USFDA for Tadalafil tablets. The said drug is equivalent to RLD, Adcirca tablets. Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. It is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

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

The company's consolidated net profit (from continuing operations) tumbled 27.55% to Rs 298.8 crore despite of 31.66% jump in total revenue from operations to Rs 5,010.6 crore in Q4 FY23 over Q4 FY22.

Shares of Zydus Lifesciences were down 0.18% to Rs 514.05 on the BSE.

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