Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release capsules.
Esomeprazole magnesium capsules are used to treat certain stomach and esophagus problems such as acid reflux and ulcers. It relieves symptoms such as heartburn, difficulty in swallowing and persistent cough.
The medication, which belongs to a class of drugs known as proton pump inhibitors (PPIs), helps heal acid damage to the stomach and esophagus and prevent ulcers and cancer of the esophagus.
Esomeprazole capsules, in doses of 20 mg and 40 mg, had annual sales of $395.1 million in the US market.
Glenmark said that it has now 153 products authorised for distribution in the US market and 58 applications pending with the FDA.
Established in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer, Glenmark today has 16 manufacturing facilities in Europe, India and the United States, operating under Good Manufacturing Practices.