Aurobindo Pharma has received final approval from US Food and Drugs Administration (USFDA) to manufacture and market Esomeprazole Magnesium Delayed-release Capsules USP, 20mg and 40mg. The launch of this product is based on the settlement terms/litigation outcome with AstraZeneca. The approved ANDA is bioequivalent to the reference listed drug product Nexium Delayed-release Capsules, 20mg and 40mg, of AstraZeneca Pharmaceuticals.
Esomeprazole Magnesium Delayed-release Capsules is used in the treatment of gastroesophageal reflex disease. The approved product has an estimated market size of $ 4.2 billion for 12 months ending February 2016 according to IMS.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments. The firm provides semi-synthetic penicillins that have a presence in therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
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