Drug Approval | November 20, 2023
Lupin receives approval from US FDA for Ganirelix Acetate Injection
The product will be manufactured at Lupin’s Nagpur facility in India
The product will be manufactured at Lupin’s Nagpur facility in India
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
The products will be manufactured at the company's facility in Bengaluru
The products will be manufactured at the company's facility in Bengaluru
The approval bolsters the company's Mycophenolate Mofetil portfolio
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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