Drug Approval | December 27, 2021
Lupin receives U.S. FDA approval for Sevelamer Carbonate
This product will be manufactured at Lupin's Goa facility in India
This product will be manufactured at Lupin's Goa facility in India
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
Under this scheme, the company will make a committed investment in plant and machinery, get incentives on incremental sales of pharmaceutical products
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
The tablets are indicated for the treatment of pulmonary arterial hypertension
Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever
The product will be commercialized from Unichem's Ghaziabad plant
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