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
Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).
This product will be manufactured at Lupin's Nagpur facility in India
Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus
Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The product is being launched in August 2023
Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
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