Drug Approval | November 22, 2023
Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
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 Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
Lupin enters into BTA with Lupin Manufacturing Solutions
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
India has the highest prevalence of diabetes globally, with an estimated 77 million people living with the condition and an expected 134 million cases by 2045
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
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