Lupin receives tentative approval from USFDA for Selexipag for injection
This product will be manufactured at Lupin's Nagpur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
The inspection of the facility conducted from August 7 to August 11, 2023
Lupin enters into BTA with Lupin Manufacturing Solutions
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
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
Lupin has been exclusively marketing these brands in the Indian market since July 2021
This collaboration marks a significant milestone in countering the disease burden by enhancing access to products for patients in the US
Subscribe To Our Newsletter & Stay Updated