Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
The products will be manufactured at the company's facility in Bengaluru
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
The approval bolsters the company's Mycophenolate Mofetil portfolio
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US
Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
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