Drug Approval | November 04, 2023
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
Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
The product is being launched in August 2023
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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