Drug Approval | September 20, 2023
Briefs: Caplin Steriles, Zydus and APL Healthcare
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
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
Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
The product is expected to be launched in June 2023
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