Drug Approval | July 03, 2023
Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
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
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
Single dose of Ferric Carboxymaltose (FCM) up to 750 mg of iron can be infused in 15 minutes
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
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