Drug Approval | July 05, 2023
Zydus receives final approval from the USFDA for Oxcarbazepine Tablets
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
Supply readiness follows months of manufacturing to ensure timely and ample supply
The company will submit its comprehensive response on these observations to the USFDA
This product will be manufactured at Lupin's Pithampur facility in India
This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable
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