Caplin`s Generic Ketorolac Tromethamine Receives Approval in the U.S.
Enforcement Report - Week of December 6, 2023
Aspiro's Generic (Ketorolac Tromethamine) Receives Approval in the U.S.
Enforcement Report - Week of June 7, 2023
Caplin's Generic Ketorolac Tromethamine Receives Receives Approval in the U.S.
Enforcement Report - Week of January 25, 2023
Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials.
Alembic's Generic Ketorolac Tromethamine Receives Approval in the U.S.
Two domestic drug manufacturers were lambasted in recent warning letters sent by the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) violations; one was told to adopt better contamination controls and to keep outsourced drugs separate from those made at the facility, while another was reprimanded for keeping the facility in a poor state of repair.
Zydus' Generic Ketorolac Tromethamine Receives Approval in the U.S.