Drug Approval | November 04, 2022
Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Lenalidomide is used to treat various types of cancers.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
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