News | August 29, 2022
Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
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).
Ex-Azithromycin has shown a growth of 8% and 14% in April 2022 and May 2022 respectively
The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
The amalgamation will integrate business operations and provide impetus to the existing portfolio of Alembic
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The Board of Directors of Alembic Pharmaceuticals have approved the unaudited consolidated financial results of the company for the period ended September 30, 2021.
The US business faced price erosion due to increased competition.
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