USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
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
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