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15-Jul2017
The US Food and Drug Administration (USFDA) has conducted an inspection at Alkem Laboratories' Bioequivalence facility located at Taloja in state of Maharashtra from July 10, 2017 to July 14, 2017. At the end of the inspection, no Form 483 was issued.
Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.
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Alembic Pharmaceuticals (Alembic) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acetazolamide Extended-Release Capsules, 500......