Drug Approval | October 19, 2022
USFDA visit to Alembic Pharmaceuticals Panelav facility
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Availability of pharmaceutical-grade materials with broad API compatibility key to advancing drug delivery solutions
The inspection of the facility was conducted from August 16-19, 2022.
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
The policy aspires to reduce cost of logistics in India to be comparable to global benchmarks by 2030
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The intelligent connected bed is one of the most significant breakthroughs in India’s journey to create a world-class connected healthcare system to deliver quality healthcare to a billion Indians.
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
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