Drug Approval | January 24, 2023
USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
None of the observations are related to data integrity and management believes that they are addressable
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
Most of the new growth Capex investments are happening on the Specialty Chemicals and Nutrition side
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
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