Drug Approval | November 09, 2022
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The observation is procedural in nature and the company will address the observation within stipulated timelines.
The CRL did not identify any outstanding scientific issues with the product.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
The inspection concluded with no observation (FDA-483) issued.
The inspection of the facility was conducted from August 16-19, 2022.
The company will address the observations within a stipulated timeline working with the regulators
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