With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company
The inspection concluded with no observations
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company has been issued ‘Form 483’ with two observations
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
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