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.
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
None of the observations are related to data integrity and management believes that they are addressable
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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