The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
The company will engage with the agency to resolve the import alert at the earliest.
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 company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
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 drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
The company will respond to these observations within the stipulated time period.
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