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.
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
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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