Drug Approval | January 19, 2023
USFDA completes inspection at APL HealthCare
The company has been issued ‘Form 483’ with two observations
The company has been issued ‘Form 483’ with two observations
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
The product is expected to be launched by Q4 FY23.
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
The drive also conducted a mega health camp, cancer screening for women and men, ENT screening for children, and blood donation drive
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The company has reported total income of Rs. 6276.54 crores during the period ended June 30, 2022.
The company has a total sales of Rs. 25.8 crore during FY 21-22 and Rs. 26.4 crore during FY 20-21.
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