Drug Approval | July 24, 2023
Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Aurobindo will respond to the US FDA within the stipulated timelines
Aurobindo will respond to the US FDA within the stipulated timelines
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
The product is expected to be launched in June 2023
Venkat Nageswar Chalasani has been appointed as an Independent Director of Apitoria Pharma with effect from April 4, 2023
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
Revenue from operations during the quarter was up by 6.7 per cent to Rs 6,407.10 crore against Rs 6,002.2 in the same period last fiscal.
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)
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