Aurobindo's product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The product is being launched in August 2023
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
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
The company has been issued ‘Form 483’ with two observations
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