Eugia's East Windsor facility gets 10 observations from USFDA
The plant is yet to start commercial operations
The plant is yet to start commercial operations
The product is expected to be launched in FY25
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
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
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