Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Dr. Fesharaki most recently served as the Chief Scientific Officer and Global Head of R&D for Hikma Pharmaceuticals.
The product will be manufactured at Lupin's facility in Nagpur, India.
The inspection concluded with no observation (FDA-483) issued.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
Ensitrelvir is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days.
Construction is now underway with the facility scheduled to be operational by 2025
The inspection of the facility was conducted from August 16-19, 2022.
Department and Industry Associations to organize 3 days National Level Expo on Indian Medical Devices Sector at Pragati Maidan, New Delhi between 9-11 Dec 2022, first of its kind expo in India
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