Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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
The inspection of the facility was conducted from August 16-19, 2022.
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
The company will address the observations within a stipulated timeline working with the regulators
Lenalidomide is used to treat various types of cancers.
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
Veda Corporate Advisors was the exclusive financial advisor to SHPL and its shareholders.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
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