The need for hot-melt extrusion (HME) polymers is expected to grow as the pharma industry moves to implement more continuous and sustainable processes.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
The product will be manufactured at Lupin's facility in Nagpur, India.
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The ANDA was filed as 'First to File' submission on NCE-1 date.
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
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