Roquette to acquire Qualicaps from Mitsubishi Chemical Group
Qualicaps is the third largest producer of hard capsules for oral dosage solutions
Qualicaps is the third largest producer of hard capsules for oral dosage solutions
Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
This product would be manufactured at Lupin's Nagpur facility in India
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