Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Therapy recently approved in Canada under the brand name KORSUVA
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022
Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.
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