Drug Approval | March 22, 2023
Granules Consumer Health concludes FDA audit with zero observations
The audit is a pre-approval inspection for three products filed from the facility
The audit is a pre-approval inspection for three products filed from the facility
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
This loan is in addition to earlier announced CAD 25 million loan committed by the Province of Quebec
Biocorp will receive an initial milestone payment this year
ALPLA is expanding its presence in the global market for pharmaceutical packaging by establishing a joint venture with Inden Pharma
Dr. Hubbard brings more than 35 years of experience in the biopharmaceutical and pharma-tech services industries and CROs.
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