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)
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
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 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
The observations are procedural in nature
The objective of launching these products at AAHAR is to create awareness on the consumption of protein based products
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
Biocorp will receive an initial milestone payment this year
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