The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
PM emphasises the need to enhance lab surveillance & testing of all Severe Acute Respiratory Illness (SARI) cases & ramp up genome sequencing
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
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)
The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland
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
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