USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA
The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
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