Drug Approval | March 09, 2024
Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility
The inspection was concluded with few procedural observations
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
Eugia Pharma Specialities restarts production at terminally sterilized product lines
The observations do not pose any risk to site's compliance standards or its business continuity
Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully
IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China
The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
US FDA approval based on NEURO-TTRansform Phase III results
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Laurus Synthesis receives Form 483 with 5 observations from USFDA
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