Drug Approval | March 23, 2024
Briefs: Concord Biotech and Neuland Laboratories
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
It is the first autotaxin inhibitor to be investigated in cancer patients
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.
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