Drug Approval | October 01, 2024
Apitoria Pharma gets Form 483 with 10 observations from USFDA
The observations are of procedural in nature and will be responded to within the stipulated time
The observations are of procedural in nature and will be responded to within the stipulated time
The inspection concluded with the issuance of a form 483 with five observations
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
The company will also share results in two additional posters for deuruxolitinib
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