Drug Approval | October 02, 2024
Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
The inspection conducted by EDQM at its Visakhapatnam facility
He holds a Master’s in Management from the National University of Singapore
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The inspection concluded with the issuance of a form 483 with five observations
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
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