Drug Approval | July 13, 2024
Lupin receives EIR from USFDA for its Dabhasa facility
The facility is a part of Lupin Manufacturing Solutions
The facility is a part of Lupin Manufacturing Solutions
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
This product will be manufactured at Lupin’s Pithampur facility in India
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
The facility was inspected from May 7 to May 17, 2024
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
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