Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
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 facility was inspected from May 7 to May 17, 2024
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
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