Drug Approval | July 29, 2024
Briefs: Indoco Remedies and Alembic Pharmaceuticals
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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
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