The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The JUST 100 is the only ranking that recognizes companies doing right by all their stakeholders as defined by the American public.
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
Moderna and Merck announced mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a 44% reduction in the risk of disease recurrence or death in melanoma patients
The centre has initiated next generation sequencing (NGS) as a tool for undertaking studies on genomic epidemiology of pathogens
He urged the dignitaries to collaboratively work on the identified domains of improvement and make detailed reports on them
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
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