USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
The inspections concluded with no Form 483 observations or significant critical findings
The inspections concluded with no Form 483 observations or significant critical findings
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
The company is committed to address this observation comprehensively within stipulated time
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