U.S. Food and Drug Administration (USFDA) has concluded inspection at Aarti Drugs’ API manufacturing facility located at Tarapur, Maharashtra. On conclusion of the inspection, the company has received 7 inspectional observations in Form 483, where none of the observations are related to Data Integrity. The company will work closely with US FDA in resolving all points.
There is no impact on financial, operation or other activities of the Company pursuant the observations received. USFDA conducted inspection from September 12, 2024 to September 20, 2024.
Aarti Drugs is engaged in the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharma Intermediates, Specialty Chemicals and also produces Formulations with its wholly-owned subsidiary - Pinnacle Life Science.
