USFDA completes inspection at Baddi facility of Aarti Drugs’ arm

23 Apr 2024 Evaluate

United States Food and Drug Administration (USFDA) has concluded inspection at Aarti Drugs’ Subsidiary -- Pinnacle Life Science’s Formulations (Oncology) manufacturing facility located at Baddi, Himachal Pradesh. USFDA conducted inspection from April 16, 2024 to April 22, 2024. 

On conclusion of the inspection, the company has received 5 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. 

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.

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