Biocon  

Biocon Limited has informed that the US Food and Drug Administration (USFDA) conducted a surveillance inspection of our API facility (Site 1), located at Bengaluru, Karnataka, between the 16th to 20th September 2024. Three observations were cited at the end of the Inspection, which the company will be addressing within the stipulated time. The company does not foresee any impact on the business.

Aarti Drugs

Aarti Drugs Limited has informed that the United States Food and Drug Administration (USFDA) has inspected the API manufacturing facility of its company at Plot No. E-22, MIDC, Tarapur, Maharashtra from 12th - 20th of September, 2024. On conclusion of the inspection, the company has received seven inspectional observations in Form 483, where none of the observations are related to data/integrity. The company will work closely with the USFDA in resolving all points.

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations after an inspection at the company’s formulation manufacturing facility based out of Chhatrapati Sambhaji Nagar, Aurangabad, India between 9th - 20th September, 2024.