Hyderabad: Natco Pharma Limited has announced the successful completion of United States Food and Drug Administration’s (USFDA) inspection of the firm’s compliance to Pharmacovigilance requirements with zero observations.
NATCO’s Pharmacovigilance Department, at its Corporate Office in Hyderabad, was inspected from October 30, 2023 to November 1, 2023.
“The Pharmacovigilance procedures of NATCO for its products marketed globally and particularly, in USA, were inspected and found to comply with USFDA’s requirements,” the Company informed in a BSE filing.
Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company’s focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.
Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.