USFDA inspection: Natco Pharma gets 8 observations for Hyderabad Pharma Division
Hyderabad: Natco Pharma Limited has received eight observations from the United States Food and Drug Administration (USFDA) at the end of the inspection at the company's Pharma Division located in Kothur Hyderabad, India.
The inspection was conducted from 9th October, 2023 to 18th October, 2023.
"The company is confident of addressing all the observations within the stipulated time and working with USFDA to close them at the earliest," Natco stated in a BSE filing.
Read also: Natco Pharma net profit rises 31.2 percent to Rs 420.3 crore in Q1
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.
Read also: Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets
