USFDA issues 2 observations for Strides Pharma Science subsidiary Chennai facility
Bengaluru: Strides Pharma Science Limited has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has issued two observations after a routine current Good Manufacturing Practices (cGMP) inspection at the Formulations Facility of Strides Alathur Private Limited, a wholly-owned subsidiary of the Company, at Alathur, Chennai.
USFDA inspected the facility during the week of April 1, 2024 to April 5, 2024.
comprehensively to FDA within the stipulated time,” Strides added.
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor‐ funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries.
Read also: Strides Pharma Science Singapore arm gets USFDA okay for fibromyalgia drug Pregabalin
