United States Food and Drug Administration (USFDA) has conducted Pre-Market Inspection covering USFDA’s Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) at the Gland Pharma’s Pashamylaram Facility at Hyderabad from August 23, 2023 to August 26, 2023.
The company has received 2 observations on Form 483 with respect to ANDA filed for the product to be manufactured in a PEN device at the said Facility. There is no data integrity observation.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
