Granules India completes USFDA audit at Visakhapatnam facility with zero 483 observations
Hyderabad: Granules India Limited, a vertically integrated pharmaceutical company, has completed the U.S. Food and Drug Administration’s (US FDA) Pre-Approval Inspection (PAI) and GMP audit for their Unit IV facility located at Visakhapatnam, Andhra Pradesh, India with zero 483 observations.
Recently, Granules India’s Jeedimetla facility located at Telangana, Hyderabad, India also successfully completed the US FDA’s surveillance inspection with zero 483 observations.
Read also: USFDA successfully concludes inspection at Granules India Jeedimetla facility
The Vizag facility was inspected by the US FDA from 26th June to 30th June, 2023 and the Jeedimetla facility from 19th June to 23rd June, 2023.
“We are proud of the successful completion of the US FDA surveillance inspections at our Vizag and Jeedimetla facilities with zero observations. This achievement is a testament to our unwavering commitment to quality and compliance. It reinforces our position as a trusted and reliable global pharmaceutical manufacturer." said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India.
The Unit IV facility located at Visakhapatnam manufactures Active Pharmaceutical Ingredients (API) and the Jeedimetla facility manufactures Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates (PFIs).
Read also: Granules India bags USFDA nod for Hypertension drug Metoprolol Succinate ER
Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain — from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300 plus customers in regulated and semi-regulated markets with a global presence extending to over 80 plus countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
Read also: Granules India bags USFDA nod for Hypertension drug Metoprolol Succinate ER
