Granules India completes two USFDA audits
image for illustrative purpose
Hyderabad Granules India Limited, a leading vertically integrated pharmaceutical company has completed the U.S. Food and Drug Administration’s (US FDA) Pre-Approval Inspection (PAI) and good manufacturing practices (GMP) audit for their Unit IV facility located at Visakhapatnam, Andhra Pradesh and Jeedimetla facility located at Hyderabad, Telangana with zero observations under the FDA Form 483.
The FDA Form 483 is a report which is sent by the USFDA to highlight any potential regulatory violations. The Vizag facility was inspected by the US FDA on June 36-30, 2023 and the Jeedimetla facility from June 19-23, 2023. The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
“We are proud of the successful completion of the USFDA 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, CMD, 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).
