Granules API, formulations facility in Vizag completes U.S. FDA inspection  

Published - April 13, 2024 08:03 pm IST - HYDERABAD

Granules India’s Unit V facility in Visakhapatnam that manufactures APIs and formulations of oncology and non-oncology products

Granules India’s Unit V facility in Visakhapatnam that manufactures APIs and formulations of oncology and non-oncology products | Photo Credit: Special arrangement

Drugmaker Granules India’s Unit V manufacturing facility in Visakhapatnam has completed an U.S. Food and Drug Administration inspection.

It was a pre-approval inspection (PAI) and cGMP audit for APIs and formulations for oncology and non-oncology products. The unit successfully completed the U.S. FDA inspection, conducted from April 8-12, resulting in zero Form 483 observations, the company said. “Proud to reiterate that our focus on high-quality standards is comparable to the best global benchmarks as we receive zero observations from U.S. FDA audit,” CMD Krishna Prasad Chigurupati said in a release on Saturday.

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in

Comments

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.