Comments
Granules India’s US subsidiary has received two observations from the US health regulator following the completion of inspection.
“Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US, has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations,” the company said in a BSE filing.
Granules Pharmaceuticals Inc will respond to the observations within this week, the company added.
As per the USFDA, Form 483 is issued to a company management at the conclusion of an inspection when the investigator observes that any conditions in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts.
“This was a prior approval inspection intended for the abbreviated new drug application filed by Granules Pharmaceuticals Inc. This facility is involved in the development and manufacturing of finished dosages,” the company said.
The company’s shares were trading up 8.75 per cent at Rs 100.10 on the BSE.
Comments
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 TheHindu Businessline 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.