Glenmark Pharma gets 7 observations from USFDA for Baddi unit
New Delhi: Glenmark Pharmaceuticals said the US health regulator has made seven observations after an audit at its Baddi manufacturing unit.
Glenmark said its Baddi unit contributes approximately 10 percent of the revenue of the US sales.
"The Baddi unit of Glenmark Pharmaceuticals underwent a US FDA (US Food and Drug Administration) audit from November 6 -11, 2017. The USFDA issued seven observations through the form 483," Glenmark Pharmaceuticals said in a BSE filing.
"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations," it added.
The company, however, did not elaborate on the nature of observations.
7 observationsauditBaddiBaddi unitFDAform 483GlenmarkGlenmark PharmaGlenmark Pharmaceuticalsindian pharma newsmanufacturing unitobservationspharma newspharma news indiarevenueUS Food and Drug AdministrationUS salesUSFDA
Source : PTINext Story
NO DATA FOUND
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd