Granules India gets EIR from USFDA for Vizag OmniChem facility
New Delhi: Drug firm Granules India said it has received Establishment Inspection Report (EIR) from the US health regulator for the OmniChem facility at Vizag, Andhra Pradesh.
OmniChem facility is operated by 50:50 joint venture of Granules India and Ajinimoto OmniChem N V, it said in a filing on BSE.
The United States Food and Drug Administration (USFDA) has issued EIR for the company's OmniChem facility, it added.
"This facility was inspected by the USFDA in December 2016 and there were seven observations during the inspection. The facility manufactures Active Pharmaceutical Ingredients (API) intermediates," Granules India said.
active pharmaceutical ingredientsAjinimoto OmniChem N VAndhra PradeshEIREstablishment Inspection ReportGranules Indiajoint ventureOmniChem facilityseven observationsUSFDAVizag
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