Torrent Pharma gets USFDA OAI status for Gujarat facility

Published On 2023-01-24 09:44 GMT   |   Update On 2023-01-24 09:44 GMT
Advertisement

AhmedabadTorrent Pharma has announced that the Company has received a communication from the US Food and Drug Administration (USFDA) determining the inspection classification of the manufacturing facility at Indrad, Gujarat as “Official Action Indicated” (OAI).

Official Action Indicated (OAI) which means regulatory and/or administrative actions will be recommended.

"This inspection classification will not have impact on existing supplies or revenues from this facility. Torrent Pharma continues to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator," Torrent stated in a BSE filing
Advertisement
"Torrent Pharma remains committed to being cGMP compliant quality standards across all its facilities," the company added.

Medical Dialogues team had earlier reported that the USFDA had issued a "Form 483" with 3 observations at the end of the inspection at Torrent Pharma's manufacturing facility at Indrad, Gujarat.

Torrent Pharma is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. The company specializes in the therapeutic segments of cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology, and anti-infective segments. The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.

Read also: Torrent Pharma to buy Curatio Healthcare for Rs 2,000 crores

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News