USFDA issues EIR for Torrent Pharma Bileshwarpura facility

Ahmedabad: Torrent Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the Oral- Oncology manufacturing facility at Bileshwarpura, Gujarat and the inspection has now been successfully closed by the USFDA.

USFDA had inspected the said facility from 13-March-23 to 17-March-23 and issued a Form 483 with one observation. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Read also: Torrent Pharma gets 1 USFDA observation for Bileshwarpura facility

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. Torrent Pharma has a widespread global presence in over 40 countries.

Read also: Torrent Pharma unveils generic version of Keveyis tablets in US