Ahmedabad: Torrent Pharma has recently announced that the Company has received a Form 483 with one observation from the US Food and Drug Administration (USFDA) at the end of the pre-approval inspection at the Company’s Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat.

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.

The inspection was conducted from 13-Mar-23 to 17-Mar-23.

“At the end of the inspection, we have been issued a “Form 483” with 1 observation, which is procedural in nature. We will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observation at the earliest,” the Company informed in a BSE filing.

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.

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