Jubilant Ingrevia Receives Clean Bill of Health from USFDA Inspection

Jubilant Ingrevia Limited (JUBL), a leading manufacturer of speciality chemicals, has achieved a significant milestone by receiving a clean bill of health from the United States Food and Drug Administration (USFDA). This accomplishment signifies the successful outcome of a recent inspection conducted at JUBL’s Unit-1 manufacturing facility in Bharuch, Gujarat, India, in April 2024.

The USFDA inspection focused on evaluating JUBL’s adherence to Current Good Manufacturing Practices (CGMP) regulations – a critical benchmark for ensuring the quality and safety of manufactured products intended for human consumption. The inspection report, referred to as an Establishment Inspection Report (EIR), is the culmination of this process. JUBL is proud to announce that the EIR contained zero inspectional observations (Form 483 observations), indicating full compliance with US FDA regulations.

This achievement underscores JUBL’s unwavering commitment to maintaining the highest quality standards throughout its manufacturing processes. The existing Bharuch (Unit-1) facility is already compliant with GMP regulations, and an ongoing expansion forms part of JUBL’s strategic capital expenditure plan. This expansion will further strengthen JUBL’s position to cater to the growing demand in the nutraceutical, dietary active ingredient, cosmetic, and drug intermediate markets. Additionally, the facility will be equipped to manufacture Contract Development and Manufacturing Organization (CDMO) products intended for both industrial applications and human consumption.

JUBL’s successful US FDA inspection paves the way for its foray into the lucrative and highly regulated US market. This achievement will allow JUBL to expand its product portfolio and reach a wider customer base, solidifying its position as a global leader in speciality chemicals.

“We are pleased to share that our manufacturing site, Unit-1, intended for the manufacturing of Nutraceuticals & Dietary- Active ingredients for Human consumption in a GMP-compliant facility located at Bharuch, Gujarat, India, has successfully undergone its maiden USFDA inspection with the outcome of zero 483 inspectional observations. This accomplishment reiterates our Company’s unwavering commitment to maintaining the highest quality and compliance standards. It is also a testament to our entire team’s dedication and capability to achieve a common objective that reinforces our leadership position in delivering safe, effective and high-quality compliant products to our customers,” said Mr Deepak Jain, CEO and Managing Director, Jubilant Ingrevia Limited.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.