Indian nutraceutical manufacturer Zeon Lifesciences has announced it has registered its US facility with the FDA, as well as passed clearance inspections by FDA officials under the FSMA (Food Safety Modernization Act).
The company has also secured NSF certification aligned with 21 CFR Part 111, the FDA's cGMP regulations for dietary supplements.
Zeon said that it would continue to invest in manufacturing systems, quality processes, documentation, testing and regulatory capabilities to support consistent standards across its operations.
The registration and certification mark an important milestone in the company's international expansion strategy, marking it as a reliable nutraceutical manufacturing and CDMO partner for customers.
Suresh Garg, founder and Managing Director, Zeon Lifesciences, said: "Our focus has always been on building manufacturing capabilities that meet global customer expectations."
"Strengthening our US regulatory readiness is an important step in that journey."
We aim to partner with brands that prioritise quality, consistency, transparency and responsible manufacturing, while building the capabilities required to serve regulated international markets.
As part of its international strategy, Zeon said it is strengthening its US-compliant packaging and labelling artwork, finished-product testing, documentation, quality systems and customer support to help partners develop and manufacture nutraceutical products for the US market.
