Novugen Pharma Malaysia Achieves Zero Kind 483 Citations in Latest USFDA Audit

Bandar Enstek, Malaysia, October 29, 2024 –(PR.com)– Novugen Pharma Sdn. Bhd. is happy to announce the profitable completion of a surveillance inspection audit carried out by the U.S. Meals and Drug Administration (USFDA) from twenty first to twenty fifth of October 2024. The corporate proudly studies that it accomplished the five-day audit with zero Kind 483 citations and no deficiencies.

In accordance with the surveillance inspection, Novugen demonstrated a state of fine management from a Good Manufacturing Follow (GMP) compliance perspective. Attaining the standing of NAI (No Motion Indicated) is a big milestone for Novugen, representing the best stage of compliance attainable by any USFDA-registered manufacturing facility. This distinctive accomplishment, alongside the zero Kind 483 citations, positions Novugen amongst a choose few international corporations that meet this customary.

“We’re extremely happy with this achievement, which displays the relentless dedication, arduous work, and tradition of steady enchancment fostered by your complete Novugen group in sustaining the best requirements in pharmaceutical manufacturing,” mentioned Rahil Mahmood, Chief Government Officer of Novugen. “This milestone reinforces our place as a trusted participant within the international pharmaceutical business.”

The audit isn’t solely a regulatory requirement for Novugen’s continued operations within the USA, but it surely additionally underscores the corporate’s dedication to high quality and the strategic investments made in Malaysia to thrive in extremely regulated markets. High quality is embedded in Novugen’s DNA, enabling the corporate to confidently showcase its energy, resilience, and dedication to excellence.

Novugen stays devoted to delivering high-quality pharmaceutical merchandise and advancing healthcare options that profit sufferers all over the world.