Nivagen Pharmaceuticals Inc. (Nivagen), located in Sacramento, California, USA has successfully completed the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection. The inspection was closed with zero observations. The inspection was conducted at Nivagen Pharma from March 18, 2024 to March 20, 2024. This inspection covered Nivagen’s PADE surveillance, receipts, evaluations, processing and reporting system for the marketed drug products in the USA. This is Nivagen’s first FDA audit  with zero observations – a testament to Nivagen’s unwavering commitment to ensuring the highest level of patient safety and product quality.

Jay Shukla, CEO, told, “This milestone – FDA audit with zero observations, marks our team’s unwavering commitment to fulfill the manufacturing and regulatory compliance standards.”

With expanding facilities and a dedication to high quality, they aim to enhance access to affordable and cost-effective medicines for patients nationwide.

For more information, please visit www.nivagen.com