Zhejiang Novus Pharmaceuticals Co., Ltd. was successfully faced the pre-operational visit (POV) conducted by USFDA to Assess the new technology in sterile manufacturing. This was the first time in Asia to conduct the POV by USFDA.  

      Zhejiang Novus Pharmaceuticals Co., Ltd. was formally founded in November 2015, as a wholly owned subsidiary of Zhejiang Medicine Co., Ltd. which is a listed company. Novus is mainly engaged in the development, manufacture and sales of drug products and dietary supplements. During PIND meeting held on July 8th, 2014 for Novus’ Vancomycin for Injection, USFDA was agreed to submit it under 505(b)(2) NDA pathway. On Sept. 15th, 2016, a face-to-face ETT meeting was held at USFDA headquarter and the Agency showed a great interest in continuous aseptic manufacturing technology developed by Novus, accordingly, the Agency proposed to deepen the sharing and exploration of this innovative technology through a POV.

      FDA, known as the authority of the review of international pharmaceuticals, its approval of new drugs is currently considered to be the most advanced, stringent and standardized review in the world. The FDA officials involved in this POV have rich experience in the Pharmaceutical industry,in that senior site auditor has 44 years of experiences in site inspection and other three are PAT (Process Analytical Technology) inspectors. During the POV, Novus and FDA made a comprehensive and in-depth discussion on innovative technologies and processes, such as aseptic spray drying, aseptic transfer of sterile bulk powders and aseptic filling. Although FDA inspectors have strict  requirements on review and approval of a new drug product, showed positive and full affirmation on Novus’ innovative technology and process. This POV not only help FDA inspectors understand Novus’ innovative technologies and processes, but also provide Novus a good opportunity to demonstrate innovative technologies, processes, manufactures and controls.

      Novus shell start the manufacturer of the high-quality drug products  immediately after getting approval from the FDA by using advance technology that are developed in-house to offer solutions for increasing medicine induced diseases globally and contribute to establish a strong support in protecting and enriching the human health.