After strict review by the professional committee of the US FDA (US Food and Drug Administration) authoritative organization, on May 17, 2022, SyncoZymes (Shanghai) Co., Ltd. officially received the FDA's confirmation letter (AKL): NMN raw material successfully passed NDI (New Dietary Ingredient) approval.
According to the FDA's NDI acceptance confirmation letter, after the expiration of the silence period on June 5, 2022, SyncoZymes 's NMN raw materials can be officially used in the production, sales, and promotion of health care products in the United States. Also starting June 21, 2022, it can be found on the www.regulations.gov website as a new dietary supplement, number 1247.
About US FDA-NDI certification
FDA NDI is an important certification system for the dietary supplement market in the United States. In order to supervise the safety, label authenticity and production standardization (GMP) in the field of dietary supplements, FDA officially started NDI work since 1994.
NDI is the abbreviation of New Dietary Ingredients. According to the provisions of 21 U.S.C. 350b(d) of the Federal Food, Drug, and Cosmetic Act, if a company believes that the dietary supplements it will launch on the market contain new dietary ingredients (referring to 1994 ingredients that have not appeared on the market before October 15), the company must submit a report to the supervisory authority at least 75 days before the product is on the market, providing details of the new ingredient and proving that there are reasons to expect the new ingredient is safe for the human body to absorb.
More than 5,500 new dietary supplement products are launched in the United States each year, however, in the 28 years since NDI was initiated, the FDA has received less than 1,300 NDI notifications. In the NDI certification applications submitted each year, the FDA no objection response (AKL) pass rate is only 39%.
FDA NDI certification, GMP production system
SyncoZymes is the first manufacturer in the world to obtain FDA NDI approval for NMN raw materials. The approval of this NDI not only represents the approval of the FDA for the safety and quality of NMN raw materials, but also represents the official approval by the US FDA that NMN can be.As a raw material ingredient of dietary supplements in the United States, this is a major positive news for the development of the global NMN industry, and it is also conducive to the continuous standardized development of the NMN industry in the long run.
SyncoZymes' NMN is organized according to a GMP production system. In order to meet the rapidly growing market demand, SyncoZymes (Zhejiang) Co., Ltd.'s NAD series products cover an area of 230 acres. The construction of the chemical drug industrialization base project has started in May 2020, and the well constructed NMN facility has a production capacity of 100 tons. The production workshop is scheduled to start production in 2022.
Retail NMN Brand - "SyncoZymes®"
Syncozymes owns the retail NMN brand, SyncoZymes®. SyncoZymes® NMN products have been launched on Tmall Global, JD.com, and WeChat official cross-border mini programs.
In the future, SyncoZymes will continue to explore the effect and mechanism of natural ingredients on human health, realize the green manufacturing of natural ingredients and provide human beings with scientific, safe and effective health solutions, and will continue to make unremitting efforts to meet the growing global health needs effort!
Post time: Aug-26-2022