Breaking News | Shangke Bio: The World’s First NMN Raw Material to Receive FDA NDI Certification
Classification： Company News
Publication：2022-07-23 11:03
Following a rigorous review by the expert committee of the U.S. FDA (U.S. Food and Drug Administration), on May 17, 2022, SyncoZymes (Shanghai) Co., Ltd. officially received an FDA confirmation letter (AKL), confirming that SyncoZymes’ NMN raw material has successfully passed NDI (New Dietary Ingredient) approval.
According to the FDA’s NDI Acceptance Letter, once the 60-day waiting period expires on June 5, 2022, Shangke Bio’s NMN raw material will be officially authorized for use in the production, sale, and marketing of dietary supplements in the United States. Furthermore, starting June 21, 2022, it will be listed as a new dietary supplement on the www.regulations.gov website under registration number 1247.
US FDA NDI Certification
The FDA’s NDI program is a key certification system in the U.S. dietary supplement market. To ensure the safety, label accuracy, and compliance with Good Manufacturing Practices (GMP) in the dietary supplement sector, the FDA officially launched its NDI initiative in 1994.
NDI stands for “New Dietary Ingredients.” Under Section 21 U.S.C. § 350b(d) of the Federal Food, Drug, and Cosmetic Act, if a company believes that a dietary supplement it plans to market contains a new dietary ingredient—defined as an ingredient that was not on the market before October 15, 1994—it must submit a notification to the regulatory authority at least 75 days prior to the product’s launch. The notification must include detailed information about the new ingredient and demonstrate that there is reasonable basis to expect the ingredient to be safe for human consumption.
Each year, more than 5,500 new dietary supplement products are introduced to the U.S. market; however, over the past 28 years since the NDI program was launched, the FDA has accepted fewer than 1,300 NDI notifications. Furthermore, among the NDI submissions filed annually, only 39% receive an “acknowledgment of lack of objection” (AKL) from the FDA.
FDA NDI certification, GMP-compliant manufacturing
Shangke Bio is the world’s first manufacturer to obtain FDA NDI approval for its NMN raw material. This NDI clearance not only signifies the FDA’s official recognition of the safety and quality of Shangke Bio’s NMN ingredient, but also represents the U.S. FDA’s formal endorsement of NMN as a permitted ingredient in dietary supplements in the United States. This is highly positive news for the global NMN industry and will, over the long term, support the continued, standardized development of the sector.
Shangke Bio’s NMN is manufactured in accordance with GMP production standards. To meet rapidly growing market demand, the Group—Zhejiang Shangke Biopharmaceutical Co., Ltd.—began construction in May 2020 on a 230-mu industrialization base for NAD‑related products and chemical drugs. This facility includes a dedicated production workshop designed to achieve an annual NMN capacity of 100 tons, with commercial production scheduled to commence in 2022.
C-end NMN brand – “Xinghe Zhi Mei®”
Shangke Bio owns the consumer‑facing NMN brand “Xinghe Zhi Mei®.” Its NMN products are now available on Tmall Global, JD Worldwide, and the official WeChat cross‑border mini‑program, where they are being sold.
Looking ahead, Shangke Bio will continue to explore the health benefits and underlying mechanisms of natural ingredients, pursue green manufacturing of these ingredients, and deliver scientific, safe, and effective health solutions to humanity. We will remain committed to making unremitting efforts to meet the world’s growing demand for health and well-being.
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