First FDA NDI Approval for Chinese NMN Ingredients
Jun 02, 2022
On May 17, Syncozymes Biopharmaceuticals (Shanghai) Co., Ltd (hereinafter referred to as "Syncozymes") officially received the confirmation letter (AKL) from the FDA, confirming that Syncozymes' NMN ingredients have successfully passed the NDI (New Dietary Ingredient) approval. (New Dietary Ingredient) approval.
According to the FDA's NDI acceptance letter, Syncozymes' NMN ingredient will be ready for use in the production, marketing and promotion of nutraceuticals in the United States after the expiration of the silent period on June 5, 2022.
NMN is known as β-nicotinamide mononucleotide. NMN can be rapidly converted to NAD+ after entering the body, compensating for the decline in NAD+ content caused by aging.
NDI, which stands for New Dietary Ingredients, is an important certification system for the U.S. dietary supplement market. According to 21 U.S.C. 350b(d) of the Federal Food, Drug, and Cosmetic Act, if a company believes that a dietary supplement it will introduce to the market contains a new dietary ingredient (which is an ingredient that has not appeared on the The company must submit a report to the Oversight Board at least 75 days prior to the introduction of the product, providing detailed information on the new ingredient and demonstrating that it is reasonable to expect that the new ingredient is safe for human absorption.
The approval of NDI not only represents the FDA's official recognition of the safety and quality of NMN raw materials, but also represents the FDA's official approval of NMN as a dietary supplement ingredient in the U.S. This is a significant good news for the development of the global NMN industry, and is also beneficial to the standardized development of the NMN industry in the long run.
Syncozymes covers an area of 230 acres for the industrialization base of coenzyme NAD series products and chemical drugs in May 2020, which is designed to have a special production plant of NMN with a capacity of 100 tons/year.
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