{"id":65981,"date":"2025-03-25T00:02:21","date_gmt":"2025-03-25T00:02:21","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2025\/03\/25\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/"},"modified":"2025-03-25T00:02:21","modified_gmt":"2025-03-25T00:02:21","slug":"abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/","title":{"rendered":"Abinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo\u00aeErgothioneine"},"content":{"rendered":"
\n

SHELTON, Conn., March 24, 2025 (GLOBE NEWSWIRE) — Abinopharm, Inc., an innovative nutritional and biopharmaceutical company, is pleased to announce that their partner company, EGT Synbio, has received no objection letter from the FDA for their GRAS (generally recognized as safe) notification (GRAS Notice No. GRN 001191) of Dr.Ergo\u00aeErgothioneine<\/a>. Abinopharm, Inc. is EGT Synbio\u2019s close collaborator and distributor in the US for their Dr.Ergo\u00aeErgothioneine<\/a>.<\/p>\n

The no objection from the FDA on the GRAS notification of\u00a0Dr.Ergo\u00aeErgothioneine<\/a> is the second such GRAS for ergothioneine in the US. The FDA recognized\u00a0Dr.Ergo\u00aeErgothioneine<\/a>\u00a0as GRAS after reviewing the extensive GRAS notification from EGT Synbio which covered their full enzymatic manufacturing process, superior quality controls, extensive animal toxicity studies (acute toxicity, 90-day chronical toxicity, genotoxicity, and reproductive toxicity), and human clinical trials.<\/p>\n

Dr.Ergo\u00aeErgothioneine<\/a>\u00a0was manufactured using a patented full enzymatic fermentation process under strict cGMP guidance. The manufacturing facility of EGT Synbio was granted NSF GMP certificate and HACCP certificate.\u00a0Dr.Ergo\u00aeErgothioneine<\/a> was certified HALAL. The quality specifications of\u00a0Dr.Ergo\u00aeErgothioneine<\/a> strictly followed ICH guidelines. The purity is >99.9% and optical purity is also >99.9%. Impurities, heavy metals and microbials were all controlled below the limits of USP.<\/p>\n

Ergothioneine is a rare natural amino acid that can be found in many plants, such as mushrooms, beans, etc., in small quantities. It cannot be produced by the human body but is one of the strongest antioxidants that helps clean our cells with excessive ROS (reactive oxygen species), and thus prevent inflammatory recognition loss and other age-related chronic diseases. Humans get this important nutrient from our diet. However, research found that due to oxidative stress or aging, the content of ergothioneine in the human body gradually decreases.<\/p>\n

Lin Yi, CEO of Abinopharm, Inc., said, \u201cDietary supplements containing ergothioneine is an important way to replenish the level of ergothioneine back to normal and increase our healthspan and lifespan. We are very happy to collaborate with EGT Synbio to bring a premium Ergothioneine (Dr.Ergo\u00ae) with FDA GRAS status and human clinically confirmed safety and efficacy to the market.\u201d<\/p>\n

Wei Zhang, CEO of EGT Synbio, said, \u201cWe are extremely excited to collaborate with Abinopharm, Inc. to help market our Dr.Ergo\u00aeErgothioneine<\/a>\u00a0in the US with their technical expertise on nutritional products and knowledge of regulatory compliance and logistics of the US market. Our\u00a0Dr.Ergo\u00aeErgothioneine<\/a> is produced via a full enzymatic fermentation manufacturing process which we licensed from the Chinese Academy of Science. Our patented manufacturing process can produce >99.9% purity of very stable white crystalline ergothioneine. Ergothioneine is a chiral molecule with D- and L-ergothioneine isomers and only L-ergothioneine is bioactive. Our manufacturing process selectively produces L-ergothioneine. Our\u00a0Dr.Ergo\u00aeErgothioneine<\/a> has optical purity of >99.9% L-ergothioneine.\u201d<\/p>\n

About EGT Synbio: EGT Synbio <\/strong>pioneers anti-aging innovation through biology. Its scientific team develops\u00a0clinically validated compounds\u00a0like premium\u00a0Dr.ERGO\u00ae Ergothioneine\u00a0\u2013 a stable, odorless crystal adopted by global brands, holding\u00a0U.S. GRAS, EU Novel Food, and NSF certifications. The 2024 launch of\u00a0EquoPro™ (S)-Equol\u00a0and\u00a0Dr.SPD™ Spermidine Hydrochloride\u00a0expands applications across\u00a0dietary supplements, skincare, and pharmaceuticals, driving next-gen longevity solutions. These\u00a0clinically validated ingredients\u00a0are now\u00a0widely utilized\u00a0across\u00a0food and beverage,\u00a0dietary supplements,\u00a0skincare,\u00a0pharmaceuticals, and\u00a0animal nutrition industries\u00a0\u2013\u00a0empowering products\u00a0from functional foods to\u00a0luxury beauty regimens.<\/p>\n

About Abinopharm, Inc.: Abinopharm, Inc. <\/strong>is an innovative nutritional and biopharmaceutical company located in Shelton, Connecticut, USA centered on developing, regulatory filing, manufacturing, and commercializing novel and premium nutritional and pharmaceutical products in the US and other regulated markets. Our nutritional division focuses on developing premium healthy longevity products by collaborating with world class experts from academic and nutritional industry. Our NMN (AbinoNutra\u00aeNMN) is one of our major healthy aging ingredients which was awarded SA-GRAS status. We have also successfully conducted human clinical trials in collaboration with Professor Andrea Maier to confirm that our AbinoNutra\u00aeNMN is safe and helps with healthy aging. Our portfolio includes other premium healthy longevity ingredients by collaborating with industry leaders: L-Ergothioneine (Dr.Ergo), Fisetin (BeFisetin\u00ae), Urolithin A, CaAKG, Spermidine (Dr.SPD™), S-Equol (EquoPro™), Hydroxytyrosol (olive leave extract), etc. We provide services of regulatory compliance, such as GRAS notification in the US and NPN application in Canada, and private label of high quality and unique dietary supplements that were made in the US, Canada and Europe.<\/p>\n

Contact:<\/strong>
Public Service
Abinopharm, Inc.
info@abinopharm.com<\/a>\u00a0<\/p>\n

\"\"<\/div>\n","protected":false},"excerpt":{"rendered":"

SHELTON, Conn., March 24, 2025 (GLOBE NEWSWIRE) — Abinopharm, Inc., an innovative nutritional and biopharmaceutical company, is pleased to announce that their partner company, EGT Synbio, has received no objection letter from the FDA for their GRAS (generally recognized as safe) notification (GRAS Notice No. GRN 001191) of Dr.Ergo\u00aeErgothioneine. Abinopharm, Inc. is EGT Synbio\u2019s close […]\n","protected":false},"author":1,"featured_media":65982,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-65981","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-people"],"yoast_head":"\nAbinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo\u00aeErgothioneine - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo\u00aeErgothioneine\" \/>\n<meta property=\"og:description\" content=\"SHELTON, Conn., March 24, 2025 (GLOBE NEWSWIRE) — Abinopharm, Inc., an innovative nutritional and biopharmaceutical company, is pleased to annou\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-25T00:02:21+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/english.saigonbiz.com\/vn\/wp-content\/uploads\/2025\/03\/Abinopharm-Inc-.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1\" \/>\n\t<meta property=\"og:image:height\" content=\"1\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"Abinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo\u00aeErgothioneine\",\"datePublished\":\"2025-03-25T00:02:21+00:00\",\"dateModified\":\"2025-03-25T00:02:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\"},\"wordCount\":762,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"People\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/abinopharm-inc-warmly-congratulates-partner-company-egt-synbio-on-receiving-no-objection-letter-from-the-fda-for-their-gras-notification-of-dr-ergoergothioneine\/\",\"name\":\"Abinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo\u00aeErgothioneine - 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