Innovation

Penglai Ocean's waterless magnesium citrate has passed the US Self-GRAS certification and obtained FDA market access permission.


Published Time:

2025-04-11

Author:

Recently, Penglai Ocean's waterless magnesium citrate has received expert approval for its Self-GRAS (Self-affirmed Generally Recognized As Safe) scientific evaluation conducted in accordance with the US FDA GRAS guidelines.

  Recently, Penglai Ocean's anhydrous magnesium citrate has received expert approval for its Self-GRAS (Self-affirmed Generally Recognized As Safe) scientific evaluation conducted according to the US FDA GRAS guidelines. This means that our company's anhydrous magnesium citrate can be sold and used as a safe food ingredient in the US market, adding a significant endorsement to Penglai Ocean's international journey.

   Safe and Compliant, Globally Recognized

  The SELF-GRAS certification is based on a comprehensive safety assessment covering toxicology studies, metabolic analysis, and process validation, fully demonstrating the safety and compliance of our anhydrous magnesium citrate as a food additive. This is the third time Penglai Ocean has received this certification, following FDA on-site audits in 2012 and 2018, showcasing our brand strength in technological innovation and product quality, and holding significant meaning for the company's high-quality development. To date, over 70% of Penglai Ocean's main product sales are exports, reaching numerous countries and regions in Europe, America, Australia, and Southeast Asia, enjoying a strong reputation and image internationally.

   Core Advantages, Trustworthy

  Anhydrous magnesium citrate is mainly used in the food industry as an acidulant, stabilizer, and nutritional enhancer. It can be used in the production of juices, beverages, and candies to improve the taste and stability of food. Simultaneously, anhydrous magnesium citrate can also serve as a supplement for minerals such as calcium and magnesium, added to dairy products and grain products to enhance their nutritional value. Our anhydrous magnesium citrate boasts high solubility, easily dissolving in water for higher absorption rates; its stable properties, strong hygroscopicity, and secure storage maximize product purity; and the production fineness can be adjusted according to customer needs. Production fully complies with GMP and HACCP standards, with online measurement, real-time monitoring, and rigorous testing throughout the process, ensuring product quality meets national standards, the Chinese Pharmacopoeia, the United States Pharmacopeia (USP), and the British Pharmacopoeia (BP). The recent Self-GRAS certification further validates the quality of this product.

   Market-Oriented, Precisely Matched

  With continuous technological advancements and the pursuit of high-quality living, the application of anhydrous magnesium citrate will continue to expand, and market demand will steadily increase. In the future, our company will focus more on the research of anhydrous magnesium citrate, emphasizing the optimization of its environmentally friendly, safe, and efficient properties to meet broader application needs. Simultaneously, with the continuous development of emerging technologies such as nanotechnology and biotechnology, the preparation methods and application fields of anhydrous magnesium citrate will also see new breakthroughs and development. Our company is a high-tech enterprise integrating the research, development, production, and sales of nutritional enhancers and pharmaceutical intermediates. The company has a professional technical R&D team, achieving customized, unique, and differentiated customer products, creating a leading product chain primarily focused on calcium, magnesium, and zinc nutritional enhancers. The company always adheres to the development concept of technological leadership and pioneering progress, increasing R&D investment in recent years, focusing on technological innovation, and introducing various advanced production instruments. We have achieved high-precision intelligent digital transformation and promoted the implementation of scientific lean management theories.

  Looking to the future, Penglai Ocean will continue to shine in the field of calcium, magnesium, and zinc nutritional enhancers. Obtaining the US FDA GRAS certification is merely a new starting point. Penglai Ocean will continue to advance with greater determination, continuously improving its R&D capabilities and technical level to provide global customers with higher-quality and more reliable calcium, magnesium, and zinc nutritional enhancers, contributing to the development of human health.