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28
2024
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06
EDQM granted CEP certificate for our L-Leucine
Author:
On June 25, 2024, the good news came. Yichang Sanxia Proudin Biopharmaceutical Co., Ltd. received the CEP certificate of L-Leucine API issued by EDQM. This is the second CEP certificate of amino acid API obtained by the company within half a year after the L-Isoleucine API CEP certificate.
L-Isoleucine and L-Leucine are essential amino acids, often used as nutritional supplements. They are widely used in amino acid injection, culture medium, infant formula, dietary supplements, FSMP, etc.
Fermented L-Isoleucine and L-Leucine are the key products of our company. The company attaches great importance to the continuous optimization of critical process, and emphasizes the improvement of product quality and compliance construction. The L-Isoleucine and L-Leucine produced by our company can not only meet different standards of USP / CP / EP / food grade, but also meet special requirements of downstream customers to produce customized high-end products in different application fields.
The CEP certificate indicates that L-Isoleucine and L-Leucine API meet the specification of EP. It also marks the company's R&D level, production level, quality management level and RA level have stepped into a new level, laying a solid foundation for the company's core products to enter the high-end pharmaceutical regulatory market.
The international registration of other amino acid and other advantageous products are also in progress. The company will, as always, leverage our technical and quality advantages in the field of amino acid to develop more excellent and more suitable products and better customer service.
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