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06
2023
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12
EDQM granted CEP certificate for our L-Isoleucine
Author:
On December 01, 2023, our company received the European Pharmacopoeia Suitability Certificate for Isoleucine APIs issued by the European Medicines Quality Agency (EDQM) (Hereinafter referred to as the CEP Certificate). It indicates that the API meets the quality requirements of the European Pharmacopoeia, shows the recognition and affirmation of the quality of the API in the European standardized market, marking that the API product can be sold in the European market and other standardized markets that recognize the CEP certificate, and has a positive impact on the company to further expand the international market.
Isoleucine is an essential amino acid (one of the three branched chain amino acids), often used as a nutritional supplement, widely used in infant formula milk powder, dietary supplements, special medical food, amino acid injection, culture medium, polypeptide drugs and other fields.
Our company began to produce fermented amino acid products in 1974, with more than 30 independent intellectual property rights. Isoleucine is one of the key products of our company. The isoleucine raw materials produced by our company have versions that meet different standards such as food grade /USP/CP/EP, and can produce customized high-end products according to the special requirements of downstream customers in different application fields, such as low phenyl-propylene version, double standard(CP+EP) and high purity products.
The quality standards required by CEP are higher than those of the Chinese Pharmacopoeia CP in terms of impurity control, and have more stringent requirements for specific impurities in isoleucine API products. Our company can optimize the fermentation source strain formula, control the extraction process, and systematically study the factors affecting the quality attribute of the product, so that the product quality can reach the level above EP under the control of the cost.
The CEP registration of our other amino acid APIs is also continuing. The company will continue to play the technical advantages in the field of amino acid fermentation and the concept of continuous improvement of product quality system, further expand the product line, increase investment in research and development and international registration, in order to achieve more innovation and market breakthroughs, so that customers continue to obtain satisfactory products and services.
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