Phenylalanine

Phenylalanine is one of the 8 essential amino acids for the human body, belonging to aromatic amino acids. It cannot be synthesized in the human body on its own and needs to be ingested through diet or supplements. Its core physiological functions are to participate in protein synthesis and the precursor transformation of neurotransmitters. It can be converted into tyrosine, which is then used to synthesize important signaling molecules such as dopamine and norepinephrine. It is also a raw material for the synthesis of melanin and thyroxine. At the clinical level, phenylalanine is a core component of amino acid drugs and formula foods for special medical purposes, especially suitable for people with insufficient protein intake other than patients with phenylketonuria, and patients requiring postoperative nutritional support. It can also be used as a nutritional supplement for chronic consumptive diseases.

The global market size of amino acid API has exceeded 32 billion US dollars in 2023, among which the annual compound growth rate of medicinal-grade phenylalanine is maintained at around 5.2%. The current market supply is dominated by enterprises from China, Japan and South Korea, and China's production capacity of medicinal-grade phenylalanine accounts for 47% of the global total production capacity. Driven by the expansion of the formula food for special medical purposes industry and the increase in the purchase volume of compound amino acid preparations under the centralized procurement policy in recent years, the domestic demand for medicinal-grade phenylalanine increased by 8.7% year-on-year in 2023. At present, there are 12 domestic enterprises that have been approved to produce phenylalanine API, the competition pattern is relatively scattered, and no single enterprise has a market share of more than 15%.

As a basic medicinal amino acid, there is no clear original research enterprise for phenylalanine. According to the domestic API registration platform, there are 9 domestic phenylalanine APIs that have obtained A-status registration numbers, and there are no valid A-status registration numbers for imported APIs. The domestic marketed preparations containing phenylalanine are mainly compound amino acid injections, special amino acid formula preparations for children and formula foods for special medical purposes. Both phenylalanine API and related preparations have been included in the National Medical Insurance Catalog. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for phenylalanine, most of which are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers in quality research, impurity benchmarking and declaration.