Tianjin Pharmaceutical wins China approval for histidine API
November 12, 2026
Source: drugdu
24
Tianjin Pharmaceutical (600488) announced on the evening of November 11 that China’s National Medical Products Administration had approved its marketing application for histidine active pharmaceutical ingredient (API). The application was submitted and accepted in November 2024, and supplementary materials were filed from December 2025 to March 2026. China’s Center for Drug Evaluation lists the API as status A, indicating approval for use in marketed formulations. The company invested approximately RMB 1.47 million in the project.
Histidine is an essential amino acid used in amino acid infusions and combination formulations. The filing cited IQVIA data showing that global sales of oral and injectable formulations containing histidine, including single ingredient and combination products, were US$2.223 billion in 2024 and US$2.131 billion in 2025. Before the approval, the company had 25 amino acid APIs in its domestic portfolio.
Source: https://finance.eastmoney.com/a/202611123928798819.html
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