Guolong Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Indocyanine Green API
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发布时间:2025-09-10
【概要描述】
On September 9, the indocyanine green API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms. This marks the 16th new API product approved for the Group so far this year and the 7th new product approved for Guolong Pharmaceutical.
On September 9, the indocyanine green API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed pharmaceutical preparations. This marks the 16th new API product approved for the Group so far this year and the 7th new product approved for Guolong Pharmaceutical.
According to available information, indocyanine green is primarily used for the diagnosis of various liver diseases, including hepatic cirrhosis, hepatic fibrosis, chronic hepatitis, and occupational and drug-induced hepatotoxicity, to assess the extent of liver damage and evaluate hepatic reserve function; it is also employed in choroidal angiography to localize choroidal lesions.
In recent years, the Group has been market-demand driven, fully leveraging its own strengths and those of its innovation consortium to actively advance an integrated “API–formulation” development strategy, gradually establishing a virtuous innovation cycle characterized by “developing a batch, translating a batch, and stockpiling a batch.” Currently, the Group boasts a portfolio of 83 bulk and specialty API products. Through a three-dimensional strategic layout—driven by breakthrough innovations in APIs, stable support from bulk APIs, and differentiated development of specialty APIs—the Group continues to strengthen its competitive edge in the API sector. The rapid growth of the API business segment has become a key pillar for the company’s high-quality expansion, creating a synergistic “dual-wing” effect with the formulation business.
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