SSY GROUP (02005) has announced that it has obtained the drug production registration certificate from China's National Medical Products Administration (NMPA) for its Gadobutrol Injection (7.5ml: 4.5354g). This approval falls under Category 4 of chemical drugs and is deemed equivalent to passing consistency evaluation.
The Gadobutrol Injection is intended for diagnostic purposes and is administered exclusively via intravenous route. It is suitable for adults and children of all ages, including full-term newborns, and is primarily used for contrast-enhanced magnetic resonance imaging (CE-MRI) of lesions throughout the body, including the brain and spinal cord, as well as for contrast-enhanced magnetic resonance angiography (CE-MRA) across various body regions.
The company's Gadobutrol Active Pharmaceutical Ingredient (API) has already been registered with the NMPA for use in marketed formulations. As a next-generation macrocyclic MRI contrast agent, Gadobutrol further enriches the company's diagnostic and therapeutic product portfolio.
Gadolinium is a rare earth metal, and this injection approval solidifies the integrated business layout combining gadolinium-based APIs and injectable formulations. This move helps expand the company's presence in the medical imaging clinical market and creates business synergies with its existing formulations.
Additionally, SSY GROUP has obtained NMPA approval for Indocyanine Green for Injection (25mg), classified as Category 3 chemical drugs and deemed equivalent to passing consistency evaluation. This product is primarily used for diagnosing various liver diseases, including cirrhosis, liver fibrosis, chronic hepatitis, and occupational or drug-induced toxic liver disease, helping to assess the degree of liver damage and reserve function. It is also indicated for choroidal angiography to determine the location of choroidal disorders.
The company's Indocyanine Green API has also been registered with the NMPA for use in marketed formulations. The approval of this injectable powder further improves the company's product layout for perioperative and ICU critical care departments. Leveraging its integrated advantage in APIs and formulations, the company aims to expand into the top-tier hospital surgical and critical care medical markets, creating synergistic effects with its existing critical care formulations.
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