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Daridorexant Hydrochloride is the API form of daridorexant, a dual orexin‑receptor antagonist for adult insomnia treatment. It blocks orexin‑A and orexin‑B binding to OX1 and OX2 receptors to reduce wake‑promoting signals, helping patients fall asleep and maintain sleep without disrupting normal sleep architecture. It appears as white‑to‑light‑yellow powder with poor water solubility. Its finished‑drug brand name is Quviviq, approved by FDA in 2022 for insomnia characterized by sleep‑onset and sleep‑maintenance difficulties. This molecule attracts growing attention for generic formulation and registration projects worldwide.

RECARBRIO (Relebactam) for Injection is a fixed-dose combination antibiotic indicated for serious Gram-negative infections, including hospital-acquired pneumonia, complicated urinary tract infections, and complicated intra-abdominal infections. Each 1.25 g vial contains imipenem, cilastatin, and ralibactam. Ralibactam protects imipenem from degradation by serine β-lactamases and restores its activity against resistant pathogens. Approved in the US (2019), EU (2020), and launched in China (2020), this Class 4 chemical drug is not yet domestically approved in China. We offer full-process formulation development and technology transfer services, with the sterile ralibactam API currently in the validation stage.

This study aims to develop a novel cocrystal form of Trofinetide to circumvent the existing crystalline patent (valid until 2042). The research begins with comprehensive solid-state and solubility characterization of the starting material, followed by computational prediction of pharmaceutically acceptable cocrystal ligands. Systematic screening is performed using both dry and solvent-based methods, including grinding, slurry, and evaporation techniques. Promising cocrystals are optimized, characterized by PXRD, DSC, TGA, and DVS, and evaluated for stability under stress conditions. Additionally, single-crystal cultivation is pursued to confirm the cocrystal structure. The total project duration is estimated at six months.