Sinotherapeutics, Inc. is a pharmaceutical company that specializes in the research, development, manufacturing, and commercialization of complex generic formulations, high-barrier oral drug delivery systems, and contract development and manufacturing organization (CDMO) services. Founded in 2012 and headquartered in Shanghai, China, the company operates integrated research facilities and cGMP-compliant manufacturing infrastructure through key subsidiaries, including Zhejiang Sinotherapeutics Pharmaceuticals Co., Ltd., catering to domestic healthcare channels as well as international markets across the United States, Europe, and the Asia-Pacific region.
The company's business activities are structured into proprietary pharmaceutical product development and contract technical services. Its primary commercial and development portfolio focuses on challenging formulations such as solid dispersions, insoluble drug solubilizations, and sustained- or controlled-release oral solid dosages. Core products include Posaconazole Delayed-Release Tablets, an antifungal therapeutic marketed in both the United States and China; Tofacitinib Citrate Extended-Release Tablets, indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis; Brivaracetam Oral Solution and Tablets, indicated for the management of partial-onset seizures; Nifedipine Controlled-Release Tablets, utilized in cardiovascular indications including hypertension and chronic stable angina; Metoprolol Succinate Sustained-Release Tablets, developed for hypertension and heart failure management; and Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, formulated for type 2 diabetes mellitus control. Under its CDMO and CRO business lines, Sinotherapeutics delivers end-to-end technical solutions to global pharmaceutical clients, including pre-formulation assessment; formulation design and optimization; analytical method development and validation; stability studies; clinical trial material batch manufacturing; and commercial-scale pharmaceutical production adhering to US FDA, EU GMP, and China NMPA standards.
In recent operations, Sinotherapeutics has advanced its commercial strategy through international regulatory approvals and targeted market expansions. The company has secured successive Abbreviated New Drug Application (ANDA) clearances from the US FDA and market authorizations from China's NMPA for several of its complex generic and extended-release formulations, facilitating new product commercial launches in North America and China. To accelerate international market penetration, Sinotherapeutics has formed strategic distribution, licensing, and commercialization partnerships with multinational pharmaceutical enterprises. Additionally, the company has expanded and upgraded the production capacity of its advanced manufacturing facilities in Zhejiang Province to scale its proprietary commercial output and accommodate an increasing volume of high-potency and complex formulation CDMO contracts from biopharmaceutical partners worldwide.