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Sinobio has revealed that its fully-owned subsidiary, Chengdu Sinobio Pharmaceutical Co., Ltd., has triumphantly submitted the Drug Master File (DMF) for its tirzepatide Active Pharmaceutical Ingredient (API) to the U.S. Food and Drug Administration (FDA). At present, the DMF filing is active, allowing manufacturers of pharmaceutical formulations to reference it in their own submissions. Tirzepatide, a GLP-1/GIP dual receptor agonist, is prescribed for managing type 2 diabetes, obesity, and moderate to severe obstructive sleep apnea. The completion of this DMF filing is set to bolster the drug's position in the global market. Nonetheless, its sales trajectory will still hinge on various elements, including policy shifts and market dynamics, which introduce a degree of unpredictability.
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