近日，FDA官网更新了礼来和诺和诺德原研注射制剂的短缺目录状态，由"Limited Availability"变为"Available"。这一变化引发了市场对美国药房自配制剂（Compounding）需求减弱的担忧，进而影响了国内GLP-1原料药相关公司的业绩预期。然而，中信证券的最新分析报告指出，这一变化并未对GLP-1原料药需求的中长期逻辑造成实质性影...
——美国药房Compounding市场需求主要分503A和503B两类，根据FDA规定，503A不能进行大批量生产，503B可以进行批量生产（根据美国503B药房参与者Hims and Hers官网数据，公司平台私人定制减肥产品的年度订阅用户数量预计年底达到100万人；根据司美格鲁肽的剂量方案，我们预计单个503B药房的GLP-1原料药需求在公斤级别），FDA...
诺和诺德发出最新一轮进攻,要求 FDA 阻止配药商生产其糖尿病和肥胖症治疗药物 Ozempic 和 Wegovy(索马鲁肽),称这些药物过于复杂,无法配制。 10 月 22 日,诺和诺德提议将索马鲁肽列入 FDA 的可证明难以配药(Demonstrable Difficulties for Comp...
诺和诺德发出最新一轮进攻,要求 FDA 阻止配药商生产其糖尿病和肥胖症治疗药物Ozempic和Wegovy(索马鲁肽),称这些药物过于复杂,无法配制。 10 月 22 日,诺和诺德提议将索马鲁肽列入 FDA 的可证明难以配药(Demonstrable Difficulties for Compounding,DDC)清单。诺和诺德在其提议中写道,“索马鲁肽产品属于这一清单,因为其配...
By the time this podcast [episode] airs, I think it will have been a month or so since our podcast [episode] on GLP-1 compounding has aired and the challenges that arise from compounding. Compounding is used for a lot of drugs that are in shortage, which many of these medications a...
”1For example, drugs may be compounded under 503A for pediatric or elderly patients who require liquid dosing or patients who may be allergic to an inactive ingredient and need a different formulation. 503A compounding is typically performed at a pharmacy by a licensed pharmacist, pursuant to a...
——替尔泊肽和司美格鲁肽原研制剂在FDA官网的短缺目录中的状态更新,并不代表已经移除短缺目录,Compounding市场业务目前暂仍可正常进行;诺和诺德在2024Q2业绩会上说明,小剂量(0.25 mg/0.5 mL)的司美格鲁肽(Wegovy)2024年内仍预计为短缺状态。 ▍司美格鲁肽口服(Rybelsus)剂型销售超预期,口服推升GLP-1原料药需求确...
GLP-1 (Oral) Get startedLearn more Ozempic® Get startedLearn more Zepbound® Get startedLearn more❯ Compounded GLP-1s are not FDA-approved and are sourced from licensed compounding pharmacies. We’ve got you covered with over 20,000 clinicians across all 50 states.25...
各玩家的工艺路径不同,加之各国对工艺路径不同而注册申报类别存在差异,所以原料药/中间体玩家们各凭本事开发的制剂合作方也有差异,从原研药客户、ANDA(例如505j)客户、到Compounding(503A/B)客户以及COPP路径上市的(东南亚/中东等市场)客户,百花齐放,各自精彩。
美国复方行业倡导组织Alliance for Pharmacy Compounding首席执行官Scott Brunner认为，复方药制造商在履行合法处方方面发挥着关键作用，不应与非法销售商混为一谈。Hims & Hers等公司声称，即使当某些药物从FDA短缺清单中移除，他们仍可以继续销售复方药。他们援引《联邦食品、药品和化妆品法》的某些条款，认为只要对药物...