2020年4月
瑞迪博士是最早发起全面审查的原料药制造商之一,以确保通过设计避免亚硝胺杂质的出现,并确保其分析方法符合监管机构制定的未来严格限制。
瑞迪博士在《仿制药公报》(Generics Bulletin)2019年度全球仿制药和生物仿制药奖上荣获“年度原料药供应商”奖,并因其以积极和系统的方法解决了沙坦原料药 的亚硝胺杂质问题而受到赞扬。 (如 缬沙坦).
在本文中,瑞迪博士北美和欧洲原料药区域主管杰什·萨达南丹解释道,那些有着以患者为重文化的制药公司、原料药供应商和配料制造商通常是最适合去进行预测和应对这些挑战的,这最终将增加获得高质量药物和改善患者健康。”
点击这里阅读全文:
您也可以点击此处阅读我们的白皮书“满足沙坦原料药生产的新监管要求”:
https://api.drreddys.com/white-paper/meeting-new-regulatory-requirements-sartan-api-production-0
No information on this website, including any reference to any product or service constitutes an offer for sale or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.