Active Pharmaceutical Ingredients - Dr Reddy's
Active Pharmaceutical Ingredients - Dr Reddy's

瑞迪博士的61种原料药均采用巴西卫生监督局(ANVISA)认证的良好生产规范(GMP) 药品成分

我们很高兴在巴西联盟官方日记(OFFICIAL DIARY OF THE UNION of Brazil)中宣布,瑞迪博士实验室有限公司的61种瑞迪博士原料药获得了药品成分良好生产规范认证。

该巴西卫生监督局良好生产规范认证覆盖了我们六家生产工厂在巴西市场的所有商业化和正在开发的原料药。.

点击这里查看所有认证的原料药和生产工厂的名单。

这一成就是我们在巴西和印度的药品注册(RA)和质量保证(QA)专家团队共同努力的结果,特别是在遵守巴西卫生监督局发布的最新法规方面。

加上在良好生产规范数量上取得的成就,我们还于2020年准备了31个原料药档案(DIFA),符合原料药档案适当性函( CADIFA) 的合议理事会(RDC)决议第 359/20,还有2021年将准备的33个原料药档案。

我们的拉美药品注册团队的专业知识在于,其所有成员都是由制药行业的前雇员组成的,这让我们对我们的客户和巴西卫生监督局的需求有了更深度的了解。

我们的拉美药品注册/质量保证支持在市场上是无可比拟的,因为我们能够提供各种解决方案,从工厂审计支持、粒径疑难解答、专利地图,亚硝胺、叠氮杂质和其他M7相关杂质的专业知识。

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免责声明

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.

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.