定制合成
概述
AuroSource® is the Custom Research and Manufacturing division of 全球网赌十大网站 Pharma Limited. AuroSource® offers the global bio-tech and pharmaceutical community a refreshing new approach for the outsourcing of chemistry services with a dedicated focus on enhancing value for our customers. AuroSource® offers customer centric project-based chemistry services.
Our team is committed to simplifying the outsourcing experience with exceptional customer service, 在确保透明度的同时, accountability and reliability in terms of cost and delivery. 每个项目都是一种特权, and our team compromise on nothing in order to provide an efficient and unparalleled outsourcing experience.
全球网赌十大网站 Pharma is our parent company and has twenty-two years of experience serving North American, European and Asian markets for over a decade. 全球网赌十大网站 is one of India’s largest pharmaceutical companies with over USD $1 billion in annual sales.
Through its modern development and manufacturing facilities with a dedicated team of Project Managers, R&D和制造人员，AuroSource® offers comprehensive outsourcing options in registered starting materials, 中间体 and APIs along with stability study activities. IP may be granted to customers depending on the type of business agreement entered into at the time a specific project is awarded.
我们的投资组合包括许多专业的R&维能力, 在定制api方面具有特殊的专业知识, 中间体, 开始原料和稳定性研究. We also offer solutions to manage the complete product lifecycle including extensions and regulatory support. 我们有超过1的经验,000份监管文件, export to over 125 countries and have commercialized over 200 products.
服务
AuroSource®‘s contract services cover the clinical stage through to manufacturing and management of the entire drug lifecycle in the API space for Penicillin’s (sterile and non-sterile), cephalosporins (sterile and non-sterile) and non beta lactams. 全球网赌十大网站 believed in the strength of technology and the evolution of science for healthy living since its inception in 1986, 和AuroSource® couples that belief with the commitment to compromise on nothing.
We are committed to executing each and every project in a seamless manner. 全球网赌十大网站’s product breadth and expertise allow us to provide multiple outsourcing benefits to our customers. We offer specialized capabilities with extensive regulatory, and R&D experience from the clinical to the post patent expiry phase of a product.
AuroSource® offers comprehensive outsourcing options in registered starting materials, 中间体 and APIs along with stability study activities. Advance 中间体 and API can be developed and commercially manufactured on an exclusive basis based on a mutually agreeable supply contract.
We foster the development and upscaling of non-infringing routes for our customers. We also offer solutions to manage the complete product lifecycle including extensions and regulatory support.
In stability studies we offer our services for Drug Substance and Drug 产品.
功能
发展
AuroSource® Research is supported by a state-of-the-art R&D division housed in a sprawling 21 acres campus in Pashamylaram, 海得拉巴，建成区面积超过550,5000平方英尺，横跨五层楼. With experience gained in the commercialization of over 200 APIs, the research team is completely attuned to our business needs.
制造服务
AuroSource® offers flexibility with five accredited API development and manufacturing facilities, 大部分都是美国食品和药物管理局的, MHRA, 加拿大卫生部, 矫正性大动脉转位, ANVISA和SA MCC认证. Our ability to make regulatory filings from multiple sites, 加上全球仓储地点, ensures business continuity for our customers with shortened ‘order to delivery’ times.
- In our stability studies offerings we have efficiently implemented global stability protocols 21CFR part 11 compliant LIMS for stability analysis.
- Walk in chambers for all ICH conditions with chamber capacities up to 100,000升, with continuous automated monitoring of all stability chambers.
- State-of-the-art manufacturing facilities bolster our proficiency in GMP and non-GMP processes allowing us to extend a highly competitive edge to each of our customers with API manufacturing needs.
- Our manufacturing services cover your needs from R&D to plant scale material for clinical trials, right up to more specialized capabilities including commercial scale chromatographic separation and lyophilization. We offer six modern scalable facilities with a total reaction volume in excess of 4,500 cubic meters.
项目交付
Through our modern development and manufacturing facilities and a dedicated team of Project Managers, R&D科学家和制造人员, the team is committed to simplifying the outsourcing experience with exceptional customer service, 在确保透明度的同时, accountability and reliability in terms of cost and deliveries. 每个项目都是一种特权, and our team will compromise on nothing in order to provide an efficient and unparalleled outsourcing experience.
Our team is driven to maintain the highest levels of quality, reliability and transparency in order to simplify all aspects of outsourcing with us.
免责声明: AuroSource® is registered in United States Patent and Trademark Office.