Custom Synthesis
Overview
AuroSource® is the Custom Research and Manufacturing division of Aurobindo 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, while ensuring transparency, accountability and reliability in terms of cost and delivery. Every project is a privilege, and our team compromise on nothing in order to provide an efficient and unparalleled outsourcing experience.
Aurobindo Pharma is our parent company and has twenty-two years of experience serving North American, European and Asian markets for over a decade. Aurobindo 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 and manufacturing personnel, AuroSource® offers comprehensive outsourcing options in registered starting materials, intermediates 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.
Our portfolio includes many specialized R&D capabilities, with particular expertise in customized APIs, intermediates, starting raw materials and stability studies. We also offer solutions to manage the complete product lifecycle including extensions and regulatory support. We have experience in over 1,000 regulatory filings, export to over 125 countries and have commercialized over 200 products.
Services
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. Aurobindo believed in the strength of technology and the evolution of science for healthy living since its inception in 1986, and AuroSource® couples that belief with the commitment to compromise on nothing.
We are committed to executing each and every project in a seamless manner. Aurobindo’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, intermediates and APIs along with stability study activities. Advance intermediates 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 Products.
Capabilities
Development
AuroSource® Research is supported by a state-of-the-art R&D division housed in a sprawling 21 acres campus in Pashamylaram, Hyderabad with a built-up area of over 550,000 square feet across five floors. With experience gained in the commercialization of over 200 APIs, the research team is completely attuned to our business needs.
Manufacturing Services
AuroSource® offers flexibility with five accredited API development and manufacturing facilities, most of which are USFDA, MHRA, Health Canada, TGA, ANVISA and SA MCC accredited. Our ability to make regulatory filings from multiple sites, coupled with global warehousing locations, 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 litres, 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.
Project Delivery
Through our modern development and manufacturing facilities and a dedicated team of Project Managers, R&D Scientists and manufacturing personnel, the team is committed to simplifying the outsourcing experience with exceptional customer service, while ensuring transparency, accountability and reliability in terms of cost and deliveries. Every project is a privilege, 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.
Disclaimer: AuroSource® is registered in United States Patent and Trademark Office.