In SUANFARMA ‘s industrial division, we are committed to offering comprehensive solutions that allow our clients to reach all their challenges for rapid access to the market and improve the lives of patients. To this end, we offer our CDMO capacity for fermentation and chemical synthesis projects, offering a “One Stop Shop” service with a solid track record, and which allows to achieve success in the development, scaling, manufacturing, and commercialization of an API, either innovative or generic. We bring our experience, methodology and knowledge to our customer’s projects from the development to the commercial phase.
Our team of professionals works every day to ensure that our processes are rigorous and that our SOPs (standard operating procedures) are followed to achieve the required quality, maintaining the sustainability of the business and offering the best service to our customers.
We offer complete Project Management, in order to deliver individualized solutions that support our customers from the beginning to the end of the product manufacturing chain.
Our goal is to offer a fast and flexible service following the highest quality standards that allow our customers reduce market entry times.
SUANFARMA has two factories in Europe whose facilities allow us to adapt to the requirements of our partners, both in fermentation processes and chemical synthesis.
We have a large R&D team and the necessary capabilities to support our clients during the development process of their products. We have one of the largest fermentation facilities in Europe that ranges from laboratory and pilot plant to industrial scale, and various technologies for the purification of molecules. In our factories we develop any chemical synthesis process on a pilot or industrial scale, since we have the necessary elements to carry out complex reactions, hydrogenations, distillations, LL and SL phase separations, crystallizations and isolation of intermediates and finishes by centrifugation, Nutsche filtration, as well as drying in rotary vacuum equipment, fluid bed dryers and static dryers.
ADVANCED TECHNOLOGY TRANSFER
SUANFARMA is highly committed to supporting its customers, which is why our teams focus on providing solutions to the difficulties that may arise during the development of a molecule. The industrial division has developed an innovative Technology Transfer Policy, thus maximizing the chances of success in achieving the objectives of our customers and minimizing risks during the early phases of the project.
This innovative platform, registered under the name of TT&GO®, follows a rigorous and systematic methodology based on quality criteria and allows us to apply our GMP manufacturing knowledge in technology transfer processes. In addition, it helps to ensure the industrialization of any type of process in our factories and allows the commercialization of the final product in the market quickly and efficiently.
PROVEN FULL SCALABILITY
We offer our CDMO customers alternatives and solutions adjusting to the needs of each project. After years of experience in the industry and having worked on the development of our own molecules, the workers at our facilities have the necessary experience to ensure an understanding of the possible challenges and difficulties that occur both in the early stages of the development of a molecule as in the scaling and commercialization phase of the process.
SUANFARMA has a proven track record in commercial development and manufacturing, having worked with more than 28 small molecules and more than 18 CDMO customers from different countries. The scalability of our technologies is proven, and our regulatory experts advise customers in the preparation of scaling strategies with the Medicines Agencies of the different regulated countries worldwide.
AND QUALITY CONTROL
At SUANFARMA we are guided by strict quality standards during all phases of production, from the selection of raw materials to manufacturing. Our facilities apply the cGMP regulations and are regulated by international quality standards, in addition, both customer audits and international authorities are carried out.
In the Industrial division we have a very demanding quality control during all stages, from the development of analytical methods to the control of the manufacturing process, from the inspection of incoming materials to the release and continuous stability tests of finished products.
In addition, SUANFARMA offers its CDMO customers the experience of our Quality Assurance team, which is made up of a team of professionals in charge of the management and preparation of Registries and Dossiers for the most demanding regulated markets in the world.
At SUANFARMA we strive to work guaranteeing the safety of our employees and the protection of the environment. The company has an important commitment to meet our sustainability goals: limiting the environmental impact of our actions, pollution prevention, proper waste management, efficient use of resources to save energy and water, and adoption of environmentally friendly materials.
OF OUR FACILITIES
The SUANFARMA Group is in continuous expansion of its facilities and staff. To reach the high demand for manufacturing capacity, we have invested in an expansion plan for one of our facilities, which will include three new DSP lines for purification activities of fermentative processes, which allows us to continue growing in CDMO service capacity, in number of projects and requests.
SUANFARMA is a solid and reliable partner for your routine manufacturing.
R & D
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