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We have two fully operational R&D facilities and an API manufacturing plant under construction:
We have two research and development facilities for complex APIs and formulations in Israel and Nanjing, China. The two R&D sites (Ness-Ziona, Israel and Nanjing, China) are engaged at various aspects of our chemistry and pharmaceutical development. The Israeli site is focused on novel process research & development for our highly complex APIs, as well as laboratory “proof of concept” development and pilot scale pharmaceutical development. Our technical teams have experience in optimizing existing processes and developing new or second generation safe and environmentally sound routes. Our late stage development team has extensive experience in the following: commercial synthesis route scouting, commercial process development and optimization through Design of Experiments and Quality by Design for the pharmaceutical products portfolio via defining critical process parameters and impurity profiling. Our Chinese facility is focused on kilo-lab scale production of advanced intermediate for the pilot scale production. Integrating the two facilities eliminates the need for tech transfers when a project advances through each development phase, allowing us to help reduce time to market while providing consistent and cost-effective APIs. In addition to our complex API development arm, we are engaged in the development of complex dosage forms, mainly parenterals and orals. The parenteral route of delivery includes our once-monthly depot formulation of Glatiramer Acetate and the oral route includes our existing pipeline of complex value added generics.
Our Israeli development and manufacturing plant in the industrial park Neot Hovav, Israel, is a chemical synthesis facility, designed for the production of APIs and intermediates. The plant is expected to be operational during 2016. The plant is designed as a multipurpose facility with mid-size industrial production reactors of varying capacities of up to 4,000 liters. The plant’s scalable design should enable us to expand capacity with limited expenditures. The plant is expected to hold two pilot facilities for smaller scale production to support the production scale-up process and initial sales of registration quantities.