Novacap is a leading global supplier of generic APIs to the Pharma and Biotech industries such as Oxybutynin, Troxerutine, Timolol Maleate, Pholcodine, Esomeprazole Magnesium, Baclofen or Ketamin.
Novacap, through its subsidiaries PCAS and Uetikon, has over 35 years of experience in developing and producing high-quality Active Pharmaceutical Ingredients using first class R&D and proprietary technology such as biocatalysis to develop unique processes.
More than 50 APIs have been successfully launched in the United States, Europe and Japan with consistently superior quality, reliability and customer service, supported by regulatory documentation to meet the most stringent standards from local agencies.
Customers will benefit from a dependable manufacturing network of 5 cGMP plants located in Europe with a strong track record dealing with international health authorities such as the FDA and Japanese authorities.
Novacap files regulatory document such as CEP, Drug Master File (DMF) or Active Substance Master File (ASMF). These documents contain the relevant details of the manufacturing process enabling competent authorities (e.g. FDA, EMA) to review process information in support of third party drug product marketing applications. A letter of authorization/access that will allow the relevant authorities to review the DMF will be provided by Novacap upon request. In addition to submitting regulatory documents in the United States and Europe, Novacap has a strong experience filing regulatory documents throughout the world. This possibility is enabled by an in-house Regulatory Affairs team and a total of 30 Quality Assurance staff taking care of more than 80 active regulatory dossiers worldwide.
Novacap has an in-house IP team for the design of non-infringing patent process to assure the customer the freedom to operate on the target market at the desired launch.
In a time of quality uncertainty of raw materials, Novacap has the adapted non-GMP sites to put in place a back integration of critical raw material and Regulatory Starting Materials in order to ensure our customers a supply security without depending on third parties for advanced intermediates controlling the cost of this security at the same time.
The solid form of an API is a critical point for the success of a new API project both from IP and technical point of view.. Over the years Novacap has built a strong know-how on polymorphs for identification and the process to prepare them on a stable and reproductive manner. This know-how is based on our industrial experience on production and also on the excellent network and partnership that Novacap has put in place on this field. We additionally offer to our customers the convenience of working together during development a customized particle size distribution for the success of the new API project.
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