PCAS is a leading global supplier of generic APIs to the Pharma and Biotech industries.
PCAS 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 4 cGMP plants located in Europe with a strong track record dealing with international health authorities such as the FDA and Japanese authorities.
PCAS has substantial experience in submitting a broad range of DMF type for active pharmaceutical ingredients.
PCAS 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 PCAS upon request. In addition to submitting regulatory documents in the United States and Europe, PCAS has a strong experience filing regulatory documents throughout the world.
GDUFA: all relevant facilities and sites self-identified PCAS submits several DMF to the FDA Initial Completeness Assessment process. Please refer to our API list to know our DMF available for Reference.
Resources for successful API project development and filing:
Building on over 50 years of experience, 350m3 of cGMP production capacity and a first class R&D with 115 R&D chemists and 7 pilot units, PCAS.
This development and production capability of new APIs is completed with the capacity of being one product source having a worldwide regulatory filing potential.
PCAS can support companies developing products for all markets with the adequate dossier filing and maintenance.
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.
Development of Non-infringing patent and cost competitive process:
PCAS 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.
But our target is not only to be the first but also to last to be part of the long term success of the project, that’s why in addition to patent-free we develop cost competitive products by incorporating original technologies and working on the last array of chemistries where PCAS has a strong knowhow.
In a time of quality uncertainty of raw materials, PCAS 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.
Having several GMP compliance production sites, PCAS can offer an additional level of supply security by offering the possibility of incorporating another site for the API production.
Solid form offer: strong know how on polymorph and customized particle size distribution.
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 PCAS 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 base on our industrial experience on production and also on the excellent network and partnership that PCAS 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.