facebook twitter linkedin

This material was prepared by a third party towards Selvita S.A. with its registered office in Kraków (hereunder: “Selvita”). Within the scope which was not authorized by Selvita’s management board, the description of factual circumstances regarding the activities of Selvita, embodied in this material presents merely opinion of the third party, in particular with respect to presented opinions, predictions, appraisals and forecasts of the financial data and future activity of Selvita and its results.

Therefore, Selvita does not warrant consistency of this material with the actual and legal situation. Neither Selvita, members of its corporate bodies, employees nor its consultants shall bear any liability for validity of opinions, predictions, appraisals, forecasts and any other date embodied in this material as well as for consequences of actions of any reader made on a basis of this material, in particular for the investment decisions or any losses resulting from use of this material.

Readers of this material shall make its own assessment, whether opinions or forecasts embodied therein are credible and adequate, in particular taking into account their investment strategy and actual and legal situation. In particular they should consult it with their independent financial and investment advisors. None of the information presented in this material shall constitute investment, legal, accounting or tax advice or a statement that any investment strategy is accurate or adequate, considering the circumstances of the reader.

Furthermore date presented in this material shall not constitute an offer to sell or purchase any financial instruments nor an invite the make such offer. It shall not be also not deemed as a recommendation for investment in any financial instrument nor an advertisement of such instruments.



DISAGREE AGREE

Selvita Group and Polfa Warszawa announce commencement of a collaboration concerning the analytical work necessary to prepare the registration dossier for a medicinal product. 

 

The scope of the project, commissioned to Selvita Group, includes development, validation and transfer of analytical methods for characterizing substances resulting from the degradation product of a complex formulation. Due to the intricacy of the project, studies will require the use of non-standard, highly specialized analytical techniques. 

"We are delighted that a company with such a rich history, experience and reputation as Polfa Warszawa decided to use our services - said Dr. Milosz Gruca, Director of Research and Development, a Board Member of BioCentrum which belongs to the Selvita Group. We hope that our cooperation will expand in the future, so that Polfa Warszawa will be able to concentrate on its core activities related to the production of drugs, and Selvita Group will be able to support it in the field of research and development.

"We hope that this will be the beginning of a long collaboration, which will allow us for prompt preparation of registration dossiers. This way we will be able to deliver new products to the market faster, for the benefit of patients." - said Ms. Karolina Pokorowska, Spokesperson for Polfa Warszawa SA 

The project covered by the agreement is implemented for the preparation by Polfa Warszawa of a medicinal product registration. All tests performed by the Selvita Group will be carried out in accordance with the requirements of the European Medicines Agency. Results of the work will be prepared in the CTD format, allowing Polfa Warszawa to directly use them in the documentation submitted to the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products . 

 

 

Selvita Group is an innovative Polish company providing research and development services and IT solutions. We deliver comprehensive solutions for pharmaceutical and research companies targeted at lowering the cost of bringing products to market. The group also includes BioCentrum, which has been audited and qualified by the General Pharmaceutical Inspectorate in the field of therapeutical substance manufacturing for the physicochemical analyses of the substances and their certification.  BioCentrum’s offer includes services in chemical analysis (eg. development, validation and transfer of methods of API analysis, stability testing, dissolution profiles), protein chemistry (incl. analysis of amino acid composition and sequencing), in vitro preclinical studies (ADME) crystallography, and enzyme production. 

Polfa Warszawa SA is one of the largest and most known Polish pharmaceutical companies. Polfa Warszawa SA manufactures 140 formulations, which are exported to over thirty countries. Polfa Warszawa is a leading manufacturer of hospital drugs and cardiac preparations. Upper respiratory track clearing medicines, drugs  produced by Polfa represent nearly half the domestic market. Currently the company is at the selection stage of an investor who will finalize the ongoing privatization process.