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20 December 2024

Polpharma has opened the first center in Poland for the development and production of highly active pharmaceutical ingredients (HP API).

Polpharma has opened a new specialized center in Starogard Gdański, dedicated to research and development, as well as the production of highly active pharmaceutical ingredients (HP API), used in the manufacturing of drugs, including oncology medications. This investment, valued at over 100 million PLN, is the only one of its kind in Poland and one of the few in Europe. This positions Polpharma at the forefront of HP API manufacturers worldwide.

Technology, safety, and products of the highest quality

The state-of-the-art technologies and high standards of the center will enable the development and production of substances that help patients fight diseases such as cancer, multiple sclerosis, and spinal muscular atrophy (SMA).

The first substances to be produced at the newly opened facility are:

  • Trametinib: used in the treatment of melanoma and non-small cell lung cancer.
  • Vismodegib: intended for the treatment of basal cell carcinoma.

In the near future, the following will be developed:

  • Ozanimod: used in the treatment of multiple sclerosis and inflammatory bowel disease.
  • Risdiplam: a drug for spinal muscular atrophy (SMA).

The center was established with the highest safety standards for employees and the environment in mind. The laboratory equipment includes the best-in-class safety technologies to protect workers from exposure to highly active substances, in the form of isolators, as well as additional collective (secondary) protection solutions.

The importance of the investment for drug security

Currently, about 80% of the world’s API production takes place outside Europe, mainly in Asia. In Poland, out of approximately 400 molecules subject to reimbursement, only about 3% come from domestic production. Polpharma’s investment aims to increase local production capacities, which is crucial for ensuring the continuity of drug supplies and reducing dependency on external sources.

Polpharma President Sebastian Szymanek emphasized: “Prometheus is not just a modern facility, but above all a comprehensive solution for the production of highly active pharmaceutical ingredients (HP API). These substances are crucial, particularly in the field of oncology, where, as we all know, the incidence of cancer is unfortunately increasing at an alarming rate. Our investment will enable a more effective fight against this challenge by providing essential tools for modern medicine. Our enthusiasm and pride stem from the belief that thanks to Prometheus, Polpharma will be able to contribute even more effectively to improving the health and quality of life of patients not only in Poland but throughout Europe. This is how we fulfill our mission: Helping people live healthy in a healthy world.”

Marshal of the Pomeranian Voivodeship, Mieczysław Struk, added: “No operation can take place without drugs, and in the overwhelming majority of cases, doctors are completely helpless without the use of medications. However, before a drug reaches the pharmacy or hospital, it must be developed by scientists and then produced in specialized factories. This requires close cooperation between manufacturers, the government, regulatory bodies, pharmacists, doctors, and patients to ensure that drugs are safe, effective, available, and properly used. Nevertheless, in the age of global threats, drug security, especially in terms of availability, supply continuity, and strategic drug reserves, becomes a vital issue for the functioning of public health protection.”

Development of production capacities

The opening of the center is just the beginning. Further development in the field of production and research of highly active substances is anticipated. Plans include doubling production capacity with a second small-scale production line and the construction of a new production hall for the production of highly active substances in much larger quantities, as well as a quality control laboratory tailored to the requirements of working with such substances.

Thanks to Polpharma’s new center, it becomes possible to seek innovative solutions, develop the Polish pharmaceutical industry, and contribute to building Poland’s drug security.

 

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