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First CADIFA certification from ANVISA for Etodolac In the dynamic landscape of pharmaceutical regulations, Brazil took a significant stride in April 2020 when ANVISA unveiled new rules about active pharmaceutical ingredients (APIs). Fast forward to August 2020, and these regulations officially became effective in Brazil’s vibrant pharmaceutical market. As we approach August 2023, a pivotal…

KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021. The new facility is adapted to GMP conditions and allows work with products with OEL>200 ng/m3(so-called High Potent API – OEB category 5).KiloLab has almost 120 m2 of production space and…

Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology and Zakłady Farmaceutyczne Polpharma S.A. have signed two agreements in the area of RVU120 active substance (Active Pharmaceutical Ingredient, API) production for Phase II clinical studies in hematology: RIVER-52 and RIVER-81. The…

Cold manufacturing Cryochemistry is the study of chemical interactions at temperatures below −150 °C (−238 °F; 123 K). It is derived from the Greek word cryos, meaning ‘cold’. But in traditional API manufacturing, cryochemistry refers to the temperatures of about -80°C. Cryogenic conditions facilitate precise chemical transformations that require very low temperatures. Reactions carried out under such conditions allow to: Running reactions…

On November 2022, at Polpharma API Plant, we implemented freeze-drying machine! Crunchy habits It has become a habit of the modern world to choose healthy rather than a junk food. Therefore, when we feel like having a popcorn, we often choose to crunch… a strawberry instead. However, can we actually enjoy all natural and healthy…

In 2022, we are opening a new chapter in the history of Polpharma in the field of ​​active substances. With the strategic investment in a HPAPI facility, Polpharma and Poland are becoming a strong pillar of the European pharmaceutical industry in the coming decades. Grand opening of new R&D & Production Facility in Q1 2024…

N-nitrosamine impurities have been in the news for some years now. Karina Boszko, head of API Regulatory Affairs and Customer Technical Support Department, explains how we at Polpharma undertake this challenge. What are nitrosamines, and how do they affect human health?  In July 2018, the pharmaceutical industry was shaken when nitrosamine impurities were detected in…

Polpharma has established cooperation with Pikralida, a biopharmaceutical start-up that is working on a breakthrough therapeutic solution to protect against the development of epilepsy after a traumatic brain injury or stroke. The cooperation involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of…

This process targets clear information flow from an efficiency perspective based on KPIs, facilitating rapid and correct decisions….

People and their ability to change are the key drivers of each transformation.