As a significant European API producer with cGMP-compliant and FDA-approved multipurpose facilities, we are present in 60+ countries in 6 continents. Regular and successful FDA audits enabled us to register and sell a number of APIs in the US market thus confirming our reliability and credibility towards all Polpharma business partnerships around the world.
In addition to “ready to use” API products, Polpharma B2B offers custom-made synthesis service for clients looking for a European manufacturing site for their active substances. Polpharma B2B offers full support from process optimization, analytical method development & validation, to process scale-up to pilot plant (kg scale) and fully commercial, multi-tons synthesis in EU cGMP, FDA (US), Anvisa (Brazil), PMDA (Japan) & KFDA (Korea) approved facility. The scope of our services includes also preparation of comprehensive regulatory documentation in an eCTD format (ASMF, CEP, US DMF, Japanese DMF, Chinese DMF). The entire process is led by professional project management team coordinating for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma - all of this with the sole purpose of you maintaining a full control over your product.