Overview

Pharmaceutical Products

Purolite has been manufacturing and selling to the generic pharmaceutical market for over three decades. Our resins are used in drug formulations as active pharmaceutical ingredients (APIs) or excipients. The production of all pharmaceutical products must adhere to strict guidelines. Purolite pharmaceutical resins meet the demands of the American (USP), European (Ph.Eur.), British (BP) and Japanese (JP) pharmacopeias. Drug Master Files (DMFs) are held for each, single, listed API pharmaceutical product manufactured in Purolite’s facilities. We provide support to allow rapid filing and approval by the FDA.

In addition to their application as active pharmaceutical ingredients and excipients, ion exchange resins and polymeric adsorbents can be used in a wide variety of pharmaceutical applications including extraction and purification of enzymes, hormones, alkaloids, viruses, antibiotics, and treatment of fermentation products. Ion exchange copolymer beads are also used in nanoparticle milling of pharmaceutical products.

Regardless of application, Purolite has redundant production operations around the world to ensure the security of supply necessary to participate in the pharmaceutical production world.