Accelerate your biologic drug development with Praesto®
Our safe and reliable products meet and surpass the benchmarks for product quality.
Nos équipes de support technique et de service toujours prêtes font un pas supplémentaire pour devenir votre ressource la plus fiable. Nous sommes là pour vous.
Food and Drug Administration & EC ResAP (2004)3
The Purolite Romanian manufacturing facility is US-FDA inspected for the production and distribution of APIs. Products used in food and beverage consumption comply with ResAP (2004)3 and/or FDA 173.25 and 173.65 regulations.
Establishment Inspection Report
Establishment Registration Renewal Certificate
Current Good Manufacturing Practice Certificate
Resolution ResAP (2004)3
FDA 173.25 Ion Exchange Resins
FDA 173.65 Adsorbents
FDA Status for Chromalite Products Adsorbent Resins
FDA Status for Chromalite Products Strong Acid Cations
FDA Status for Chromalite Products Base Anion Resins
Japanese Pharmaceutical and Medical Devices Agency
The Japanese authority, Pharmaceutical and Medical Devices Agency (PMDA), is equivalent to the FDA in the United States of America. PMDA issues certificates of accreditation of API manufacturers (GMP compliance).
Certificate of Accreditation of API Manufacturers
French Health Ministry Approval
Download the French Health Ministry Certificates of Approval for Potable Water Treatment with Purolite products.
C100E Avis AFSSA
C100FMK9130 Avis AFSSA
Purolite A520E | PFA520E | PPA520E
Purolite C120E | PFC120E
Purolite produces Halal products under the supervision of several respected Islamic Councils. For the specific Halal certificate for each plant, please click on the links below.
China (IFANCA) | Romania | United States (IFANCA)
The Indonesian Council of Ulama, has also declared the China manufacturing plant to be Halal certified. Download the MUI certification for the China facility.
China (MUI Decree) | China (MUI Product List)
Purolite manufactures products in compliance with kosher production and packaging rules. Visit Kosher Certification and search Purolite for a complete list of our kosher-certified products.
Visit the Water Quality Association for a list of products that have been certified to NSF/ANSI 44 Standards and NSF/ANSI/CAN 61 Standards.
United Kingdom Secretary of State Approval
Visit the UK Drinking Water Inspectorate for a list of approved Purolite products for drinking water in the United Kingdom.
Water Regulations Advisory Scheme (WRAS) Approval8
The WRAS (Water Regulations Advisory Scheme) tests water products to ensure that they do not waste, misuse, unduly consume or contaminate the water supply. The following Purolite products have been aproved by WRAS in the United Kingdom:
All manufacturing and packaging equipment, raw materials and processing aids used in producing the below Purolite enzyme carriers comply with Annex IIIa of Directive 2000/13/EC, amended by Directive 2007/68/EC and are free from Transmissible Animal Spongiform Encephalopathy (TSE/BSE) or Genetically Modified Organisms(GMO) or Allergens.