Accelerate your biologic drug development with Praesto®
Our safe and reliable products meet and surpass the benchmarks for product quality.
Nuestros equipos de servicio y soporte técnico siempre listos dan un paso más para convertirse en su recurso más confiable. Estamos aquí por tí.
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
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)
United Kingdom Secretary of State Approval
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.
Regulatory expertise throughout the product life-cycle is essential to identify regulatory options for product development, optimize ‘speed to market’ and produce a product that meets customer needs.
View our Regulatory Information brochure for information on existing regulatory approvals.