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 

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.

Vew Products

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.