Department of Pharmaceutical Products
Product registration documentation
Products manufactured at the Institute have:
– GMP & CEP certificates
– accreditations (e.g. in Japan)
– ASMF documentation
We also offer support in preparing registration documentation and marketing authorisation.
Certificates
Good Manufacturing Practice Certificate (GMP)
Confirming the manufacturing quality of the active substances alfacalcidol, calcifediol hydrate, calcipotriol anhydrous, paricalcitol, brinzolamide
Publisher: General Pharmaceutical Inspector (GIF)
No cert.: IWSC.405.23.2019.ES.1-1/WTC/0079_01_02/133
Good Manufacturing Practice Certificate (GMP)
Confirming the manufacturing quality of the active substances carvedilol, (+)-clopidogrel bisulfatePublisher: General Pharmaceutical Inspector (GIF)No cert. GIF-IW-400/0079_01_02/04/86/17
Good Manufacturing Practice Certificate (GMP)
Confirming the quality of a medicinal product intended for human use.Publisher: General Pharmaceutical Inspector (GIF)No cert.: IWSC.405.102.2022.IP.2/WTC/0079_01_01/238
Good Laboratory Practice Certificate (GLP)
Confirming the quality of pharmacokinetic and bioanalytical studies, including equivalence and bioavailability studies
Issued by: Chemical Substances Office
Certificate No.: 25/2020/DPL
Accreditation in Japan
Accreditation of foreign manufacturer of medicinal productsPublisher: Ministry of Health, Labor and Welfare of JapanNo cert.: AG22300014
Good Manufacturing Practice Certificate (GMP)
Medicinal products for humansPublisher: Chief Pharmaceutical Inspector (GIF)No cert.: IWPS.405.102.2022.IP.1/ WTC/0079_01_01/237
Good Manufacturing Practice Certificate (GMP)
Veterinary medicinal products
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: IWPS.405.9.2020.AL.2 WTC/0034_01_01/149
Good Manufacturing Practice Certificate (GMP)
Tested medicinal products for humansPublisher: Chief Pharmaceutical Inspector (GIF)No cert.: IWPS.405.118.2022.OP.1/ WTC/0034_01_01/260