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.
Good Manufacturing Practice Certificate (GMP)
Confirming compliance of manufacturing conditions with GMP requirements for tested medicinal products intended for human use
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: ISF.405.93.2025.MP.5; WTC/0079_01_01/203
Good Manufacturing Practice Certificate (GMP)
Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: ISF.405.93.2025.MP.4; WTC/0079_01_01/202
Good Manufacturing Practice Certificate (GMP)
Confirming the quality of active substance manufacturing: Alfacalcidol, Calcifediol hydroxide, Tacalcitol hydroxide, Anastrozole, Latanoprost, Imatinib mesylate, Carvedilol, Cladribine, Sunitinib malate
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: IWSF.405.47.2023.IP.1.1; WTC/0079_01_02/90
Good Manufacturing Practice Certificate (GMP)
Confirming compliance of manufacturing conditions with GMP requirements for veterinary medicinal products
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: ISF.405.93.2025.MP.3; WTC/0034_01_01/201
Good Manufacturing Practice Certificate (GMP)
Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: ISF.405.93.2025.MP.2; WTC/0034_01_01/200
Good Manufacturing Practice Certificate (GMP)
Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use
Publisher: Chief Pharmaceutical Inspector (GIF)
Certificate No.: ISF.405.93.2025.MP.1; WTC/0034_01_01/199
Accreditation in Japan
Accreditation of foreign manufacturers of medicinal products
Publisher: Ministry of Health, Labour and Welfare, Japan
Certificate No.: AG22300014
CEP Certificate
Certificate of Conformity with the European Pharmacopoeia for the substance: Calcifediol Monohydrate
Certificate No.: R0-CEP 2022-335 – Rev 00
CEP Certificate
Certificate of Conformity with the European Pharmacopoeia for the substance: Alfacalcidol
Certificate No.: R1-CEP 2000-399 – Rev 05
CEP Certificate
Certificate of Conformity with the European Pharmacopoeia for the substance: Takalcitol Monohydrate
Certificate No.: R0-CEP 2019-220