Certificates & Licenses

  • Manufacturing authorisation
    Medicinal products manufacturing authorisation
    Issued by: Main Pharmaceutical Inspector (GIF)
    Certificate No.: GIF-IW-400/0079/01/651/56/16
    Manufacturing authorisation [in Polish]

  • Certificate of GMP Compliance
    Confirming Good Manufacturing Practice (GMP) compliance for Alfacalcidol, Calcifediol monohydrate,Calcipotriol anhydrous, Calcitriol, Paricalcitol, Brynzolamide
    Issued by: Main Pharmaceutical Inspector (GIF)
    Certificate No.: GIF-IW-400/0079_01_02/04/285/16
    Certificate of GMP Compilance

  • Certificate of GMP Compliance
    Confirming Good Manufacturing Practice (GMP) compliance for carvedilol, olanzapine, (+)-clopidogrel bisulfate and nitrendipin
    Issued by: Main Pharmaceutical Inspector (GIF)
    Certificate No.: GIF-IW-N-4022/223/13
    Certificate of GMP Compilance

  • Certificate of GMP Compliance
    Confirming Good Manufacturing Practice (GMP) compliance for human medicinal products.
    Issued by: Main Pharmaceutical Inspector (GIF)
    Certificate No.: GIF-IW-400/0079_01_01/04/145/14
    Certificate of GMP Compliance

  • Certificate of GMP Compliance
    Confirming Good Manufacturing Practice (GMP) compliance for veterinary medicinal products
    Issued by: Main Pharmaceutical Inspector (GIF)
    Certificate No.: GIF-IW-400/0079_01_01/04/146/14
    Certificate of GMP Compilance

  • Statement of GLP Compliance
    Confirming Good Laboratory Practice (GLP) compliance of pharmacokinetic and bioanalytical studies, e.g. bioavailability and bioequivalence
    Issued by: Bureau for Chemical Substances
    Certificate No.: 6/12016/DPL
    Statement of GLP Compliance

  • Certificate of Suitability
    Confirming suitability of alfacalcidol with the monograph of the European Pharmacopeia
    Issued by: European Directorate for the Quality of Medicines
    Certificate No.: R1-CEP 2000-399-Rev 02
    Alfacalcidol - EDQM Certificate of Suitability

  • Certificate of Suitability
    Confirming suitability of calcipotriol with the monograph of the European Pharmacopeia
    Issued by: European Directorate for the Quality of Medicines
    Certificate No.: R0-CEP 2011-158-Rev 00
    EDQM Certificate of Suitability

  • Certificate of Suitability (CEP)
    Confirming suitability of calcitriol with the monograph of the European Pharmacopeia
    Issued by: European Directorate for the Quality of Medicines
    Certificate No.: R1-CEP 2000-397-Rev 02
    Calcitriol - EDQM Certificate of Suitability

  • Accreditation in Japan
    Accreditation of foreign drug manufacturer
    Issued by: Ministry of Health, Labour and Welfare of Japan
    Certificate No.: AG22300003
    Accreditation in Japan