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Certificate of GMP Compliance

Confirming Good Manufacturing Practice (GMP) compliance for alfacalcidol, calcifediol monohydrate, calcipotriol anhydrous, calcitriol, tacalcitol monohydrate, imatinib, latanoprost and anastrozol
Issued by Main Pharmaceutical Inspector (GIF)
Certificate No. GIF-IW-N-4022/162/09
Certificate of GMP Compliance

GMP Certificate

Certificate of GMP Compliance

Confirming Good Manufacturing Practice (GMP) compliance for carvedilol, olanzapine, (+)-clopidogrel bisulfate and nitrendipine
Issued by Main Pharmaceutical Inspector (GIF)
Certificate No. GIF-IW-N-4022/115/10
Certificate of GMP Compliance

GMP Certificate

Certificate of GMP Compliance

Confirming Good Manufacturing Practice (GMP) compliance for sterile products (lyophilisates) and non-sterile products (capsules, soft shell)
Issued by Main Pharmaceutical Inspector (GIF)
Certificate No. GIF-IW-N-4022/15/09
Certificate of GMP Compliance

GMP Certificate

Statement of GLP Compliance

Confirming Good Laboratory Practice (GLP) compliance of pharmacokinetic studies, e.g. bioavailability and bioequivalence
Issued by Bureau for Chemical Substances and Preparations
Certificate No. 2/2010/GLP
Statement of GLP Compliance

GLP Certificate

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 01
Alfacalcidol - EDQM Certificate of Suitability

Alfacalcidol

Certificate of Suitability

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 01
Calcitriol - EDQM Certificate of Suitability

Calcitriol

GIF´s Permission

Permission for manufacturing of medicinal products
Issued by Main Pharmaceutical Inspector (GIF)
Certificate No. GIF-IW-N-4001/WTC079/330/11
GIF´s Permission [in Polish]

GIF´s Permission

Accreditation in Japan

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

Accreditation in Japan