Certificates
We invite you to cooperate with us in the comprehensive development and implementation of medicinal product manufacturing technologies:
– development of active substance synthesis
– active substance manufacturing
– development of drug form manufacturing technology
– analytical testing; marketing authorisation.
Research and development documentation is prepared in accordance with applicable GMP and GLP requirements. We offer a wide range of APIs (active pharmaceutical ingredients) manufactured under certified GMP conditions and holding GIF certificates.
Oferujemy również usługi Sekcji Analityki Chemicznej (Laboratorium Analityki Farmaceutycznej), posiadającej Certyfikat Systemu Zarządzania zgodny z normą ISO 9001.
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
Management System Certificate compliant with ISO 9001
Analizy chemiczne i badania analityczne.
Dla: Laboratorium Analityki Farmaceutycznej, Sekcja Analizy Chemicznej
Publisher: DNV
Certificate number: 253644-2018-AQ-POL-RvA
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