I-KornnacCaps Iqeda Ngempumelelo Ukubhaliswa Kwe-EU, Amaphilisi eGelatin Agunyazwe Ukuthunyelwa Emakethe YaseYurophu

May 12, 2026

Shiya umlayezo

Inkampani Hubei Kornnac Pharmaceutical Co., Ltd. (KornnacCapsngamafuphi, ngaphambilini eyake yaba yi-Hubei Humanwell Pharmaceutical Excipients Co., Ltd.,) ifinyelele enye ingqopha-mlando ohambweni lwayo lokuhwebelana kwembulunga yonke futhi inkampani isiqedele ngokusemthethweni ukubhaliswa kwayo kabusha-emakethe ye-EU futhi yagunyazwa ngempumelelo, yathola inombolo yomkhondo 4700/20001. Lokhu kuphawula ukuthi imikhiqizo ye-gelatin capsule ye-KornnacCaps ihlangabezane ngokugcwele nezindinganiso zokufinyelela eziqinile ze-EU futhi igunyazwe ngokusemthethweni ukuze lithunyelwe emakethe yaseYurophu, okwenza isisekelo esiqinile sokuthi inkampani iqhubeke nokwandisa umkhondo wayo wamazwe ngamazwe.

 

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Impumelelo yalokhu kubhaliswa kwe-EU isukela ekuhlelweni kwamasu okulandela ukushintshwa kwegama lenkampani. Ngemva kokushintsha igama layo ngokusemthethweni lisuka ku-Hubei Humanwell Pharmaceutical Excipients Co., Ltd. kuya ku-Hubei Kornnac Pharmaceutical Co., Ltd., inkampani ngokushesha yaqala{5}}inqubo yokubhalisa kabusha yemakethe ye-EU ukuze iqinisekise ukuqhubeka okungenazihibe nokusebenza ngokuthobelana ebhizinisini layo lamazwe ngamazwe. Ngokubhekana nohlaka lokulawula oluqinile lwe-EU kanye nezinqubo eziyinkimbinkimbi zesimemezelo, ithimba le-KornnacCaps lisukume lafinyelela inselele. Ngokusebenzisa iminyaka engaphezu kwengu-20 yokuhlangenwe nakho okujulile kokukhiqiza kumaphilisi angenalutho kanye nohlelo lokuphatha ikhwalithi olukhethekile, ithimba lalungiselela futhi labuyekeza yonke imibhalo edingekayo, ekugcineni laphasisa ukubhaliswa ngokushelela futhi lathola iPasi yokungena emakethe yaseYurophu.

 

Kubaluleke kakhulu ukuqaphela ukuthi, ngokwemithetho efanelekile ye-EU, ukuthumela imikhiqizo ye-gelatin capsule ku-EU akudingi nje ukubhaliswa okuyisisekelo kwe-EU kodwa futhi nokutholwa kwesitifiketi Sodokotela Wezilwane. Lokhu kungenxa yokuthi izinto zokusetshenziswa ze-gelatin ngokuvamile-zivela ezilwaneni, futhi i-EU ibeka izimfuneko eziphezulu kakhulu ze-biosafety kuzo. I-KornnacCaps isebenzisa ukulawula okuqinile kulo lonke uchungechunge lokunikezwa kwezinto kusukela ekulandelekeni kwezinto ezingavuthiwe nokulawulwa kwekhwalithi yokukhiqiza kuya endaweni yokugcina impahla kanye nokuhlelwa kwezinto, iqinisekisa ukuthi imikhiqizo yayo ithobelana ngokugcwele nezindinganiso ze-EU zokuhlanzeka nokuphepha kwemikhiqizo{3}}yezilwane. Ukuthola ngempumelelo Isitifiketi Sodokotela Wezilwane kuye kwasusa isithiyo sokugcina sokuthekelisa ngaphandle kwamaphilisi amaphilisi egelatin ngaphandle kwezinkinga.

 

Ukuthola iUkubhaliswa kwe-EU kanye nenombolo yomkhondo 4700/20001akukhona nje kuphela ukuqashelwa okuphezulu kwekhwalithi yomkhiqizo we-KornnacCaps namandla okuthobela kodwa futhi kuwumphumelelo obalulekile wesu lenkampani lokuhwebelana kwembulunga yonke. Ukuqhubekela phambili, i-KornnacCaps izoqhubeka nokusekela ifilosofi ye-Quality First, Ukuthobelana Okuphambili, ukuzibandakanya ngokujulile ku-R&D kanye nokukhiqizwa kwamaphilisi e-gelatin, amaphilisi emifino, nochungechunge lwe-capsule olukhethekile. Ngemikhiqizo namasevisi{2}ekhwalithi ephezulu nakakhulu, sizonika amandla izimboni zomhlaba jikelele zemithi nempilo, sibonise ubukhona obuvelele bokukhiqiza okuhlakaniphile kwaseShayina ezingeni lamazwe ngamazwe!

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