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A ranar 12 ga Oktoba, 2024, JYMed's Liraglutide API ya sami takaddun Tabbacin Rubuce-rubuce (WC), wanda ke nuna muhimmin mataki ga nasarar fitar da API zuwa kasuwar EU.

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TheWC (Tabbatar Rubutun)bukatu ne na wajibi don fitar da APIs daga ƙasashen da ba na EU ba zuwa kasuwar EU. An bayar da ita ta hanyar hukuma mai kula da ƙasar da ake fitarwa, wannan takardar shaidar tana tabbatar da cewa API ɗin da aka fitar ya bi ka'idodinKyakkyawar Ƙarfafa Ƙarfafa (GMP)matakan da EU ta kafa. Yana taka muhimmiyar rawa wajen tabbatar da inganci da amincin APIs kuma yana da mahimmanci ga ƙasashen da ba EU ba da ke neman damar shiga kasuwar magunguna ta EU.

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Karɓar takaddun shaida na WC don Liraglutide API ba wai kawai yana nuna amincewar hukuma na inganci da amincin samfuran JYMed ba amma yana haɓaka ikon kamfanin don faɗaɗa kasancewar sa a cikin kasuwar API ta EU. Wannan nasarar tana ƙarfafa matsayin JYMed a cikin masana'antar harhada magunguna ta duniya, tana ba da damar ci gaba mai girma da kuma ƙara suna a duniya.

Game da JYMed

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Shenzhen JYMed Technology Co., Ltd. (nan gaba ake magana a kai a matsayin JYMed) an kafa a 2009, ƙware a cikin bincike, ci gaba, samarwa, da kuma tallace-tallace na peptides da peptide alaka kayayyakin. Tare da cibiyar bincike guda ɗaya da manyan sansanonin samarwa guda uku, JYMed yana ɗaya daga cikin manyan masu samar da peptide API ɗin da aka haɗa ta sinadarai a cikin Sin. Babban ƙungiyar R&D na kamfanin yana alfahari sama da shekaru 20 na gogewa a cikin masana'antar peptide kuma ta sami nasarar wuce binciken FDA sau biyu. JYMed ta m da ingantaccen tsarin masana'antu peptide masana'antu yayi abokan ciniki cikakken kewayon ayyuka, ciki har da ci gaba da kuma samar da warkewa peptides, dabbobi peptides, antimicrobial peptides, da kwaskwarima peptides, kazalika da rajista da kuma kayyade goyon baya.

Babban Ayyukan Kasuwanci

1.Domestic da na duniya rajista na peptide APIs

2.Veterinary da na kwaskwarima peptides

3.Custom peptides da CRO, CMO, OEM ayyuka

4.PDC kwayoyi (peptide-radionuclide, peptide-kananan kwayoyin halitta, peptide-protein, peptide-RNA)

Baya ga Tirzepatide, JYMed ya ƙaddamar da takaddun rajista tare da FDA da CDE don wasu samfuran API da yawa, gami da shahararrun magungunan ajin GLP-1RA a halin yanzu kamar Semaglutide da Liraglutide. Abokan ciniki na gaba masu amfani da samfuran JYMed za su iya yin la'akari kai tsaye lambar rajistar CDE ko lambar fayil ɗin DMF lokacin ƙaddamar da aikace-aikacen rajista ga FDA ko CDE. Wannan zai rage mahimmancin lokacin da ake buƙata don shirya takaddun aikace-aikacen, da kuma lokacin kimantawa da farashin bitar samfur.

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Tuntube Mu

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Shenzhen JYMed Technology Co., Ltd.

Adireshin: bene na 8 & 9, Ginin 1, Shenzhen Biomedical Innovation Industrial Park, No. 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Waya: +86 755-26612112
Yanar Gizo:http://www.jymedtech.com/


Lokacin aikawa: Oktoba-17-2024
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