Active Pharmaceutical Ingredients (APIs) e phetha karolo ea bohlokoa indastering ea meriana 'me ke motheo o ka sehloohong oa tlhahiso ea meriana eohle.
Boholo ba 'maraka ba indasteri ea meriana ea Japane bo boemong ba bobeli Asia.Ka keketseho ea litšenyehelo tsa R & D tsa indasteri ea meriana le mabaka a mang, ho lebeletsoe hore 'maraka oa Japane APIs o tla hōla ka tekanyo e batlang e le holimo ho 7% ho ea ho 8% ka 2025. Har'a bona, lik'hamphani tsa meriana tse kileng tsa phetha karolo ea bohlokoa li kenyelletsa. Sun Pharmaceutical, Teva, Novartis International AG, Piramal Enterprises, le Aurobindo.
Ntlafatso ea indasteri ea litlhare tse tloaelehileng ea Japane e boetse e tobane le tšitiso ea phepelo e sa lekaneng e ikemetseng ea thepa e tala.Hoo e ka bang 50% ea thepa ea eona ea malapeng ea li-API e sebelisetsoa tlhahiso ea lithethefatsi tse tloaelehileng, 'me barekisi ba ka sehloohong ba machaba ba tsoa linaheng tsa Asia le Europe tse kang India, China, South Korea, Italy, Spain, Hungary le Jeremane.E le ho fokotsa ho itšetleha ka li-API tse tsoang linaheng tse ling, Japane e tsepamisitse maikutlo tabeng ea ho kenya li-API.
Sumitomo Pharmaceuticals, k'hamphani ea pele ea Japane ho hlahisa meriana ea lik'hemik'hale e sebelisa theknoloji e tsoetseng pele ea organic synthesis, e rera ho haha mochine o mocha oa li-API tsa lithethefatsi tsa molek'hule le fektheri e bohareng ea Oita City, Oita Prefecture.Sepheo se seholo sa morero ke ho eketsa bokhoni ba tlhahiso ea API ea k'hamphani ho finyella tlhokahalo e ntseng e eketseha ea li-API le li-intermediate tsa boleng bo phahameng.
Semela se secha se reretsoe ho qala ho sebetsa ka September 2024. Lefapha la eona la nts'etsopele ea konteraka le tlhahiso (CDMO) le sebelisa theknoloji e ikhethang ho hlahisa le ho fana ka li-API tse nyenyane tsa molek'hule le li-intermediate bakeng sa lik'hamphani tsa tlhahiso, le ho hlokomela thekiso ea khoebo ea ka ntle.Ka lebaka la tlhokahalo e matla ea merero e mecha ea ntlafatso ea lithethefatsi, 'maraka oa lefats'e oa meriana oa CDMO o bolokile kholo e tsoelang pele.Ho hakanngoa hore boleng ba hona joale ba khoebo ea lefats'e ea meriana ea CDMO e ka bang lidolara tse limilione tse likete tse 81 tsa US, tse lekanang le 10 trillion yen.
E itšetlehile ka mokhoa oa eona o babatsehang oa tiiso ea boleng le melemo ea tsamaiso ea lefats'e ea phepelo ea thepa, Sumitomo Pharmaceuticals e ekelitse khoebo ea eona ea CDMO butle-butle ho theosa le lilemo 'me e thehile boemo bo ka sehloohong Japane.Limela tsa eona tsa Gifu le Okayama li na le matla a fokolang a tlhahiso.Matla a matla a tlhahiso ea li-API le li-intermediate tse hlokahalang bakeng sa lithethefatsi tsa phekolo ea limolek'hule.Moetsi oa konteraka ea meriana oa Japane Bushu Corporation e fihletse tumellano ea tšebelisano le Suzuken Pharmaceutical Company ka Mmesa 2021 ho fana ka tšehetso e ncha ea nts'etsopele ea sehlahisoa bakeng sa lik'hamphani tsa litsebi tsa meriana tse ikemiselitseng ho kena 'marakeng oa Japane.Bushu o na le tšepo ea ho phethahatsa tumellano ea tšebelisano-'moho bakeng sa tlhahiso e tobileng ea malapeng ea li-API, ka tšebelisano-'moho ea lik'hamphani tse peli tsa meriana, ho fana ka lits'ebeletso tsa tsamaiso e le 'ngoe bakeng sa tlhokahalo ea lithethefatsi tse khethehileng, ho kenyelletsa le ho khothaletsa lipuisano tsa ba nang le tumello / ba nang le lithethefatsi, ho kenya thepa, tlhahlobo ea 'maraka, Tlhahiso le phepelo, polokelo le lipalangoang tse tšepetsoeng, tlhahlobo ea ntlafatso le thuso ea mokuli le lits'ebeletso tse ling.
Ka nako e ts'oanang, Bushu Pharmaceuticals e ka isa lithethefatsi ho bakuli ka mokhoa o sireletsehileng nakong eohle ea ts'ebetso ka ho sebelisa mokhoa o khethehileng oa ho lekola li-cold chain chain (Cubixx) o ntlafalitsoeng ke Suzuken Co., Ltd. Ho feta moo, Astellas Pharmaceutical Company ea Japane e senotse hore ho latela morero oa boraro oa katoloso ea tlhahiso, motheo oa API bakeng sa tlhahiso ea lithethefatsi tse sa fetoheng tse thehiloeng Toyama, Japane ka Pherekhong 2020 e tla sebelisoa ho etsa tacrolimus hydrate API ea mantlha ea Astellas Prograf.
Tacrolimus ke setlhare se thibelang le ho alafa ho lahloa ha litho tsa batho ba baholo le bana ba amohetseng sebete, liphio, pelo (le tumello e ncha ea FDA ka 2021).
Nako ea poso: Jun-03-2019
