He mea nui ka Active Pharmaceutical Ingredients (APIs) i ka ʻoihana lāʻau lapaʻau a ʻo ia ke kumu mua no ka hana ʻana i nā lāʻau lapaʻau āpau.
ʻO ka nui o ka mākeke o ka ʻoihana lāʻau lapaʻau Iapana ka lua ma Asia.Me ka piʻi ʻana o nā lilo R&D o ka ʻoihana lāʻau lapaʻau a me nā kumu ʻē aʻe, ua manaʻo ʻia e ulu ka mākeke Japanese API ma kahi kiʻekiʻe kiʻekiʻe o 7% a 8% e 2025. ʻO Sun Pharmaceutical, Teva, Novartis International AG, Piramal Enterprises, a me Aurobindo.
Ke kū nei ka hoʻomohala ʻana o ka ʻoihana lāʻau lapaʻau maʻamau o Iapana i ke keʻakeʻa o ka lawa ʻole o ka lako kūʻokoʻa o nā lako maka.Ma kahi kokoke i 50% o kāna mau hoʻokomo ʻana i nā API i hoʻohana ʻia no ka hana ʻana i nā lāʻau lapaʻau maʻamau, a ʻo nā mea hoʻolako honua nui mai nā ʻāina ʻo ʻAsia a me ʻEulopa e like me India, Kina, South Korea, Italia, Sepania, Hungary a me Kelemānia.I mea e hōʻemi ai i ka hilinaʻi ʻana i nā API i lawe ʻia mai, ke kālele nei ʻo Iapana i ka localization o nā API.
ʻO Sumitomo Pharmaceuticals, ka hui mua ma Iapana e hana i nā lāʻau kemika me ka hoʻohana ʻana i ka ʻenehana synthesis organik holomua, e hoʻolālā e kūkulu i kahi API lāʻau liʻiliʻi liʻiliʻi hou a me nā hale hana waena ma Oita City, Oita Prefecture.ʻO ka pahuhopu nui o ka papahana ʻo ia ka hoʻonui ʻana i ka hiki o ka hana API o ka hui e hoʻokō i ka koi ulu ʻana no nā API kiʻekiʻe a me nā mea waena.
Ka mea kanu hou ua hoʻonohonoho 'ia e hookomo i loko o ka mahinaʻai ma Sepatemaba 2024. Kona 'aelike hoʻomohala a me ka hana (CDMO) oihana hoʻohana 'ike loea kūikawā e hana a hoʻolako liʻiliʻi mole API a me nā intermediates no ka formulation hui, a hoʻomaopopo i waho kalepa kuai.Ma muli o ka koi ikaika no nā papahana hoʻomohala lāʻau hou, ua hoʻomau ka mākeke CDMO lāʻau lapaʻau honua i ka ulu mau.Ua manaʻo ʻia ʻo ke kumukūʻai pāʻoihana honua o ka lāʻau CDMO ma kahi o 81 biliona kālā ʻAmelika, e like me 10 trillion yen.
Ke hilinaʻi nei i kāna ʻōnaehana hōʻoia maikaʻi maikaʻi a me nā pono hoʻokele waiwai hoʻolako honua, ua hoʻonui mālie ʻo Sumitomo Pharmaceuticals i kāna ʻoihana CDMO i nā makahiki a ua hoʻokumu i kahi kūlana alakaʻi ma Iapana.ʻO kāna mau mea kanu ma Gifu a me Okayama he liʻiliʻi ka mana hana.ʻO ka mana hana ikaika o nā API a me nā mea waena e pono ai no nā lāʻau lapaʻau molecular.Ua hōʻea ʻo Bushu Corporation i kahi ʻaelike hui me ka Suzuken Pharmaceutical Company i ʻApelila 2021 e hāʻawi i ke kākoʻo hoʻomohala huahana hou no nā ʻoihana lāʻau lapaʻau e manaʻo nei e komo i ka mākeke Iapana.Manaʻo ʻo Bushu e hoʻokō i kahi kuʻikahi hui no ka hana ʻana i ka home o nā API, ma o ka hui pū ʻana o nā hui lāʻau lapaʻau ʻelua, e hāʻawi i nā lawelawe hoʻokele hoʻokahi no ka noi ʻana i nā lāʻau lapaʻau kūikawā, me ka hoʻolaha ʻana o nā mea paʻa ʻae / nā mea paʻa lāʻau hoʻololi kūkākūkā. ka lawe ʻana mai, ka loiloi mākeke, Ka hana a me ka hoʻolako ʻana, ka mālama ʻana a me ka halihali ʻana, ka loiloi hoʻolaha a me ke kōkua maʻi a me nā lawelawe ʻē aʻe.
I ka manawa like, hiki i ka Bushu Pharmaceuticals ke hāʻawi i nā lāʻau lapaʻau i nā maʻi ma ke kaʻina holoʻokoʻa ma o ka hoʻohana ʻana i ka ʻōnaehana ʻōnaehana micro-cold chain monitoring kūikawā (Cubixx) i hoʻomohala ʻia e Suzuken Co., Ltd. ʻO ke kolu o ka hoʻolālā hoʻonui ʻana, ʻo ka waihona API no ka hana ʻana i nā lāʻau lapaʻau paʻa i hoʻokumu ʻia ma Toyama, Iapana i Ianuali 2020 e hoʻohana ʻia e hana i ka API tacrolimus hydrate API mua o Astellas Prograf.
He lāʻau lapaʻau ʻo Tacrolimus e pale a mālama i ka hōʻole ʻana o ke kino i nā maʻi maʻi makua a me nā keiki i loaʻa i ka ate, ka puʻuwai, ka puʻuwai (a me ka ʻāʻī hou o ka FDA i ka makahiki 2021).
Ka manawa hoʻouna: Jun-03-2019
