Tsis ntev los no, Sinopharm Group Industry Co., Ltd. (tom qab no hu ua "Sinopharm Kev Lag Luam"), ib qho tag nrho - tus tswv lag luam ntawm Shanghai Modern Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab"), tau txais "Daim Ntawv Pom Zoo rau Kev Tso Cai Ua Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj (Tshuaj Ingred)API)" tau tshaj tawm thiab pom zoo los ntawm National Medical Products Administration (NMPA) ntawm Cov Neeg Tuam Txhab Tuam Txhab Tuam Txhab Tuam Tshoj, uas pom zoo rau daim ntawv tso cai ua lag luam rau API Nalbuphine Hydrochloride. Cov ntaub ntawv cuam tshuam tau tshaj tawm raws li hauv qab no:
I. Cov ntaub ntawv tseem ceeb ntawm Chemical API
Lub npe ntawm Chemical APITom ntej: Nalbuphine Hydrochloride
Tus lej sau npe: Y20230000775
Daim Ntawv Ceeb Toom: 2024YS01375
Kev Sau Npe Tus Qauv Zauv ntawm Chemical APIPIB: YBY76782024
Ntim SpecificationsNtim: 1kg / hnab, 2kg / hnab
Chaw tsim tshuaj paus: Langfang ceg ntawm Sinopharm Group Industry Co., Ltd.
Chaw Nyob: Chuangye Road, Langfang Economic thiab Technological Development Zone
Cov khoom siv: Daim ntawv thov kev tso cai ua lag luam rau kev tsim cov tshuaj API hauv tsev
Kev pom zoo xaus: Raws li "Drug Administration Law of the People's Republic of China" thiab cov kev cai cuam tshuam, tom qab kev tshuaj xyuas, cov khoom no ua tau raws li cov kev cai tsim nyog rau kev sau npe tshuaj thiab raug pom zoo rau kev sau npe.
II. Tshuaj R&D thiab Market Status
Nalbuphine Hydrochloride yog ib qho κ-opioid receptor agonist thiab μ-opioid receptor antagonist, ua raws li lub hauv paus muaj zog analgesic. Nws cov khoom lag luam muaj feem xyuam nrog, Nalbuphine Hydrochloride Txhaj, feem ntau yog siv los ua ib qho tshuaj adjuvant rau induction ntawm tshuaj loog thaum lub sij hawm ua ke tshuaj loog, thiab kuj rau relieving mob nruab nrab mus rau hnyav.
Raws li lub vev xaib ntawm Lub Chaw Tshawb Fawb Tshuaj (CDE), lwm lub tuam txhab hauv tebchaws nrog rau npe "A" rau Nalbuphine Hydrochloride API tam sim no suav nrog Yichang Humanwell Pharmaceutical Co., Ltd., Jiangsu Haici Biopharmaceutical Co., Ltd. ntawm Yangzijiang Pharmaceutical Group, thiab lwm yam Cov ntaub ntawv los ntawm Pharmaceutical Database Build. (PDB) qhia tias lub ntiaj teb kev noj Nalbuphine API hauv 2023 yog 762.49kg.
