1.近期,FDA批准齐鲁制药集团齐鲁天和惠世公司生产的注射用哌拉西林钠他唑巴坦钠(邦达)的上市申请。


我国制剂国际化2018年Q1,对美出口过9000万美元


其中一个规格如下:


Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 
Proprietary Name: PIPERACILLIN AND TAZOBACTAM 
Dosage Form; Route of Administration: INJECTABLE; INJECTION 
Strength: EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL 
Reference Listed Drug: No 
Reference Standard: No 
TE Code: AP 
Application Number: A204959 
Product Number: 001 
Approval Date: Aug 10, 2018 
Applicant Holder Full Name: QILU TIANHE PHARMACEUTICAL CO LTD 
Marketing Status:  Prescription 


2.齐鲁制药其他的ANDA:


Proprietary  Name Appl No
CEFAZOLIN SODIUM A203661
CEFEPIME HYDROCHLORIDE A203704
CEFEPIME HYDROCHLORIDE A203704
CEFEPIME HYDROCHLORIDE A203704
CEFTRIAXONE A203702
CEFTRIAXONE A203702
CEFTRIAXONE A203702
CEFTRIAXONE A203702
IRINOTECAN HYDROCHLORIDE A203380
IRINOTECAN HYDROCHLORIDE A203380
IRINOTECAN HYDROCHLORIDE A203380
OLANZAPINE A204319
OLANZAPINE A204319
OLANZAPINE A204319
OLANZAPINE A204319
OLANZAPINE A204319
OLANZAPINE A204319
ONDANSETRON HYDROCHLORIDE A203711
OXALIPLATIN A204616
OXALIPLATIN A204368
OXALIPLATIN A204616
OXALIPLATIN A204368
OXALIPLATIN A204368
PIPERACILLIN AND TAZOBACTAM A204959
PIPERACILLIN AND TAZOBACTAM A204959
PIPERACILLIN AND TAZOBACTAM A204959
TENOFOVIR DISOPROXIL FUMARATE A209498
TENOFOVIR DISOPROXIL FUMARATE A209498
TENOFOVIR DISOPROXIL FUMARATE A209498

更多齐鲁制药信息,点击:

一文初识齐鲁制药


3.据中国医药保健品进出口商会:2018年一季度,中国对美国化药制剂出口额超过9000万美元,同比增长18.8%。恒瑞医药、华海药业、南通联亚、人福医药、齐鲁制药等5家位居出口前列,占制剂总出口额的67%。


我国制剂国际化2018年Q1,对美出口过9000万美元



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