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[GMP相关] GDUFA II facility paymen未付费企业情况(中国)

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药士
发表于 2017-11-15 11:29:44 | 显示全部楼层 |阅读模式

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本帖最后由 beiwei5du 于 2017-11-15 11:42 编辑

选自:https://www.pharmacompass.com/radio-compass-blog/one-in-six-facilities-fail-to-pay-fda-s-user-fees-is-the-us-generic-supply-chain-at-risk

A 17 percent drop in facilities that paid for the upcoming year

As the US generic business continues to face headwinds of increased competition, pricing pressure, channel consolidation and concerns over non-compliance, this week PharmaCompass reviewed a list posted on the FDA website which contains the GDUFA facility payments received by the agency.
The fees were due no later than October 1, 2017. A review more than one month later, as of payments listed on November 3, 2017, shows that as opposed to 1,436 facilities, which paid user fees last fiscal year, this year the number is down to 1,192, a reduction of almost 17 percent.
COUNTRY
API
API & FDF
FDF
TOTAL FACILITIES
United States
14
1
44
59
India
30
3
20
52
China
40
1
11
52
Germany
6
7
13
Italy
5
6
11
France
4
5
9
Japan
6
3
9
Canada
2
6
8
Spain
8
8
United Kingdom
2
3
5
Taiwan
1
5
5
Mexico
1
3
4


Was failure to comply with GMP a possible cause of non-payment?
Among those who did not pay the user fees were companies that have been in the news for failure to comply with good manufacturing practices (GMPs).
Aarti Drugs, Akorn, Dr Reddy’s, Wockhardt and Vital Laboratories in India and Chongqing Pharmaceutical Research Institute,Dongying Tianyong, Yunnan Hande Bio-Tech in China were some of the companies that have not paid the facility fee for a few or all of their facilities.






However, the number of companies that did not register because of a failure to comply with current GMP requirements is a small fraction of the 265-odd facilities that did not re-pay the necessary fees.
There were 21 new facilities which paid to join the US generic drug supply chain in FY2018. These new facilities, which manufacture APIs and fixed dosage forms (FDFs), are located in the United States, Europe, India and China.


Our view
Pharmaceutical manufacturing facilities don't get created overnight. It takes years for them to refine their practices and comply with the FDA's stringent compliance standards.
With more than 265 facilities not continuing to be part of the US generic supply chain, it is important to investigate whether the firms are simply delaying payments or is the business climate preventing companies from wanting to manufacture generic drugs for the US?
Since over 80 percent of all prescriptions filled in the United States are for generic drugs, if the US wants continued access to safe and affordable generic drugs, it will have to look into reasons behind companies falling out of the US generic supply chain. The answers to the question raised by us in the previous paragraph will be critical.
For, if the US doesn’t seek answers and looks for solutions, the generic supply chain of the world’s largest pharmaceutical market could surely be at risk.
以下为2017年付费,而2018年未付费的中国企业名单:

China
Agno Pharma Jiangsu
68 Dapu Road Lianyungang 222069 China
3009530424
API
China
Beijing Wanhui Double-Crane Pharmaceutical Co., Ltd.
No.1 Shangyuan Road Shilong Economic Development Zone Mentougou District Beijing China
3008771491
FDF
China
Beijing Yiling Bio-Engineering Technology Co.,Ltd
No. 23 Keji Road, Industrial Park, Miyun Beijing 101500 China
3009884007
FDF
China
Changzhou Ruiming Pharmaceutical Co., Ltd.
No.1558 Longjiang North Road Xinbei District Changzhou 213127 China
3007086821
API
China
CHANGZHOU SIYAO PHARMACEUTICALS CO LTD
Meilongba, Southern Suburbs Changzhou 213004 China
3003844102
API
China
China Resources Saike Pharmaceutical Co., Ltd.
No. 3 JingHai Seventh Street, Tongzhou District Beijing 101111 China
3002806597
FDF
China
CHINESE PEPTIDE COMPANY
No 69, 12th Street, Economic and Technological Develop Zone Hangzhou China
3004518843
API
China
Chongqing Kangle Pharmaceutical Co.,Ltd.
No. 4, Huazhong Road, Chongqing (Changshou) Chemical Industry Park Chongqing 401221 China
3007088564
API
China
Chongqing Pharmaceutical Research Institute Co., Ltd.
No 2 The Third Branch Road Huanan Road 401220 China
3011903543
API
China
Chongqing Pharmaceutical Research Institute Co., Ltd.
No. 565 Tushan Road Nanan District 400061 China
3001204127
API
China
CSPC Ouyi Pharmaceutical Co., Ltd.
No. 276, Zhongshan West Road Shijiazhuang 050051 China
3006040900
BOTH
China
CSPC Zhongnuo Pharmaceutical (Shijiazhuang)Co.,ltd.
No.91 Hainan Road,Economic& Development Zone Shijiazhuang 052160 China
3005684109
API
China
Dongying Tiandong Pharmaceutical Co.,Ltd
No.1236,Nan-er road, Dongying city, Shandong Province, China China
3004395180
API
China
Guang'an Kingday Pharma & Chem Co.,Ltd
Wusheng Industrial Park Guang'an 638400 China
3009846816
API
China
Haimen Pharma Inc.
No.163, Zhuhai Rd, Binjiang Street Haimen City 226100 China
3011266110
FDF
China
Hainan Hailing Chemipharma Corporation Limited
No. 281 Nanhai Avenue Haikou 570311 China
3006643956
FDF
China
Hangzhou Huadong Medicine Group Kangrun Pharmaceutical Co., Ltd.
24 Chengdong Road Anji County 313301 China
3008465758
API
China
Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
North Head of Yinchuang Street, Zhengding, Shijiazhuang 050800 China
3010849972
API
China
HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD., SHENZHOU PLANT
Xijingming Village, Donganzhuang Township, Shenzhou County Hengshui City, Hebei Province, 053800 CHINA China
3010285715
FDF
China
Hebei Yuxing Bio-engineering Co., Ltd.
Xicheng District, Ningjin Country, Hebei Province, CHINA 055550 China
3008996626
API
China
Hisun Pharmaceutical (Nantong) Co., Ltd.
No 18, 4th Haibin Road, Nantong 226407 China
3010956224
API
China
Huadong Medicine Co., Ltd.
No.700 Shixiang Road Hangzhou 310022 China
3007574798
API
China
Jiangsu Hansoh Pharmaceutical Group Co., Ltd (formerly Lianyungang Hongchuang Pharmaceutical Co., Ltd.)
Economic and Technical Development Zone Lianyungang 222047 China
3003663251
API
China
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
No. 5 Dongjin Road Lianyungang 222069 China
3008316144
FDF
China
Jiangsu Hansyn Pharmaceutical Co. Ltd
No. 528, East Changjiang Road, Zhangjiagang 215635 China
3011422497
API
China
Jiangsu Hengrui Medicine Co., Ltd.
Dongjin Road, Port Industry Area Lianyungang 222069 China
3003404148
FDF
China
Lianyungang Kangle Pharmaceutical Co., Ltd
No.2 Huanan Road, Ganyu Economic Development Zone Lianyungang 222100 China
3010728729
API
China
Linhai Tianyu Pharmaceutical Co., Ltd.
No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone taizhou 317016 China
3013345425
API
China
Nantong Jinghua Pharmaceutical Co., Ltd.
No. 20, 3 Haibin Road, Yanhai Economic Development Zone Rudong, Nantong 226407 China
3003735909
API
China
Ningbo Renjian Pharmaceutical Group Co., Ltd.
555 Changchi Road, Cixi Ningbo 315300 China
3004160744
API
China
No.1 Branch Plant of Southwest Synthetic Pharmaceutical Corp., Ltd.
Luoqi, Yubei District Chongqing China
3003723024
API
China
No.2 Branch Plant of Southwest Synthetic Pharmaceutical Corp., Ltd.
Cuntan, Jiangbei District Chongqing China
3003094545
API
China
North China Pharmaceutical Huasheng Co. Ltd
Shijiazhuang Economic & Technological Development Zone Shijiazhuang 052160 China
3003001488
API
China
Porton Pharmaceutical Ltd.
82-1 Kecheng Road, Erlang, Jiulongpo District Chongqing 400039 China
3006305268
API
China
Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.
North of Huayuan Road (W), Linyi County Dezhou 251500 China
3003877289
API
China
Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
No 10, Longhai Road, Qinhuangdao 066004 China
3009653722
API
China
Second Pharma Co Ltd
No.33 Weiwu Road Shangyu 312369 China
3004836637
API
China
Shanghai Ajinomoto Amino Acid Co., Ltd.
718 Rongle (E) Rd. Song 201613 China
3004567034
API
China
Shanghai Desano Bio-Pharmaceutical Co., Ltd.
1479 Zhangheng Road Zhangjiang Hi-Tech Park 201203 China
3008345655
FDF
China
Shanghai Wonder Pharmaceutical Co., Ltd.
No. 2068 Jinzhang Highway, Jinshan District Shanghai 201518 China
3004547326
API
China
Shenzhen Techdow Pharmaceutical Co., Ltd
No.19 Gaoxinzhongyi Road, Nanshan District, Shenzhen 518057 China
3005599762
API
China
Sichuan Xieli Pharmaceutical Co., LTD.
Pharmaceutical Industrial Park Pengzhou 611930 China
3007432586
API
China
Visum Pharmaceutical Co., Ltd.
273-D, Nanhai Blvd., Haikou, Hainan 571100, China(CHN) China
3009283401
FDF
China
Xi'an Libang Pharmaceutical Co. Ltd. API Plant
No. 42, Fengchan Rd Wei Yang District Xi'an 710086 China
3003657863
API
China
Xinjiang Nuziline Bio-Pharmaceutical Co., Ltd.
252Km, 218 State Road, 835800 China China
3010738916
API
China
Yantai Dongcheng Biochemicals Co.,Ltd.
No.7, Changbaishan Road, Yantai Development Zone Yantai 264006 China
3004248487
API
China
Yiling Pharmaceutical Ltd
No. 36 Zhujiang Road Shijiazhuang 050035 China
3011640199
FDF
China
Yunnan Hande Bio-Tech Co., Ltd
No.3 Platform, Jinding Tech Zone, Kunming, Yunnan, P.R.China Kunming 650033 China
3002808537
API
China
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
333 Jiangnan Road, Hengdian Dongyang 322118 China
3003744129
API
China
Zhejiang Changmin Pharmaceutical Co. Ltd
No.1, Baidu Road Tiantai 317200 China
3006712427
API
China
Zhejiang Haisen Pharmaceutical Co., Ltd.
Xiangtan Village, Liushi Street Dongyang 322104 China
3003967524
API
China
Zhejiang Jinhua Conba Bio-Pharm. Co., LTD.
288 Jinqu Road, Jinhua City, Jinhua 321016 China
3003663281
API

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药士
 楼主| 发表于 2017-11-15 11:48:34 | 显示全部楼层
本帖最后由 beiwei5du 于 2017-11-15 11:55 编辑

2018年新增

new facilities which paied in FY2018.jpg
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药徒
发表于 2017-11-15 11:41:36 | 显示全部楼层
名单还是隐藏的。。。。
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药士
发表于 2017-11-15 16:22:59 | 显示全部楼层
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药徒
发表于 2018-1-15 21:44:14 | 显示全部楼层
先看看资料,感谢

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药圣
发表于 2023-1-11 19:14:48 | 显示全部楼层
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