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2014财年仿制药厂商场地注册临近到期
Information including who is required to self-identify, how the information is submitted to FDA, the penalty for failure to self-identify, and the technical specifications are available on FDA’s GDUFA webpage.
FDA lists facilities that have successfully self-identified for fiscal year 2013 and fiscal year 2014 in a publicly available list, which is updated daily, at 1[1]
General questions should be sent to AskGDUFA@fda.hhs.gov. Technical questions related to submissions should be sent to CDEReFacility@fda.hhs.gov.
2013财年FDA场地注册已付费中国企业名单（141家，API 111家，FDF 20家，BOTH 10家）
| Type
| Facility FEI
| Facility Name
|
| API
| 3004752070
| FUJIAN FUKANG PHARMACEUTICAL CO LTD
|
| API
| 3003657686
| Fujian Kerui Pharmacetuical Co. Ltd.
|
| API
| 3006772356
| Livzon Group Fuzhou Fuxing Pharmaceutical Co.,Ltd.
|
| API
| 3004161427
| Fujian Kerui Pharmaceutical Co. Ltd
|
| API
| 3003675881
| Star Lake Bioscience Co., Inc.
|
| FDF
| 3007721552
| Sunshine Lake Pharma Co., Ltd.
|
| FDF
| 3008654998
| Pharmadax (Guanghzou) Inc.
|
| API
| 3002806661
| Changzhou Pharmaceutical Factory
|
| API
| 3007084224
| Guangdong Blue Treasure Pharmaceutical Co., Ltd.
|
| API
| 3005619530
| Livzon New North River Pharmaceutical Co., Ltd.
|
| API
| 3002808210
| SHENZHEN HEPALINK PHARMACEUTICAL CO LTD
|
| API
| 3005599762
| Shenzhen Techdow Pharmaceutical Co Ltd
|
| BOTH
| 3006040900
| CSPC Ouyi Pharmaceutical Co., Ltd.
|
| FDF
| 3008942524
| Zhuhai United Laboratories (Zhongshan) Co., Ltd
|
| FDF
| 3006689272
| Anshi Pharmaceutical (Zhongshan) Inc.
|
| BOTH
| 3006531950
| Zhuhai United Laboratories Co., Ltd
|
| FDF
| 3007972012
| Qilu Pharmaceutical (Hainan) Co., Ltd.
|
| FDF
| 3005115952
| Hainan Poly Pharm. Co., Ltd
|
| API
| 3009653722
| Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
|
| API
| 3005684109
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
| API
| 3003196232
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
| API
| 3005080039
| HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD
|
| FDF
| 2000021110
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
| API
| 3001164052
| HENAN LIHUA PHARMACEUTICAL CO., LTD.
|
| API
| 3007268407
| Hubei Granules Biocause Pharmaceutical Company Limited
|
| API
| 3004202226
| Wuhan Biocause Pharmaceutical Development Company Limited
|
| API
| 3001598425
| Wuhan Wuyao Pharmaceutical Co Ltd
|
| API
| 3006259537
| HEC PHARM CO LTD
|
| API
| 3008259813
| Yichang Changjiang Pharmaceutical Co Ltd
|
| API
| 3004753689
| Hunan Dongting Pharmaceutical Co., Ltd.
|
| API
| 3003091092
| Jilin Shulan Synthetic Pharma Ceutical Co., Ltd.
|
| API
| 3009853264
| ScinoPharm (Changshu) Pharmaceuticals, Ltd.
|
| API
| 3007515413
| Changzhou Yinsheng Pharmaceutical Co. Ltd.
|
| BOTH
| 3003844102
| Changzhou Siyao Pharmaceuticals Co Ltd
|
| FDF
| 3004079584
| Yung Shin Pharm. Ind. (Kunshan) Co., Ltd.
|
| API
| 3009530424
| Agno Pharma Jiangsu
|
| API
| 3009128843
| JARI PHARMACEUTICAL CORPORATION LIMITED
|
| API
| 3003663251
| Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| API
| 3007086869
| Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| API
| 3002807476
| Jiangsu Hengrui Medicine Co., Ltd.
|
| API
| 3003015655
| Lianyungang Runzhong Pharmaceutical Co.,Ltd.
|
| API
| 3005460102
| Sinopep Jiangsu Inc.
|
| BOTH
| 3006689263
| Jiangsu Hengrui Medicine Co., Ltd.
|
| FDF
| 3007373503
| Jiangsu Hengrui Medicine Co., Ltd.
|
| API
| 3009805706
| Amphastar Nanjing Pharmaceuticals, Inc.
|
| API
| 3004674350
| Nanjing Pharmaceutical Factory Co. Ltd.
|
| FDF
| 3006346108
| Novast Laboratories Ltd.
|
| API
| 3006895831
| Anhui Wanbei Pharmaceutical Company Ltd
|
| API
| 3009867839
| Bright-Gene Bio-Medical Technology Co. Ltd.
|
| API
| 3002808304
| Suzhou No.4 Pharmaceutical Factory
|
| FDF
| 3007751274
| Suzhou Amerigen Pharmaceutical Co. Ltd.
|
| BOTH
| 3004117396
| Novacyl (Wuxi) Pharmaceutical Co. Ltd.
|
| API
| 52928
| Joyang laboratories
|
| API
| 1000189256
| YANGZHOU PHARMACEUTICAL CO.,LTD
|
| API
| 3008177143
| JIANGXI FUSHINE PHARMACEUTICAL CO.,LTD.
|
| API
| 3006661959
| Jiangxi Tianxin Pharmaceutical Co., Ltd.
|
| API
| 3008465739
| Jiangxi Synergy Pharmaceutical Co.,Ltd.
|
| FDF
| 3004826096
| Merro Pharmaceutical Co., Ltd.
|
| FDF
| 3009810114
| Liaoning Chengda Biotechnology Co., Ltd
|
| API
| 3003862593
| Chifeng Arker Pharmaceutical Technology Co,
|
| API
| 1000390117
| Chifeng Pharmaceutical Co., Ltd.
|
| API
| 3004002973
| Jinan Jinda Pharmaceutical Chemistry Co. Ltd.
|
| BOTH
| 300426162
| Anqiu Luan Pharmaceutical Co Ltd
|
| API
| 3007187558
| Dongying Tiandong Pharmaceutical Co., Ltd
|
| API
| 3009831352
| Qilu Antibiotics Pharmaceutical Co., Ltd.
|
| API
| 3003674637
| Qilu Pharmaceutical Co., Ltd.
|
| BOTH
| 3004229375
| Qilu Tianhe Pharmaceutical Co., Ltd.
|
| FDF
| 3003802432
| Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
|
| API
| 3003877289
| Qilu Antibiotics(Linyi)Pharmaceutical Co.,Ltd.
|
| API
| 3006620786
| Qingdao Jiulong Biopharmaceutical Co., Ltd.
|
| API
| 3003941938
| Shouguang Fukang Pharmaceutical Co., Ltd.
|
| API
| 3002808153
| Shandong Xinhua Pharmaceutical Company Limited
|
| API
| 3004254526
| Shandong Xinhua Pharmaceutical Company Limited
|
| API
| 3007187281
| Shandong Xinhua Pharmaceutical Company Limited
|
| API
| 3005447913
| ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTD
|
| API
| 3005447913
| Zibo Xinhua-Perrigo Pharmaceutical Company Limited
|
| API
| 3004248487
| Yantai Dongcheng Biochemicals Co.,Ltd.
|
| API
| 3003657863
| Xian Libang Pharmaceutical Co. Ltd
|
| API
| 3002808514
| XIAN LIJUN PHARMACEUTICAL CO LTD
|
| API
| 3004567034
| SHANGHAI AJINOMOTO AMINO ACID CO LTD
|
| API
| 3006895951
| Shanghai Desano Chemical Pharmaceutical Co., Ltd. Binhai site
|
| API
| 3002806569
| SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD
|
| API
| 3002808134
| Shanghai Ziyuan Pharmaceutical Co Ltd
|
| API
| 3006986091
| Tai Heng Industry Co., Ltd.
|
| FDF
| 3004391730
| Shanghai Sine Pharmaceutical Laboratories Co.,Ltd
|
| FDF
| 3003910445
| Shanghai Hengrui Pharmaceutical Co., Ltd.
|
| FDF
| 3008865184
| Kanghong Sagent (Chengdu) Pharmaceuticals Co., Ltd.
|
| API
| 3007783546
| HUATAI BIOPHARM INC
|
| API
| 3002807489
| Sichuan Long March Pharmaceutical Co., Ltd.
|
| API
| 3006168710
| Sichuan Credit Chemwerth Pharmaceutical Co.,LTD.
|
| API
| 3005354924
| Asymchem Laboratories
|
| FDF
| 3007751421
| Tianjin Tianyao Pharmaceuticals Co.,Ltd.
|
| API
| 3008256667
| Tianjin Tianyao Pharmaceuticals Co., Ltd.
|
| API
| 3002808537
| Yunnan Hande Biotechnology Co., Ltd.
|
| API
| 3008465758
| Hangzhou Huadong Medicine Group Kangrun Pharmaceutical Co., Lt.d
|
| API
| 3004944662
| Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
|
| API
| 3003744129
| Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd.
|
| BOTH
| 3008481334
| Hisun Pharmaceutical (Hangzhou) Co., Ltd.
|
| API
| 3003995556
| Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
|
| API
| 3003878169
| Zhejiang Chiral Medicine Chemicals Co., Ltd
|
| FDF
| 3007498452
| Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
|
| API
| 3009271645
| Teva Pharmaceutical and Chemical (Hangzhou)
|
| API
| 3003194741
| Huzou Zhanwang Pharmaceutical Co. Ltd.
|
| API
| 3005289337
| Zhejiang Top Medicine Co., Ltd.
|
| API
| 3008304985
| Chengda Pharmaceuticals Co., LTD
|
| API
| 3005632618
| Zhejiang ChemPacific Corporation
|
| API
| 3003663281
| ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
|
| API
| 3006689170
| Zhejiang Huahai Pharmaceutical Co., Ltd.
|
| API
| 3002917378
| ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL CO., LTD.
|
| BOTH
| 3003999190
| Zhejiang Huahai Pharmaceutical Co., Ltd.
|
| API
| 3004160744
| Ningbo Renjian Pharmaceutcal Group Co Ltd
|
| API
| 3008512330
| Zhejiang Qiming Pharmaceutical Co., Ltd.
|
| API
| 3004986788
| MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTD
|
| API
| 3005183062
| Zhejiang Supor Pharmaceuticals Co., Ltd.
|
| API
| 3006364492
| Xellia Pharmaceuticals Co Ltd
|
| API
| 3005280475
| Zhejiang Excel Pharmaceutical Co. Ltd
|
| API
| 3003735151
| Zhejiang Hisoar Pharmaceutical Co., Ltd.
|
| API
| 2000031510
| ZHEJIANG HISYN PHARMACEUTICAL CO., LTD.
|
| API
| 3003744377
| Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
|
| API
| 3004414647
| Zhejiang Neo-Dankong Pharmaceutical Co., Ltd.
|
| API
| 3005463252
| ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD
|
| BOTH
| 3007719313
| Zhejiang Hisun Pharmaceutical Co., Ltd.
|
| API
| 3006712427
| ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD
|
| API
| 3003701917
| Zhejiang Candorly Pharmaceutical Co Ltd
|
| API
| 3004090742
| Zhejiang Cheng Yi Pharmaceutical Co., Ltd
|
| API
| 3003311250
| Zhejiang Kangle Pharmaceutica Co Ltd
|
| API
| 3002808516
| Zhejiang Charioteer Pharmaceutical Co., Ltd.
|
| API
| 3003663256
| Zhejiang Xianju Pharmaceutical Co., Ltd.
|
| API
| 3003631275
| Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
|
| API
| 3003657871
| Zhejiang Huayi Pharmaceutical Co., Ltd.
|
| API
| 3005256542
| Chongqing Carelife Pharmaceutical Co Ltd
|
| API
| 3002806683
| Chongqing Daxin Pharmaceutical Co. Ltd
|
| API
| 3007378822
| CHONGQING KANGLE PHARMACEUTICAL LTD
|
| API
| 3006560479
| Chongqing Lummy Pharmaceutical Co., Ltd
|
| API
| 3001204127
| Chongqing Pharmaceutical Research Institute Co Ltd
|
| API
| 3006810051
| Chongqing Shenghuaxi Pharmaceutical Co., Ltd.
|
| API
| 3006088309
| ChongQing Taihao Pharmaceutical Co. Ltd (Polymed Therapeutics Inc. China Division)
|
| API
| 3003723024
| No 1 Branch Plant of Southwest Synthetic Pharmaceutical Corp Ltd
|
| API
| 3006305268
| Porton Pharmaceutical Ltd.
|
| API
| 3003094545
| Southwest Synthetic Pharmaceutical Corp Ltd
|
| FDF
| 3008309828
| Yaopharma Co. Ltd
|
