FDA GDUFA设施注册费拖欠名单（2017.09.27）

beiwei5du

FDA GDUFA设施注册费拖欠名单（2017.09.27）
Beijing Taiyang Pharmaceutical Industry Co.,Ltd.
Chongqing Lummy Pharmaceutical Co., Ltd.
Chongqing Shenghuaxi Pharmaceutical Co Ltd
Jiangsu ZW Pharmaceuticals Co., Ltd.
Shanghai Sine Pharmaceutical Corp. LTD
Taizhou Taifa Pharmaceuticals Co. Ltd.
Wuxi Kaili Pharmaceutical Company LTD.


补充内容 (2017-10-15 10:01):
这个应该是针对于2017年的

beiwei5du

2018 财年 GDUFA 年费的最后支付期限：10月23日

2017-10-14 识林

我们都知道 GDUFA II 的新收费表，其中包括：一次性收费（ANDA 申请费和 DMF 申请费）以及年度收费（API 和 FDF 场地费，ANDA 持有人费）。

ANDA 申请费的支付时间安排是在 ANDA 提交之时。而年度项目费、API 和 FDF 场地费的支付是在每财年的 10 月 1 日，有 20 天的宽限期。因此，2017 年 10 月 23 日，年度项目费支付最后日期逐渐迫近。如果年费没有按时支付，那么公司将会进入拖欠费用名单，并且如果当有 ANDA 进行可接受评估时仍未支付费用，任何已经提交但尚未立卷的 ANDA 将收到拒绝接收（RTR）函。

如普享药协会（AAM）的 Lisa Parks 在一封邮件中向 AAM 工作组指出的那样：

您将了解到年度收费将在每个新财年的 10 月 1 日到期。GDUFA 法规确实允许对于支付这些费用的公司在实施处罚（例如，拒绝接收 ANDA）之前从每财年开始日期有 20 天的“宽限期”。那么这意味着什么，为什么这些日期是重要的？让我们举个例子来说明一下。

• FDA 于 2017 年 8 月发布 2018 财年收费标准。
• 企业在 10 月 23 日之前（因为 10 月 1 日是周日，是从首个工作日开始 20 天的时间，而 10 月 22 日也是周日，因此是 10 月 23 日）可以支付费用，在这种情况下指的是年度费用，因为一次性费用，也就是申请费是在提交时支付的。
• 如果在 10 月 23 日之前未满足年费义务，ANDA 申办人及其关联公司对于那些尚未被 FDA 接受的任何已提交的申请将会收到与费用相关的RTR。
• 费用相关的 RTR = 不退还已支付的申请费，ANDA 申办人如果重新提交 ANDA，则必须支付新的 2018 财年费用，并且申办人将错过提交日期。
• 一旦申办人通过支付费用满足了付费义务，ANDA 将有资格由仿制药办公室（OGD）立卷审查部门进行评估，并将重新调整提交日期以反映满足付费义务的日期。
  
  

为什么这一事实是重要的？因为 OGD 在 9 月份收到了创纪录的 ANDA 提交。鉴于 OGD 有大约 60 天的时间做出立卷决定，上述情况可能会损害您的提交日期，以及您在 9 月份对任何尚未收到立卷决定的 ANDA 支付的申请费。

因此，底线是，请确保您的公司已经支付了所有年费账单，以避免不必要的头痛。在这里重申一遍，年费是 API 和 FDA 场地费以及 ANDA 持有人费。这一点非常重要，因为 10 月份的日期非常接近了，任何首次提交的机会都可能会因为未能及时向 FDA 支付年费而丢失。

【相关阅读】

FDA 公布 2018 财年 GDUFA 费率 2017/08/28

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒

参考资料

• URGENT: October 23, 2017 is a Very Important Date – Ignoring it Could Cost You Dearly
  
  

beiwei5du

为什么今年截止到2017.10.13缴费企业共计123家（期限应该不长了），较2017年188家,216年183家以及2015年的181家均少，时间不多了啊！
其实个人觉得2018年的在2018年10月1日之前都可以交吧，但是可能会影响关联的ANDA厂家？？？

	GDUFA FACILITY PAYMENTS LIST AS OF 10/13/2017截止2017.10.13,GDUFA设施注册费用已缴费场地设施列表
Fiscal Year	Facility Name	Facility Address	Facility FEI	Facility Type
2018	Amphastar Nanjing Pharmaceuticals, Inc.	No.5 Xinghe Road Nanjing 210038 China	3009805706	API
2018	Anqiu Luan Pharmaceutical Co Ltd	No. 35, Weixu North Road Anqiu 262100 China	3004261627	BOTH
2018	Anshi Pharmaceutical (Zhongshan) Inc.	No. 7 Huiling Rd., Inside NHTP (National Health Technology Park), Torch Development Zone Zhongshan 528437 China	3006689272	FDF
2018	Aurisco Pharmaceutical Co., Ltd.	Badu Industrial Park Zone, Tiantai 317200 China	3005793293	API
2018	BrightGene Fine Chemical Co., Ltd.	No. 22 Binjiang South Road, Taixing Economic Development Zone Taizhou 225442 China	3011254184	API
2018	BrightGene Pharmaceutical Co., Ltd.	No. 218 Xinghu Road, Suzhou Industrial Park Suzhou 215123 China	3009867839	API
2018	Changzhou Pharmaceutical Factory	No.518 Laodong East Road Changzhou 213018 China	3002806661	BOTH
2018	CHANGZHOU QIANHONG BIOPHARMA CO LTD	No.192 Huanghe West Road, Xinbei District, Changzhou Jiangsu 213032 China China	3005275502	API
2018	Changzhou Yinsheng Pharmaceutical Co. Ltd.	Weitang Chemical zone, Xinbei district, Changzhou 213033 China	3007515413	API
2018	Chengda Pharmaceuticals Co., LTD.	No.5, Hengshan Road, United Development Zone, Jiashan, Zhejiang, 314100, P.R. China China	3004248447	API
2018	Chengdu Shengnuo Biopharm Co., Ltd.	Section 1, Gongye Avenue, Dayi County, Chengdu, Sichuan 611330, China China	3006257504	API
2018	Chongqing Carelife Pharmaceutical Co., Ltd.	3 Hua Nanyi Road,Chongqing (Changshou) Chemical Industry Park Chongqing 401254 China	3005256542	API
2018	Chongqing Daxin Pharmaceutical Co. Ltd.	No. 22 Chuangzao Road, BeiBei District Chongqing 400700 China	3002806683	API
2018	Chongqing Daxin Pharmaceutical Co. Ltd.	No. 21, Founder Road, Shuitu Town, BeiBei District Chongqing City 400714 China	3000291692	API
2018	Chongqing Taihao Pharmaceutical Co., Ltd. (A Division of Polymed Therapeutics, Inc.)	No.105, Chuangye Road, Erlang Jiulongpo District 400039 China	3006088309	API
2018	CSPC Ouyi Pharmaceutical Co., Ltd.	No. 99 Hainan Road, High-tech Industry Zone Shijiazhuang 052165 China	3010849184	API
2018	CSPC Ouyi Pharmaceutical Co., Ltd.	No.88 Yangzi Road, Economic and Technical Development Zone Shijiazhuang 052160 China	2000021110	FDF
2018	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	No.88 Yangzi Road Economic & Technological Development Zone Shijiazhuang 052160 China	3010166013	FDF
2018	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	No. 47 Fengshou Road Shijiazhuang 050041 China	3003196232	API
2018	CSPC-NBP Pharmaceutical Co., Ltd.	No.88 Yangzi Road, Economic and Technological Development Zone Shijiazhuang 052160 China	3007221763	FDF
2018	Esteve Huayi Pharmaceutical Co., Ltd	Linhai Rd., Shaoxing Paojiang Industrial Zone Shaoxing 312071 China	3008705620	API
2018	Evonik Rexim (Nanning) Pharmaceutical Co. Ltd.	10 Wenjiang Road Nanning 530100 China	3004268442	API
2018	FUJIAN FUKANG PHARMACEUTICAL CO., LTD.	Jiangyin Industrial Estate Fuqing 350309 China	3004752070	API
2018	Fujian Kerui Pharmaceutical Co., Ltd.	Yuanzai Industry Village, Haikou Fuqing 350313 China	3003657686	API
2018	Guangdong Blue Treasure Pharmaceutical Co., Ltd.	Renmin One Road Qingyuan 511515 China	3007084224	API
2018	Guilin Pharmaceutical Co., Ltd.	No.43, Qilidian Road Guilin 541004 China	3002807125	API
2018	Hainan Poly Pharm. Co., Ltd.	Guilinyang Economic Development Area Haikou 571127 China	3005115952	BOTH
2018	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd	658 Bin'an Road Binjiang District China 310051 China	3007498452	FDF
2018	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd	No. 866 Moganshan Road Hangzhou 310011 China	3003995556	API
2018	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd	No. 866 Moganshan Road Hangzhou 310011 China	3003995556	FDF
2018	HEC PHARM CO., LTD	No. 62 Binjiang Road, Yidu City, Hubei Province 443300 China	3006259537	API
2018	Henan Lihua Pharmaceutical Co., Ltd	Middle of Huanghe Street, Anyang Hi-tech Industry Development Zone Anyang 455000 China	3001164052	API
2018	Hisun Pharmaceutical (Hangzhou) Co., Ltd.	Xialian Village, Xukou Town, Fuyang District Hangzhou China	3008481334	API
2018	HUBEI HAOSUN PHARMACEUTICAL CO LTD	No.20, Juxian Rd. Gedian Economic Technology Development Zone 436070 China	3005178749	API
2018	Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd	No.99, 2nd Shendun Road Wuhan 430206 China	3010163919	FDF
2018	Hunan Dongting Pharmaceutical Co., Ltd.	No. 16 Dongyan Road, Deshan Changde City 415001 China	3004753289	API
2018	Huzhou Zhanwang Pharmaceutical Co., Ltd.	West Development Area Rd Linghu Town, Huzhou 313018 China	1000613242	API
2018	Hybio Pharmaceutical Co., Ltd	37 Keji C, Str 2nd Shenzhen 518057 China	3010165930	API
2018	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.	Kaitai Road Lianyungang 222000 China	3007086869	API
2018	Jiangsu Hengrui Medicine Co., Ltd.	38 Huanghe Road Lianyungang 222047 China	3007373503	FDF
2018	Jiangsu Hengrui Medicine Co., Ltd.	22 Jinqiao Road, Lianyungang 222002 China	3006689263	BOTH
2018	Jiangxi Fushine Pharmaceutical Co., Ltd.	No. 2 Yuli Industrial Zone, Changjiang District Jingdezhen 333000 China	3008177143	API
2018	Jiangxi Synergy Pharmaceutical Co.,Ltd	Jiangxi Fengxin Industrial Park Fengxin 330700 China	3008465739	API
2018	Jiangxi Tianxin Pharmaceutical Co., Ltd.	Le'anjiang Industrial Zone Leping 333300 China	3006661959	API
2018	Jinan Jinda Pharmaceutical Chemistry Co. Ltd	No. 6121 Longquan Road Zhangqiu City 250200 China	3004002973	API
2018	Kindos Pharmaceuticals Co., Ltd.	No.8-9 Kexin Road, Chengdu Hi-Tech Comprehensive Bonded Zone Chengdu 611731 China	3008865184	FDF
2018	Lianyungang Runzhong Pharmaceutical Co., Ltd.	No. 16 Jinqiao Rd., Dapu Industrial Park, Economic Technology Development Zone, Lianyungang, Jiangsu, 222069, China China	3003015655	API
2018	Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.	Jiangyin Industrial Concentration Zone, Fuqing Fuzhou City 350309 China	3006772356	API
2018	Livzon New North River Pharmaceutical Co., Ltd.	Renmin One Road, Qingyuan City, Guangdong Province, P. R. China 511515 Qingyuan 511515 China	3005619530	API
2018	Livzon Ningxia New North River Pharmaceutical Co., Ltd.	Toushi Road West, 301 Provincial Highway South, Pingluo Industrial Park, Ningxia, P. R. China 753400 China	3012375554	API
2018	Merro Pharmaceutical Co., Ltd.	9 Yingsheng Road Dalian 116036 China	3004826096	FDF
2018	MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD.	No. 315 Tanggong Road, Paojiang Industrial Zone Shaoxing 312071 China	3004986788	API
2018	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	No. 16, Xuefu Road, Nanjing High and New Technology Development Zone Nanjing 210061 China	3010625707	FDF
2018	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	MA010-1, Nanjing High and New Technology Development Zone Nanjing 210061 China	3004664441	API
2018	Nantong Chanyoo Pharmatech Co., Ltd	No.2 Tonghai Si Road Rudong County Nantong 226407 China	3011243688	API
2018	Ningxia Qiyuan Pharmaceutical Co., Ltd.	No.1 Qiyuan Street, Wangyuan Industrial Area Yinchuan 750101 China	3004341367	API
2018	Novacyl Wuxi Pharmaceutical Co. Ltd.	No. 8 Guangshi Xi Road Wuxi 214185 China	3004117396	BOTH
2018	Novast Laboratories Ltd.	1 Guangxing Road, Free Trade Zone, NETDA Nantong China	3006346108	FDF
2018	Pharmadax (Foshan) Co.,Ltd.	Dachong Industrial Zone, Lishui Town, Nanhai District Foshan 528244 China	3008654992	FDF
2018	Qilu Antibiotics Pharmaceutical Co., Ltd.	No. 849 Dongjia Town, Licheng District Jinan 250105 China	3009831352	API
2018	Qilu Pharmaceutical (Hainan) Co., Ltd.	No.273-A, Nanhai Avenue, National High-Tech Zone Haikou 570314 China	3008250362	FDF
2018	Qilu Pharmaceutical Co., Ltd.	No. 243 Gong Ye Bei Road Jinan 250100 China	3003674637	BOTH
2018	Qilu Pharmaceutical Co., Ltd. (High Tech Zone site)	No. 317 Xinluo Road, High-tech Zone Jinan 250101 China	3003802432	FDF
2018	Qilu Tianhe Pharmaceutical Co., Ltd.	No.849 Dongjia Town, Licheng District, China	3004229375	BOTH
2018	Qingdao BAHEAL Pharmaceutical Co.,Ltd.	No 268.Yingcheng Road, Jimo Qingdao 266200 China	3011922870	FDF
2018	Qingdao Jiulong Biopharmaceutical Co., Ltd.	Jiulong Industry Park Jiaozhou 266319 China	3006745882	API
2018	RUYUAN HEC PHARM CO., LTD	Xiaba Development Zone, Ruyuan County Shaoguan 512721 China	3009740510	API
2018	SciAnda (Changshu) Pharmaceuticals, Ltd.	No. 16, Dong Zhou Road, Economic Development Zone Changshu 215513 China	3009853264	API
2018	Shandong Keyuan Pharmaceutical Co.,Ltd.	Keyuan Street Jinan 251601 China	3007607025	API
2018	Shandong New Time Pharmaceutical Co., Ltd.	No.1, North Outer Ring Road, Feixian County, Shandong 273400, China Linyi 273400 China	3006704412	API
2018	Shandong Xinhua Pharmaceutical Company Limited	East Chemical Zone of Zibo High, New Technology Zibo 255075 China	3002808153	API
2018	Shandong Xinhua Pharmaceutical Company Limited	Hutian Chemical Industrial Zone Zibo 255075 China	3004254526	API
2018	Shanghai AmbioPharm, Inc.	No.388 Chugong Road Shanghai Chemical Industrial Park China	3006494603	API
2018	Shanghai Desano Chemical Pharmaceutical Co., Ltd.	No. 417 Binhai Rd, Laogang Town, Pudong New Area Shanghai 201302 China	3006895951	API
2018	Shanghai Hengrui Pharmaceutical Co., Ltd.	279 Wenjing Road Shanghai 200245 China	3003910445	FDF
2018	Shanghai Shyndec Pharmaceutical Haimen Co Ltd	No.1, Linjiang Avenue, Linjiang Town Jiangsu Haimen 226133 China	3008245746	API
2018	Shanghai Ziyuan Pharmaceutical Co. Ltd.	749 Guanghua Rd Shanghai 201108 China	3002808134	API
2018	Shenzhen Hepalink Pharmaceutical Group Co., Ltd.	21 Langshan Road, Songpingshan, Nanshan District Shenzhen 518057 China	3002808210	API
2018	Shouguang Fukang Pharmaceutical Co., Ltd.	North-East of Dongwaihuan Road,DongCheng Industrial Area Shouguang 262700 China	3003941038	API
2018	Sichuan Credit ChemWerth Pharmaceutical Co., Ltd	Industrial park, Fuji Town, Lu County 646106 China	3006168710	API
2018	Sichuan Long March Pharmaceutical Co., Ltd.	448 Changqing Road Leshan 614000 China	3002807489	API
2018	Sinopep-Allsino Biopharmaceutical Co., Ltd.	No.28,Linpu Road Lianyungang 222000 China	3005460102	API
2018	Sinopharm Weiqida Pharmaceutical Co., Ltd.	Economic&Technological Development Zone, First Medical Zone Datong 037300 China	3010166430	API
2018	Star Lake Bioscience Co., Inc.	67 Gongnong Road, North Zhaoqing 526060 China	3003675881	API
2018	Suzhou Amerigen Pharmaceutical Co. Ltd.	No 58 Qun Xing Yi Road Suzhou 215006 China	3007751274	FDF
2018	Tai Heng Industry Co., Ltd	Building 2, Shanghai Juke Biotech Park, No. 2715, Longwu Road Shanghai 200231 China	3006986091	API
2018	Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.	No. 1889, Jingliu Road, Linjiang Industrial Zone, Xiaoshan Hangzhou 311228 China	3009271645	API
2018	Tianjin Tianyao Pharmaceuticals Co., Ltd.	No 19 Xinye 9th street, wes area of Tianjin Economic-Technological Development Area Tianjin 300462 China	3008256667	API
2018	Tianjin Tianyao Pharmaceuticals Co., Ltd.	No 221 Huanghai Road, Tianjin Economic-Technological Development area Tianjin 300457 China	3007751421	FDF
2018	Tianjin Weijie Pharmaceutical Co., Ltd.	No. 28 Qixia Street, Hangu Modern Industry Park TEDA 300480 China	3005526021	API
2018	Wuhan Biocause Pharmaceutical Development Company Limited	Hi-Tech Industrial Park, Building #1 Wuhan City 430056 China	3004202226	API
2018	Xellia (Taizhou) Pharmaceuticals Co., Ltd.	108 Binhai Road Taizhou Zhejiang China	3007422723	API
2018	Xiamen LP Pharmaceutical Co., Ltd.	2010 Wengjiao West Road Xiamen 361027 China	3013002864	FDF
2018	Yabao Pharmaceutical Co., Ltd. Beijing	97 Kechuang East 6th Street, BDA Beijing 101111 China	3009071264	FDF
2018	YANGZHOU PHARMACEUTICAL CO., LTD.	7, SOUTH WENFENG ROAD, YANGZHOU 225009 China	1000189256	API
2018	Yaopharma Co., Ltd.	No.100, Xingguang Avenue Chongqing 401121 China	3008309828	FDF
2018	YiChang HEC ChangJiang Pharmaceutical Co.,Ltd.	No.38&62 BinJiang Road Yidu 443300 China	3008259813	API
2018	Yichang Humanwell Oral Solid Dosage Plant	No. 519, Donglin Road 443112 China	3008984460	FDF
2018	Yung shin Pharm. Ind.(Kunshan)Co.,Ltd	No.191 JIn Yang West Road ,Lujia Kunshan 215331 China	3004079584	FDF
2018	ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL COMPANY LIMITED	Hengdian Industrial Zone Dongyang 322118 China	3004944662	API
2018	Zhejiang Ausun Pharmaceutical Co., Ltd.	No.5, Donghai 4th Avenue, Taizhou 317015 China	3009065969	API
2018	Zhejiang Charioteer Pharmaceutical Co., Ltd.	Tongyuanxi, Dazhan, Xianju Zhejiang 317321 China China	3002808516	API
2018	ZHEJIANG CHEMPACIFIC	East Blvd, Jiaxing Port, Zhapu Jiaxing 314201 China	3005632618	API
2018	ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD	118 Hua Gong Road, Dongtou District Wenzhou 325700 China	3004090742	API
2018	Zhejiang Chiral Medicine Chemicals Co., Ltd	Nanyang Economy Development Zone, Xiaoshan Hangzhou 311227 China	3003878169	API
2018	Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.	No. 23, Donghai 5th Ave., Zhejiang Chemical Materials Base Linhai Zone Taizhou 317016 China	3006545436	API
2018	Zhejiang Hisoar Pharmaceutical Co., Ltd.	No. 100 Waisha Branch Rd., Jiaojiang District Taizhou 318000 China	3003735151	API
2018	Zhejiang Hisun Pharmaceutical Co., Ltd.	46 Waisha Road, Jiaojiang District Taizhou China	3007719313	API
2018	Zhejiang Huahai Pharmaceutical Co., Ltd.	Coastal Industrial Zone Linhai 317016 China	3003885745	API
2018	Zhejiang Huahai Pharmaceutical Co., Ltd.	Xunqiao Town Linhai 317024 China	3003999190	BOTH
2018	Zhejiang Huayi Pharmaceutical Co., Ltd.	No. 15, Shuangfeng Rd, Fotang Yiwu 322002 China	3003657871	API
2018	Zhejiang Jiangbei Pharmaceutical Co., Ltd.	Dongdai Zhang'an Taizhou 318017 China	3004986814	API
2018	Zhejiang Jiuzhou Pharmaceutical Co., Ltd.	Waisha Road 99 Taizhou City 318000 China	3003744377	API
2018	Zhejiang Langhua Pharmaceutical Co., Ltd.	No. 7, Donghai 3rd Avenue Linhai 317016 China	3005289386	API
2018	Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory	98 East Xinchang Dadao Road Xinchang 312500 China	3003631275	API
2018	Zhejiang Neo-Dankong Pharmaceutical Co., Ltd.	No. 259, Binhai Road, jiaojiang District Taizhou 318000 China	3004414647	API
2018	ZHEJIANG SANCUS ARC BIOCHEMICAL TECHNOLOGY CO LTD	No.8-8, Weiwu Road, Hangzhou Bay, Shangyu Economic and Technological Development Area, Shaoxing City, Zhejiang Province, PR China 312369 China	3011792624	API
2018	Zhejiang Shenzhou Pharmaceutical Co., Ltd	No 14 Chuancheng Nan Road, Xianju Taizhou 317300 China	3005463252	API
2018	Zhejiang Supor Pharmaceuticals Co., Ltd	Yuedong Road, Paojiang Industrial Zone, Shaoxing, Zhejiang Shaoxing 312071 China	3005183062	API
2018	Zhejiang Tianyu Pharmaceutical Co., Ltd.	Jiangkou Development Zone, Huangyan, Taizhou 318020 China	3010972581	API
2018	Zhejiang Yongtai Pharmaceutical Co., Ltd.	No.1, 4th Donghai Road, Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Linhai 317016 China	3008828051	API
2018	Zhuhai United Laboratories Co. Ltd.	No. 2428, Anji Road, Sanzao Town, Jinwan District Zhuhai 519040 China	3006531950	API
2018	Zibo Xinhua-Perrigo Pharmaceutical Co., Ltd.	No.13 Huagong Road, Chemical Area, Zibo High-Tech Development Zone Zibo 255000 China	3005447913	API

beiwei5du

这个时间逻辑关系还是不是很理解

beiwei5du

Q8. What is the penalty for failure to pay a facility fee?

There are several consequences for failure to pay a facility fee. The facility will be placed on a publicly available arrears list if the fee is not fully paid within 20 days of the due date. No new generic drug submission referencing the facility will be received until the fee is paid. Furthermore, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility will be deemed misbranded. This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products misbranded because of failure to pay facility fees are subject to being denied entry into the United States.

Note: The fee is an obligation to the U.S. government, and the failure to pay the fee may result in collection activities by the government pursuant to applicable laws.
那么这种情况下，如果有制剂企业使用到这些API厂家的原料药，那么在2017.10.01前就不能再使用这些厂家的原料药了（即使自己库存中有这些厂家的API）

syhorchid

了解一下

套路

学习借鉴，感谢楼主

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