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OTC manufacturers exporting to the U. S. Please note that FDA's annual registration update begins.
Release time:
2021-10-11 14:35
FDA OTC NDC manufacturers of disinfectant wipes, hand sanitizer and disinfectant spray exported to the United States, please pay attention! This year, the FDA's annual registration renewal period runs from October 1, 2021 to December 31, 2021. In order to maintain your current registration status for 2022, you must submit a registration update or no change notice during this period.
FDA Section 510 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) requires companies that manufacture, prepare, synthesize, or process pharmaceutical products in the United States or that are to be imported into the United States to register with FDA. These domestic and foreign companies must list at the time of registration all pharmaceutical products manufactured, prepared, compounded, or processed in the United States. In addition, foreign agencies must identify U.S. agents and importers at the time of registration.
At the time of registration, the information must include:
The name and DUNS number of the business;
Contact information for individuals responsible for receiving FDA communications related to the business;
Name and DUNS number for Chinese manufacturers, US agents and all importers.
If there are no changes to report, you can use a blanket no-change list to certify a structured product label (SPL) document. Any current Drug List file that has not been submitted or updated during the 2021 calendar year must be certified through a blanket no-change list certification SPL or by submitting a higher Drug List version.
Our services:
(1)FDA Registration Service
(2)FDA Annual Registration Update Service
(3) Annual listing certificate service
(4) Change of registration information
（5）Labeler Code 协助
(6) Dun & Bradstreet Number Assistance
New Anrun Chemical Regulations Advisory Services:
Declaration of new domestic chemical substances
Registration of hazardous chemicals and business license for hazardous chemicals
SDS/GHS Labeling
Declaration of cosmetic finished products and raw materials
EU REACH, Taiwan REACH, South Korea K-REACH Registration
Pharmaceutical, food contact materials regulatory consultation
Compliance services in countries where epidemic prevention materials are exported
Laboratory Testing Services
Environmental regulations consulting services
Including park environmental protection housekeeper, solid waste and hazardous waste comprehensive solution design, etc.
Contact: Miss Ann
Mobile phone number: 15801695345 (WeChat with the same number)
QQ: 1798064165
Electronic E-mail: nar@china-reach.net
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National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
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Tel:400 660 1329
E-mail：nar@china-reach.net
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