01 1Estechpharma
02 1Hamari chemicals
03 1Sanwa Kagaku Kenkyusho
04 1Yantai Valiant Fine Chemicals
05 1Yonezawa Hamari Chemicals\
06 1Zhejiang Hisun Chemical Co., Ltd.
07 1Blank
01 2China
02 3Japan
03 1South Korea
04 1Blank
01 1Inactive
02 6Blank
01 7Blank
01 1219MF10133
02 1223MF10167
03 1226MF10226
04 1304MF10001
05 1306MF10058
06 2Blank
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21259
Submission : 2008-01-14
Status : Inactive
Type : II
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2008-01-28
Registration Number : No. 4827-1-ND
Manufacturer Name : Yonezawa Hamari Chemicals Ltd.
Manufacturer Address : 4300-18, 2-Chome, Hachimanpara, Yonezawa-city, Yamagata
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 306MF10058
Registrant's Address : No. 60 Taiyuan Rd. , Dajijia Industrial Park, YEDA Yantai, Shandong China
Initial Date of Registration : 2024-04-18
Latest Date of Registration : --
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Registration Number : 226MF10226
Registrant's Address : No. 60 Taiyuan Rd. , Dajijia Industrial Park, YEDA Yantai, Shandong China
Initial Date of Registration : 2014-12-08
Latest Date of Registration : --
Registration Number : 219MF10133
Registrant's Address : 24-8 Tamura 9-chome, Hiratsuka City, Kanagawa Prefecture
Initial Date of Registration : 2007-04-18
Latest Date of Registration : --
Registration Number : 223MF10167
Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture
Initial Date of Registration : 2011-12-05
Latest Date of Registration : --
Registration Number : 304MF10001
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2022-01-11
Latest Date of Registration : --
A Polaprezinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polaprezinc, including repackagers and relabelers. The FDA regulates Polaprezinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polaprezinc API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Polaprezinc supplier is an individual or a company that provides Polaprezinc active pharmaceutical ingredient (API) or Polaprezinc finished formulations upon request. The Polaprezinc suppliers may include Polaprezinc API manufacturers, exporters, distributors and traders.
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