01 1Anhui Heryi Pharmaceutical Co., Ltd@Daewoong Bio Co., Ltd
02 3Beijing Union Pharmaceutical Factory
03 1Beijing Union Pharmaceutical Factory@Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.
04 1Hanseochem Co., Ltd.
05 1Korea Biochem Pharmaceutical Co., Ltd.
06 1Samjin Pharmaceutical Co., Ltd. @ [Product Manufacturing Plant] Hanseo Chem Co., Ltd.
07 1Wanbangde Pharmaceutical Group Co., Ltd.
08 2Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.
09 1Zhejiang Hisoar Pharm Co., Ltd.
10 1[Starting material (biphenyl dimethyl dicarboxylate) manufacturing plant②] Wanbangde Pharmaceutical Group Co., Ltd. @ Polaris AI Pharma Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1DBS Farm Co., Ltd.
03 1Daewoong Bio Co., Ltd.
04 1Farm & Biz Co., Ltd.
05 1Hanseochem Co., Ltd.
06 2Hwail Pharmaceutical Co., Ltd.
07 1Korea Biochem Pharmaceutical Co., Ltd.
08 1Korea Chorus Co., Ltd.
09 1Korea Hutex Pharmaceutical Co., Ltd.
10 1Polaris AI Pharma Co., Ltd.
11 1Samjin Pharmaceutical Co., Ltd.
12 1Samwon Pharmaceutical Co., Ltd.
01 12Biphenyl dimethyl dicarboxylate
02 1Biphenyl dimethyl dicarboxylate ring
01 10China
02 3South Korea
Biphenyl dimethyl dicarboxylate
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-17-C-401-14
Manufacturer Name : Anhui Heryi Pharmaceutical C...
Manufacturer Address : Industrial park, Yangcun town, Tianchang city, Anhui province, China@29, Yakjedanji-r...
Biphenyl dimethyl dicarboxylate
Registrant Name : Korea Hutex Pharmaceutical Co., Ltd.
Registration Date : 2013-05-22
Registration Number : 20070328-17-C-217-06(3)
Manufacturer Name : Beijing Union Pharmaceutical...
Manufacturer Address : North Xingye Road, Huangcun Town, Da Xing County, Beijing 102600, China
Biphenyl dimethyl dicarboxylate ring
Registrant Name : Samwon Pharmaceutical Co., Ltd.
Registration Date : 2022-01-04
Registration Number : 20220104-17-C-399-13
Manufacturer Name : Beijing Union Pharmaceutical...
Manufacturer Address : No. 37, Yongwang Road, Bio–medicine Industry Park, Daxing District, Beijing 102600,...
Biphenyl dimethyl dicarboxylate
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2015-01-20
Registration Number : 20150120-17-C-347-09
Manufacturer Name : Hanseochem Co., Ltd.
Manufacturer Address : 41 Poseung Industrial Complex-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Biphenyl dimethyl dicarboxylate
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2017-04-05
Registration Number : 20170405-17-C-363-11
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
Biphenyl dimethyl dicarboxylate
Registrant Name : Samjin Pharmaceutical Co., Ltd.
Registration Date : 2014-11-28
Registration Number : 20141128-17-C-336-08
Manufacturer Name : Samjin Pharmaceutical Co., L...
Manufacturer Address : 156 Osong Life 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do @ [Produ...
Biphenyl dimethyl dicarboxylate
Registrant Name : Farm & Biz Co., Ltd.
Registration Date : 2013-12-20
Registration Number : 20131220-17-C-309-07
Manufacturer Name : Wanbangde Pharmaceutical Gro...
Manufacturer Address : No.18, Beisha Road, Shitang Town, Wenling City, Taizhou City, Zhejiang, China
Biphenyl dimethyl dicarboxylate
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2016-04-19
Registration Number : 20160419-17-C-351-10
Manufacturer Name : [Starting material (biphenyl...
Manufacturer Address : No.18, Beisha Road, Shitang Town, Wenling City, Taizhou City, Zhejiang, China@25, Bal...
Biphenyl dimethyl dicarboxylate
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2019-01-31
Registration Number : 20190131-17-C-373-12
Manufacturer Name : Zhejiang Hisoar Chuannan Pha...
Manufacturer Address : No 23. Donghai 5th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Linhai City,...
Biphenyl dimethyl dicarboxylate
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-09-15
Registration Number : 20190131-17-C-373-12(1)
Manufacturer Name : Zhejiang Hisoar Chuannan Pha...
Manufacturer Address : No 23. Donghai 5th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Linhai City,...
A Bifendate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bifendate, including repackagers and relabelers. The FDA regulates Bifendate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bifendate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Bifendate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bifendate supplier is an individual or a company that provides Bifendate active pharmaceutical ingredient (API) or Bifendate finished formulations upon request. The Bifendate suppliers may include Bifendate API manufacturers, exporters, distributors and traders.
click here to find a list of Bifendate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bifendate Drug Master File in Korea (Bifendate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bifendate. The MFDS reviews the Bifendate KDMF as part of the drug registration process and uses the information provided in the Bifendate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bifendate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bifendate API can apply through the Korea Drug Master File (KDMF).
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