01 1BrightGene Pharmaceutical Co., Ltd
02 1Dasan Pharmaceutical Co., Ltd. @ [Product manufacturer] Shanghai Qingsong Pharmaceutical Co., Ltd.
03 1Dongbang FTL Co., Ltd. @Anhui Biochem Pharmaceutical co., Ltd.
04 1Estech Pharma Co., Ltd.
05 1Estifarm Co., Ltd.
06 1Hanseochem Co., Ltd. @ [Starting material manufacturer] Wujiang Xiehe Biochemicals Co., LTD @ [Raw material manufacturer] Zhejiang Warrant Pharmaceutical Co., Ltd._x000D_
07 1Hetero Drugs Limited
08 1Hwail Pharmaceutical Co., Ltd.
09 1Jeil Pharmaceutical Co., Ltd. @ [Second Method Raw Material Manufacturer] Lianyungang Guike Pharmaceutical Co., Ltd.
10 1SK Biotek Ireland Limited
11 1Samoh Pharmaceutical Co., Ltd.
12 1Siegfried Evionnaz SA
13 1Yeonseong Precision Chemical Co., Ltd.
01 1Dasan Pharmaceutical Co., Ltd.
02 1Dongbang FTL Co., Ltd.
03 1Estifarm Co., Ltd.
04 1Hanseochem Co., Ltd.
05 1Hwail Pharmaceutical Co., Ltd.
06 1Jeil Pharmaceutical Co., Ltd.
07 2Korea BMS Pharmaceutical Co., Ltd.
08 1Otran Pharm Korea Co., Ltd.
09 1Polaris AI Pharma Co., Ltd.
10 1Samoh Pharmaceutical Co., Ltd.
11 1Seongi Bio Co., Ltd.
12 1YS Life Science Co., Ltd.
01 12Entecavir
02 1Entecavir hydrate
01 1India
02 9South Korea
03 1Switzerland
04 1U.S.A
05 1Uzbekistan
Registrant Name : Dasan Pharmaceutical Co., Ltd.
Registration Date : 2011-06-30
Registration Number : 763-5-ND
Manufacturer Name : Dasan Pharmaceutical Co., Lt...
Manufacturer Address : 342 Deokamsan-ro, Dogomyeon, Asan-si, Chungcheongnam-do @ No.128 Chuhua Branch Road, ...
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2012-08-14
Registration Number : 1962-4-ND
Manufacturer Name : Estech Pharma Co., Ltd.
Manufacturer Address : 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2011-11-25
Registration Number : 787-2-ND
Manufacturer Name : Hanseochem Co., Ltd. @ [Star...
Manufacturer Address : Gyeonggi-do, Pyeongtaek-si, Poseung-eup, Poseung Industrial Complex Road 41@[Starting...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2015-07-27
Registration Number : Su5898-2-ND
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy. No. 213, 214 & 255, Bonthapally village, Gummadidala Mandal, Sangareddy District,...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2017-09-12
Registration Number : Su21-4-ND
Manufacturer Name : BrightGene Pharmaceutical Co...
Manufacturer Address : No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-11-18
Registration Number : Su2417-2-ND
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : 57, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2012-03-16
Registration Number : 711-12-ND
Manufacturer Name : Samoh Pharmaceutical Co., Lt...
Manufacturer Address : (429-852) 63, Okgucheonseo-ro 81beon-gil, Siheung-si, Gyeonggi-do
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2014-12-03
Registration Number : Su4095-10-ND
Manufacturer Name : Siegfried Evionnaz SA
Manufacturer Address : Route du Simplon 1, 36, 1902 Evionnaz, Switzerland_x000D_
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2013-06-11
Registration Number : 1301-2-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
Registrant Name : YS Life Science Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 767-2-ND
Manufacturer Name : Yeonseong Precision Chemical...
Manufacturer Address : (18581) 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do
A Entecavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entecavir, including repackagers and relabelers. The FDA regulates Entecavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entecavir 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 Entecavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entecavir supplier is an individual or a company that provides Entecavir active pharmaceutical ingredient (API) or Entecavir finished formulations upon request. The Entecavir suppliers may include Entecavir API manufacturers, exporters, distributors and traders.
click here to find a list of Entecavir 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 Entecavir Drug Master File in Korea (Entecavir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Entecavir. The MFDS reviews the Entecavir KDMF as part of the drug registration process and uses the information provided in the Entecavir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Entecavir 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 Entecavir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Entecavir suppliers with KDMF on PharmaCompass.
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