01 1BrightGene Bio-Medical Technology Co. , Ltd.
02 1Chungking Carelife Pharmaceutical Co., Ltd.
03 1DONGBANG FUTURE TECH & LIFE CO. , LTD.
04 1ESTECHPHARMA CO. , LTD.
05 1Eurofins CDMO Alphora Inc.
06 1JEIL PHARMACEUTICAL CO. , LTD.
07 1Kyongbo Pharmaceutical Co. , Ltd.
08 1Polaris AI Pharma Corp.
09 1YS Life Science Co. , Ltd.
10 1Yung Shin Pharmaceutical Ind. Co. , Ltd.
11 1Zhejiang Ausun Pharmaceutical Co. , Ltd.
12 1Zhejiang Ouxiang Pharmaceutical Co., Ltd.
01 3Entecavir
02 4Entecavir hydrate
03 1Entecavir hydrate
04 1Entecavir intermediate (ET1)
05 3Entecavir monohydrate
01 1Canada
02 4China
03 1Gabon
04 6South Korea
Registration Number : 228MF10043
Registrant's Address : 2395 Speakman Drive Mississauga, Ontario, Canada L5K 1B3
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2016-02-08
Registration Number : 228MF10118
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2016-06-24
Latest Date of Registration : 2016-06-24
Registration Number : 228MF10062
Registrant's Address : 3 Hua Nanyi Road Chongqing (Changshou) Chemical Industrial Park Chongqing 401254
Initial Date of Registration : 2016-02-24
Latest Date of Registration : 2022-04-13
Registration Number : 227MF10257
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2015-10-21
Latest Date of Registration : 2016-11-15
Registration Number : 228MF10067
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-02-29
Latest Date of Registration : 2018-09-14
Registration Number : 228MF10026
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2016-02-02
Registration Number : 228MF10041
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2019-01-10
Registration Number : 225MF10215
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2013-12-03
Latest Date of Registration : 2016-11-02
Registration Number : 228MF10037
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2022-06-01
Entecavir monohydrate "Yung Shin"
Registration Number : 228MF10066
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2016-02-29
Latest Date of Registration : 2016-02-29
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Entecavir Drug Master File in Japan (Entecavir JDMF) empowers Entecavir API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Entecavir JDMF during the approval evaluation for pharmaceutical products. At the time of Entecavir JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Entecavir suppliers with JDMF on PharmaCompass.
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