01 1ANHUI BIOCHEM PHARMACEUTICAL CO., LTD. Fuyang CN
02 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
03 1BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. Suzhou CN
04 1CIPLA LIMITED Mumbai IN
05 1DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR
06 1HETERO DRUGS LIMITED Hyderabad IN
07 1SCINOPHARM TAIWAN, LTD. Shan-Hua TW
08 1Wisdom Pharmaceutical Co., Ltd. Haimen CN
09 1ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN
01 9Entecavir monohydrate
01 4China
02 3India
03 1South Korea
04 1Taiwan
01 9Valid
Certificate Number : CEP 2021-083 - Rev 01
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-043 - Rev 01
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-283 - Rev 01
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-051 - Rev 00
Status : Valid
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 2815
Certificate Number : R0-CEP 2018-093 - Rev 00
Status : Valid
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-271 - Rev 04
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-001 - Rev 01
Status : Valid
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-006 - Rev 01
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-152 - Rev 00
Status : Valid
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2815
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.
A Entecavir CEP of the European Pharmacopoeia monograph is often referred to as a Entecavir Certificate of Suitability (COS). The purpose of a Entecavir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Entecavir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Entecavir to their clients by showing that a Entecavir CEP has been issued for it. The manufacturer submits a Entecavir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Entecavir CEP holder for the record. Additionally, the data presented in the Entecavir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Entecavir DMF.
A Entecavir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Entecavir CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Entecavir suppliers with CEP (COS) on PharmaCompass.
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