01 2AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN
02 1HETERO LABS LIMITED Hyderabad IN
03 2Industriale Chimica S.R.L. Saronno IT
04 1JPN PHARMA PVT LTD Boisar IN
05 1MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN
06 1ZHEJIANG PURE PHARMACEUTICAL CO., LTD. Xianju CN
07 1ZHEJIANG SHENZHOU PHARMACEUTICAL CO., LTD. Taizhou CN
08 1ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Xianju CN
01 8Eplerenone
02 1Eplerenone, Process 2
03 1Eplerenone, Process code - EPLB
01 5China
02 3India
03 2Italy
01 10Valid
Certificate Number : R1-CEP 2015-268 - Rev 00
Status : Valid
Issue Date : 2021-01-06
Type : Chemical
Substance Number : 2765
Eplerenone, Process Code - EPLB
Certificate Number : R0-CEP 2019-028 - Rev 01
Status : Valid
Issue Date : 2020-10-26
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2019-263 - Rev 02
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2024-299 - Rev 00
Status : Valid
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2017-004 - Rev 03
Status : Valid
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2021-373 - Rev 00
Status : Valid
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 2765
Certificate Number : R1-CEP 2015-312 - Rev 02
Status : Valid
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2017-276 - Rev 02
Status : Valid
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 2765
Certificate Number : CEP 2022-244 - Rev 00
Status : Valid
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 2765
Certificate Number : R1-CEP 2015-328 - Rev 00
Status : Valid
Issue Date : 2022-10-05
Type : Chemical
Substance Number : 2765
A Eplerenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eplerenone, including repackagers and relabelers. The FDA regulates Eplerenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eplerenone 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 Eplerenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eplerenone supplier is an individual or a company that provides Eplerenone active pharmaceutical ingredient (API) or Eplerenone finished formulations upon request. The Eplerenone suppliers may include Eplerenone API manufacturers, exporters, distributors and traders.
click here to find a list of Eplerenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eplerenone CEP of the European Pharmacopoeia monograph is often referred to as a Eplerenone Certificate of Suitability (COS). The purpose of a Eplerenone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Eplerenone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Eplerenone to their clients by showing that a Eplerenone CEP has been issued for it. The manufacturer submits a Eplerenone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Eplerenone CEP holder for the record. Additionally, the data presented in the Eplerenone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Eplerenone DMF.
A Eplerenone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Eplerenone 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 Eplerenone suppliers with CEP (COS) on PharmaCompass.
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