01 1Chemische Fabrik Berg GmbH Bitterfeld-Wolfen DE
02 1ALKALOIDA CHEMICAL COMPANY ZRT. Tiszavasvari HU
03 1HARMAN FINOCHEM LIMITED Mumbai IN
04 1JPN PHARMA PVT LTD Boisar IN
05 1NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN
06 1SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN
01 6Phenobarbital
01 2China
02 1Germany
03 1Hungary
04 2India
01 6Valid
Certificate Number : CEP 2022-432 - Rev 00
Status : Valid
Issue Date : 2023-11-09
Type : Chemical
Substance Number : 201
Certificate Number : R1-CEP 2009-132 - Rev 03
Status : Valid
Issue Date : 2021-12-08
Type : Chemical
Substance Number : 201
Certificate Number : CEP 2003-017 - Rev 04
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 201
Certificate Number : CEP 2022-306 - Rev 00
Status : Valid
Issue Date : 2024-07-24
Type : Chemical
Substance Number : 201
Certificate Number : R1-CEP 2005-118 - Rev 02
Status : Valid
Issue Date : 2016-10-04
Type : Chemical
Substance Number : 201
Certificate Number : CEP 2017-269 - Rev 01
Status : Valid
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 201
A Phenobarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenobarbital, including repackagers and relabelers. The FDA regulates Phenobarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenobarbital 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 Phenobarbital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenobarbital supplier is an individual or a company that provides Phenobarbital active pharmaceutical ingredient (API) or Phenobarbital finished formulations upon request. The Phenobarbital suppliers may include Phenobarbital API manufacturers, exporters, distributors and traders.
click here to find a list of Phenobarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenobarbital CEP of the European Pharmacopoeia monograph is often referred to as a Phenobarbital Certificate of Suitability (COS). The purpose of a Phenobarbital CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenobarbital EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenobarbital to their clients by showing that a Phenobarbital CEP has been issued for it. The manufacturer submits a Phenobarbital CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenobarbital CEP holder for the record. Additionally, the data presented in the Phenobarbital CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenobarbital DMF.
A Phenobarbital CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenobarbital 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 Phenobarbital suppliers with CEP (COS) on PharmaCompass.
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