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01 1EUROAPI HUNGARY Ltd. Budapest HU
02 1EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION Taipei TW
01 2Alprostadil
01 1France
02 1Taiwan
01 2Valid
Certificate Number : R1-CEP 2015-302 - Rev 00
Status : Valid
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1488
Certificate Number : R1-CEP 2012-204 - Rev 01
Status : Valid
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 1488
A Alprostadil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil, including repackagers and relabelers. The FDA regulates Alprostadil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil 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 Alprostadil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil supplier is an individual or a company that provides Alprostadil active pharmaceutical ingredient (API) or Alprostadil finished formulations upon request. The Alprostadil suppliers may include Alprostadil API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil CEP of the European Pharmacopoeia monograph is often referred to as a Alprostadil Certificate of Suitability (COS). The purpose of a Alprostadil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alprostadil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alprostadil to their clients by showing that a Alprostadil CEP has been issued for it. The manufacturer submits a Alprostadil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alprostadil CEP holder for the record. Additionally, the data presented in the Alprostadil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alprostadil DMF.
A Alprostadil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alprostadil 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 Alprostadil suppliers with CEP (COS) on PharmaCompass.
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