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01 1EUROAPI HUNGARY Ltd. Budapest HU
02 1EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION Taipei TW
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01 2Alprostadil
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01 1France
02 1Taiwan
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01 2Valid
Certificate Number : R1-CEP 2015-302 - Rev 00
Status : Valid
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1488
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Certificate Number : CEP 2012-204 - Rev 02
Status : Valid
Issue Date : 2025-10-28
Type : Chemical
Substance Number : 1488

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A (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid, including repackagers and relabelers. The FDA regulates (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid supplier is an individual or a company that provides (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid active pharmaceutical ingredient (API) or (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid finished formulations upon request. The (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid suppliers may include (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid API manufacturers, exporters, distributors and traders.
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A (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP of the European Pharmacopoeia monograph is often referred to as a (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid Certificate of Suitability (COS). The purpose of a (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid to their clients by showing that a (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP has been issued for it. The manufacturer submits a (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP holder for the record. Additionally, the data presented in the (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid DMF.
A (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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We have 2 companies offering (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid
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