01 1C-SQUARED PHARMA LIMITED Cork IE
02 1FARMAK JSC Kyiv UA
03 1LOBA BIOTECH GMBH Fischamend AT
01 3Naphazoline nitrate
01 1Austria
02 1Ireland
03 1Ukraine
01 3Valid
Certificate Number : CEP 2025-360 - Rev 00
Status : Valid
Issue Date : 2026-04-22
Type : Chemical
Substance Number : 147
Certificate Number : CEP 2025-137 - Rev 00
Status : Valid
Issue Date : 2025-09-16
Type : Chemical
Substance Number : 147
Certificate Number : CEP 2023-091 - Rev 00
Status : Valid
Issue Date : 2024-06-14
Type : Chemical
Substance Number : 147
22
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A AKCon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AKCon, including repackagers and relabelers. The FDA regulates AKCon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AKCon 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 AKCon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A AKCon supplier is an individual or a company that provides AKCon active pharmaceutical ingredient (API) or AKCon finished formulations upon request. The AKCon suppliers may include AKCon API manufacturers, exporters, distributors and traders.
click here to find a list of AKCon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AKCon CEP of the European Pharmacopoeia monograph is often referred to as a AKCon Certificate of Suitability (COS). The purpose of a AKCon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AKCon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AKCon to their clients by showing that a AKCon CEP has been issued for it. The manufacturer submits a AKCon CEP (COS) as part of the market authorization procedure, and it takes on the role of a AKCon CEP holder for the record. Additionally, the data presented in the AKCon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AKCon DMF.
A AKCon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AKCon 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 AKCon suppliers with CEP (COS) on PharmaCompass.
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