01 1OLON S.P.A. Rodano IT
01 1Cyproheptadine hydrochloride 1.5-hydrate
01 1Italy
01 1Valid
Cyproheptadine Hydrochloride 1.5-hydrate
Certificate Number : CEP 2014-049 - Rev 02
Status : Valid
Issue Date : 2025-02-05
Type : Chemical
Substance Number : 817
87
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A Cipractin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cipractin, including repackagers and relabelers. The FDA regulates Cipractin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cipractin 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 Cipractin supplier is an individual or a company that provides Cipractin active pharmaceutical ingredient (API) or Cipractin finished formulations upon request. The Cipractin suppliers may include Cipractin API manufacturers, exporters, distributors and traders.
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A Cipractin CEP of the European Pharmacopoeia monograph is often referred to as a Cipractin Certificate of Suitability (COS). The purpose of a Cipractin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cipractin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cipractin to their clients by showing that a Cipractin CEP has been issued for it. The manufacturer submits a Cipractin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cipractin CEP holder for the record. Additionally, the data presented in the Cipractin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cipractin DMF.
A Cipractin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cipractin 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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