01 1OLON S.P.A. Rodano IT
01 1Maprotiline hydrochloride
01 1Italy
01 1Valid
Certificate Number : CEP 2006-290 - Rev 09
Status : Valid
Issue Date : 2025-03-06
Type : Chemical
Substance Number : 1237
59
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A Deprilept manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deprilept, including repackagers and relabelers. The FDA regulates Deprilept manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deprilept 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 Deprilept supplier is an individual or a company that provides Deprilept active pharmaceutical ingredient (API) or Deprilept finished formulations upon request. The Deprilept suppliers may include Deprilept API manufacturers, exporters, distributors and traders.
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A Deprilept CEP of the European Pharmacopoeia monograph is often referred to as a Deprilept Certificate of Suitability (COS). The purpose of a Deprilept CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deprilept EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deprilept to their clients by showing that a Deprilept CEP has been issued for it. The manufacturer submits a Deprilept CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deprilept CEP holder for the record. Additionally, the data presented in the Deprilept CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deprilept DMF.
A Deprilept CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deprilept 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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