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
PharmaCompass offers a list of MAPROTILINE HYDROCHLORIDE API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right MAPROTILINE HYDROCHLORIDE manufacturer or MAPROTILINE HYDROCHLORIDE supplier for your needs.
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A Mirpan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirpan, including repackagers and relabelers. The FDA regulates Mirpan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirpan 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 Mirpan supplier is an individual or a company that provides Mirpan active pharmaceutical ingredient (API) or Mirpan finished formulations upon request. The Mirpan suppliers may include Mirpan API manufacturers, exporters, distributors and traders.
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A Mirpan CEP of the European Pharmacopoeia monograph is often referred to as a Mirpan Certificate of Suitability (COS). The purpose of a Mirpan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirpan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirpan to their clients by showing that a Mirpan CEP has been issued for it. The manufacturer submits a Mirpan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirpan CEP holder for the record. Additionally, the data presented in the Mirpan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirpan DMF.
A Mirpan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirpan 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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