01 1QUALIX DOT S.L. L’Hospitalet de Llobregat ES
01 1Etidronate disodium
01 1Blank
01 1Valid
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Certificate Number : CEP 2023-321 - Rev 00
Status : Valid
Issue Date : 2025-01-31
Type : Chemical
Substance Number : 1778
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A Turpinal 2NZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Turpinal 2NZ, including repackagers and relabelers. The FDA regulates Turpinal 2NZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Turpinal 2NZ 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 Turpinal 2NZ supplier is an individual or a company that provides Turpinal 2NZ active pharmaceutical ingredient (API) or Turpinal 2NZ finished formulations upon request. The Turpinal 2NZ suppliers may include Turpinal 2NZ API manufacturers, exporters, distributors and traders.
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A Turpinal 2NZ CEP of the European Pharmacopoeia monograph is often referred to as a Turpinal 2NZ Certificate of Suitability (COS). The purpose of a Turpinal 2NZ CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Turpinal 2NZ EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Turpinal 2NZ to their clients by showing that a Turpinal 2NZ CEP has been issued for it. The manufacturer submits a Turpinal 2NZ CEP (COS) as part of the market authorization procedure, and it takes on the role of a Turpinal 2NZ CEP holder for the record. Additionally, the data presented in the Turpinal 2NZ CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Turpinal 2NZ DMF.
A Turpinal 2NZ CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Turpinal 2NZ 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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