01 1STERLING S.p.A. Solomeo Di Corciano IT
01 1Flumetasone pivalate
01 1Italy
01 1Valid
Certificate Number : R1-CEP 2010-357 - Rev 00
Status : Valid
Issue Date : 2018-09-05
Type : Chemical
Substance Number : 1327
92
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A Lorinden manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorinden, including repackagers and relabelers. The FDA regulates Lorinden manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorinden 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 Lorinden supplier is an individual or a company that provides Lorinden active pharmaceutical ingredient (API) or Lorinden finished formulations upon request. The Lorinden suppliers may include Lorinden API manufacturers, exporters, distributors and traders.
click here to find a list of Lorinden suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lorinden CEP of the European Pharmacopoeia monograph is often referred to as a Lorinden Certificate of Suitability (COS). The purpose of a Lorinden CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lorinden EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lorinden to their clients by showing that a Lorinden CEP has been issued for it. The manufacturer submits a Lorinden CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lorinden CEP holder for the record. Additionally, the data presented in the Lorinden CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lorinden DMF.
A Lorinden CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lorinden 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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