01 1PETER GREVEN NEDERLAND C.V. Venlo NL
02 1PMC BIOGENIX, INC. Memphis US
03 1SO.G.I.S Industria Chimica SpA Sospiro IT
01 3Magnesium stearate
01 1Italy
02 1Netherlands
03 1U.S.A
01 3Valid
Certificate Number : CEP 2021-296 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 229
Certificate Number : R1-CEP 2001-005 - Rev 01
Status : Valid
Issue Date : 2008-05-16
Type : TSE
Substance Number : 229
Certificate Number : R1-CEP 2001-039 - Rev 00
Status : Valid
Issue Date : 2006-11-02
Type : Chemical and TSE
Substance Number : 229
92
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A Synpro 90 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Synpro 90, including repackagers and relabelers. The FDA regulates Synpro 90 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Synpro 90 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Synpro 90 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Synpro 90 supplier is an individual or a company that provides Synpro 90 active pharmaceutical ingredient (API) or Synpro 90 finished formulations upon request. The Synpro 90 suppliers may include Synpro 90 API manufacturers, exporters, distributors and traders.
click here to find a list of Synpro 90 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Synpro 90 CEP of the European Pharmacopoeia monograph is often referred to as a Synpro 90 Certificate of Suitability (COS). The purpose of a Synpro 90 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Synpro 90 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Synpro 90 to their clients by showing that a Synpro 90 CEP has been issued for it. The manufacturer submits a Synpro 90 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Synpro 90 CEP holder for the record. Additionally, the data presented in the Synpro 90 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Synpro 90 DMF.
A Synpro 90 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Synpro 90 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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