01 1CONCORD BIOTECH LIMITED Ahmedabad IN
01 1Mycophenolate mofetil, By azeotropic distillation
01 1India
01 1Valid
Mycophenolate Mofetil, By Azeotropic Distillatio...
Certificate Number : CEP 2018-157 - Rev 02
Status : Valid
Issue Date : 2024-02-09
Type : Chemical
Substance Number : 1700
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A 483-60-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 483-60-3, including repackagers and relabelers. The FDA regulates 483-60-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 483-60-3 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 483-60-3 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 483-60-3 supplier is an individual or a company that provides 483-60-3 active pharmaceutical ingredient (API) or 483-60-3 finished formulations upon request. The 483-60-3 suppliers may include 483-60-3 API manufacturers, exporters, distributors and traders.
click here to find a list of 483-60-3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 483-60-3 CEP of the European Pharmacopoeia monograph is often referred to as a 483-60-3 Certificate of Suitability (COS). The purpose of a 483-60-3 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 483-60-3 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 483-60-3 to their clients by showing that a 483-60-3 CEP has been issued for it. The manufacturer submits a 483-60-3 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 483-60-3 CEP holder for the record. Additionally, the data presented in the 483-60-3 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 483-60-3 DMF.
A 483-60-3 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 483-60-3 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of 483-60-3 suppliers with CEP (COS) on PharmaCompass.
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