01 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
02 1ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN
01 2Cilastatin sodium, Sterile
01 1China
02 1India
01 1Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2009-179 - Rev 02
Status : Valid
Issue Date : 2022-02-21
Type : Chemical
Substance Number : 1408
Certificate Number : R1-CEP 2010-184 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-10-26
Type : Chemical
Substance Number : 1408
A Cilastatin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilastatin Sodium, including repackagers and relabelers. The FDA regulates Cilastatin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilastatin Sodium 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 Cilastatin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilastatin Sodium supplier is an individual or a company that provides Cilastatin Sodium active pharmaceutical ingredient (API) or Cilastatin Sodium finished formulations upon request. The Cilastatin Sodium suppliers may include Cilastatin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Cilastatin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cilastatin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Cilastatin Sodium Certificate of Suitability (COS). The purpose of a Cilastatin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cilastatin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cilastatin Sodium to their clients by showing that a Cilastatin Sodium CEP has been issued for it. The manufacturer submits a Cilastatin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cilastatin Sodium CEP holder for the record. Additionally, the data presented in the Cilastatin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cilastatin Sodium DMF.
A Cilastatin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cilastatin Sodium 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 Cilastatin Sodium suppliers with CEP (COS) on PharmaCompass.
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