01 1GALACTIC S.A. Escanaffles BE
02 1Purac Biochem BV Gorinchem NL
03 1Roquette Frères Lestrem FR
01 2Sodium (S)-lactate solution
02 1Sodium (S)-lactate solution, 50%, 60% sodium lactate content
01 1Belgium
02 1France
03 1Netherlands
01 1Valid
02 2Withdrawn by Holder
Certificate Number : R1-CEP 1999-038 - Rev 01
Status : Valid
Issue Date : 2014-10-06
Type : Chemical
Substance Number : 2033
Sodium (S)-lactate Solution, 50%, 60% Sodium La...
Certificate Number : R0-CEP 2015-372 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-11-17
Type : Chemical
Substance Number : 2033
Certificate Number : R0-CEP 2006-048 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2007-06-08
Type : Chemical
Substance Number : 2033
100
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4, including repackagers and relabelers. The FDA regulates DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 supplier is an individual or a company that provides DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 active pharmaceutical ingredient (API) or DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 finished formulations upon request. The DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 suppliers may include DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 API manufacturers, exporters, distributors and traders.
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP of the European Pharmacopoeia monograph is often referred to as a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 Certificate of Suitability (COS). The purpose of a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 to their clients by showing that a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP has been issued for it. The manufacturer submits a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP holder for the record. Additionally, the data presented in the DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 DMF.
A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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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