01 2APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
01 1Oxacillin sodium monohydrate
02 1Oxacillin sodium monohydrate, Sterile
01 2India
01 2Valid
Certificate Number : CEP 2007-349 - Rev 06
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 2260
Oxacillin Sodium Monohydrate, Sterile
Certificate Number : CEP 2007-363 - Rev 04
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 2260
98
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A O0353 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of O0353, including repackagers and relabelers. The FDA regulates O0353 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. O0353 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 O0353 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A O0353 supplier is an individual or a company that provides O0353 active pharmaceutical ingredient (API) or O0353 finished formulations upon request. The O0353 suppliers may include O0353 API manufacturers, exporters, distributors and traders.
click here to find a list of O0353 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A O0353 CEP of the European Pharmacopoeia monograph is often referred to as a O0353 Certificate of Suitability (COS). The purpose of a O0353 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of O0353 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of O0353 to their clients by showing that a O0353 CEP has been issued for it. The manufacturer submits a O0353 CEP (COS) as part of the market authorization procedure, and it takes on the role of a O0353 CEP holder for the record. Additionally, the data presented in the O0353 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the O0353 DMF.
A O0353 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. O0353 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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