01 1ACS DOBFAR S.P.A. Tribiano IT
02 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
03 1CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL
04 1ORCHID PHARMA LIMITED Alathur IN
05 1Ranbaxy Laboratories Limited New Delhi IN
01 3Cefadroxil monohydrate
02 1Cefadroxil monohydrate, Enzymatic process
03 1Cefadroxil monohydrate, Powder, compacted
01 3India
02 1Italy
03 1Netherlands
01 3Valid
02 2Withdrawn by Holder
Cefadroxil Monohydrate, Powder, Compacted
Certificate Number : R1-CEP 1999-174 - Rev 04
Status : Valid
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 813
Certificate Number : CEP 2006-203 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 813
Cefadroxil Monohydrate, Enzymatic Process
Certificate Number : CEP 2002-156 - Rev 06
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 813
Certificate Number : CEP 2002-234 - Rev 03
Status : Valid
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 813
Certificate Number : R1-CEP 1998-019 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2003-12-18
Type : Chemical
Substance Number : 813
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PharmaCompass offers a list of Cefadroxil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cefadroxil manufacturer or Cefadroxil supplier for your needs.
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A Oracefal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oracefal, including repackagers and relabelers. The FDA regulates Oracefal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oracefal 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 Oracefal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Oracefal supplier is an individual or a company that provides Oracefal active pharmaceutical ingredient (API) or Oracefal finished formulations upon request. The Oracefal suppliers may include Oracefal API manufacturers, exporters, distributors and traders.
click here to find a list of Oracefal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Oracefal CEP of the European Pharmacopoeia monograph is often referred to as a Oracefal Certificate of Suitability (COS). The purpose of a Oracefal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oracefal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oracefal to their clients by showing that a Oracefal CEP has been issued for it. The manufacturer submits a Oracefal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oracefal CEP holder for the record. Additionally, the data presented in the Oracefal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oracefal DMF.
A Oracefal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oracefal 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 Oracefal suppliers with CEP (COS) on PharmaCompass.
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