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Status : Withdrawn by Holder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Status : Withdrawn by Holder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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A Ultracef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultracef, including repackagers and relabelers. The FDA regulates Ultracef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultracef 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 Ultracef manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ultracef supplier is an individual or a company that provides Ultracef active pharmaceutical ingredient (API) or Ultracef finished formulations upon request. The Ultracef suppliers may include Ultracef API manufacturers, exporters, distributors and traders.
click here to find a list of Ultracef suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ultracef CEP of the European Pharmacopoeia monograph is often referred to as a Ultracef Certificate of Suitability (COS). The purpose of a Ultracef CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ultracef EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ultracef to their clients by showing that a Ultracef CEP has been issued for it. The manufacturer submits a Ultracef CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ultracef CEP holder for the record. Additionally, the data presented in the Ultracef CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ultracef DMF.
A Ultracef CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ultracef 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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