Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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01 1CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL
02 1ACS DOBFAR S.P.A. Tribiano IT
03 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
04 1ORCHID PHARMA LIMITED Alathur IN
05 1Ranbaxy Laboratories Limited New Delhi IN
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01 3Cefadroxil monohydrate
02 1Cefadroxil monohydrate, Enzymatic process
03 1Cefadroxil monohydrate, Powder, compacted
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01 3India
02 1Italy
03 1Netherlands
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01 3Valid
02 2Withdrawn by Holder
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Cefadroxil Monohydrate, Enzymatic Process
Certificate Number : CEP 2002-156 - Rev 06
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 813
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Cefadroxil Monohydrate, Powder, Compacted
Certificate Number : R1-CEP 1999-174 - Rev 04
Status : Valid
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 813

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Certificate Number : CEP 2006-203 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 813

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Certificate Number : CEP 2002-234 - Rev 03
Status : Valid
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 813

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Status : Withdrawn by Holder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