01 2APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
02 1CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL
03 2FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT
04 1Istituto Biochimico Italiano "G. Lorenzini" S.p.A. Aprilia IT
05 1KDL Biotech Limited Mumbai IN
06 1PARABOLIC DRUGS LIMITED Panchkula District IN
07 1SANDOZ INDUSTRIAL PRODUCTS S.A. Les Franqueses Del Vallès ES
08 1Sandoz Industrial Products S.A. Les Franqueses Del Vallès ES
01 4Cloxacillin sodium
02 1Cloxacillin sodium, Powder and compacted
03 1Cloxacillin sodium, Powder, Compacted
04 3Cloxacillin sodium, Sterile
05 1Cloxacillin sodium, Sterile, Crystalline
01 2Germany
02 4India
03 2Italy
04 1Netherlands
05 1Sweden
01 6Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
Certificate Number : CEP 2008-250 - Rev 06
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 661
Certificate Number : CEP 2019-277 - Rev 02
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 661
Certificate Number : R1-CEP 2003-207 - Rev 07
Status : Valid
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 661
Certificate Number : R1-CEP 1998-025 - Rev 08
Status : Valid
Issue Date : 2021-06-10
Type : Chemical
Substance Number : 661
Cloxacillin Sodium, Powder And Compacted
Certificate Number : R1-CEP 1996-091 - Rev 08
Status : Valid
Issue Date : 2021-02-10
Type : Chemical
Substance Number : 661
Cloxacillin Sodium, Sterile, Crystalline
Certificate Number : R1-CEP 2001-241 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2009-10-16
Type : Chemical
Substance Number : 661
Certificate Number : R0-CEP 1997-131 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2004-11-17
Type : Chemical
Substance Number : 661
Certificate Number : R0-CEP 2010-350 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2013-07-04
Type : Chemical
Substance Number : 661
Cloxacillin Sodium, Powder, Compacted
Certificate Number : R2-CEP 1995-036 - Rev 05
Status : Valid
Issue Date : 2019-11-18
Type : Chemical
Substance Number : 661
Certificate Number : R1-CEP 2001-233 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2013-11-29
Type : Chemical
Substance Number : 661
29
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A Orbenin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orbenin, including repackagers and relabelers. The FDA regulates Orbenin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orbenin 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 Orbenin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Orbenin supplier is an individual or a company that provides Orbenin active pharmaceutical ingredient (API) or Orbenin finished formulations upon request. The Orbenin suppliers may include Orbenin API manufacturers, exporters, distributors and traders.
click here to find a list of Orbenin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Orbenin CEP of the European Pharmacopoeia monograph is often referred to as a Orbenin Certificate of Suitability (COS). The purpose of a Orbenin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orbenin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orbenin to their clients by showing that a Orbenin CEP has been issued for it. The manufacturer submits a Orbenin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orbenin CEP holder for the record. Additionally, the data presented in the Orbenin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orbenin DMF.
A Orbenin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orbenin 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 Orbenin suppliers with CEP (COS) on PharmaCompass.
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