01 2SANDOZ GMBH Kundl AT
02 1SANDOZ INDUSTRIAL PRODUCTS GMBH Frankfurt Am Main DE
01 1Benzylpenicillin (benzathine) tetrahydrate, Lecithin and Polysorbate 80 coated, Sterile
02 1Benzylpenicillin (benzathine) tetrahydrate, Sterile, microfine, lecithin/polysorbate coated
03 1Benzylpenicillin (benzathine) tetrahydrate, ‘ FA Process’, sterile, lecithin and polysorbate 80 coated; Material Code Number
01 1Austria
02 1Gambia
03 1Germany
01 1Valid
02 2Withdrawn by Holder
Benzylpenicillin (benzathine) Tetrahydrate, Ster...
Certificate Number : R1-CEP 2001-066 - Rev 05
Status : Valid
Issue Date : 2023-07-26
Type : Chemical
Substance Number : 373
Benzylpenicillin (benzathine) Tetrahydrate, ‘ ...
Certificate Number : R1-CEP 1994-018 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2004-12-01
Type : Chemical
Substance Number : 373
Benzylpenicillin (benzathine) Tetrahydrate, Leci...
Certificate Number : R1-CEP 2002-111 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2009-10-22
Type : Chemical
Substance Number : 373
10
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A Benzetacil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzetacil, including repackagers and relabelers. The FDA regulates Benzetacil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzetacil 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 Benzetacil supplier is an individual or a company that provides Benzetacil active pharmaceutical ingredient (API) or Benzetacil finished formulations upon request. The Benzetacil suppliers may include Benzetacil API manufacturers, exporters, distributors and traders.
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A Benzetacil CEP of the European Pharmacopoeia monograph is often referred to as a Benzetacil Certificate of Suitability (COS). The purpose of a Benzetacil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benzetacil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benzetacil to their clients by showing that a Benzetacil CEP has been issued for it. The manufacturer submits a Benzetacil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benzetacil CEP holder for the record. Additionally, the data presented in the Benzetacil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benzetacil DMF.
A Benzetacil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzetacil 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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