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Status : Withdrawn by Holder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Status : Withdrawn by Holder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