01 2SANDOZ GMBH Kundl AT
01 1Benzylpenicillin (benzathine) tetrahydrate, Sterile, microfine, lecithin/polysorbate coated
02 1Benzylpenicillin (benzathine) tetrahydrate, ‘ FA Process’, sterile, lecithin and polysorbate 80 coated; Material Code Number
01 1Austria
02 1Germany
01 1Valid
02 1Withdrawn 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Status : Withdrawn by Holder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
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PharmaCompass offers a list of Penicillin G Benzathine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Penicillin G Benzathine manufacturer or Penicillin G Benzathine supplier for your needs.
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A Bicillin LA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bicillin LA, including repackagers and relabelers. The FDA regulates Bicillin LA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bicillin LA 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 Bicillin LA supplier is an individual or a company that provides Bicillin LA active pharmaceutical ingredient (API) or Bicillin LA finished formulations upon request. The Bicillin LA suppliers may include Bicillin LA API manufacturers, exporters, distributors and traders.
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A Bicillin LA CEP of the European Pharmacopoeia monograph is often referred to as a Bicillin LA Certificate of Suitability (COS). The purpose of a Bicillin LA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bicillin LA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bicillin LA to their clients by showing that a Bicillin LA CEP has been issued for it. The manufacturer submits a Bicillin LA CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bicillin LA CEP holder for the record. Additionally, the data presented in the Bicillin LA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bicillin LA DMF.
A Bicillin LA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bicillin LA 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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