01 1BCN PEPTIDES S.A. St Quinti De Mediona ES
02 1PIRAMAL PHARMA LIMITED Mumbai IN
01 2Buserelin
01 1Spain
02 1U.S.A
01 2Valid
Certificate Number : R1-CEP 2007-034 - Rev 02
Status : Valid
Issue Date : 2015-12-21
Type : Chemical
Substance Number : 1077
Certificate Number : R1-CEP 2013-308 - Rev 01
Status : Valid
Issue Date : 2022-10-04
Type : Chemical
Substance Number : 1077
A Buserelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buserelin, including repackagers and relabelers. The FDA regulates Buserelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buserelin 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 Buserelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Buserelin supplier is an individual or a company that provides Buserelin active pharmaceutical ingredient (API) or Buserelin finished formulations upon request. The Buserelin suppliers may include Buserelin API manufacturers, exporters, distributors and traders.
click here to find a list of Buserelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Buserelin CEP of the European Pharmacopoeia monograph is often referred to as a Buserelin Certificate of Suitability (COS). The purpose of a Buserelin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buserelin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buserelin to their clients by showing that a Buserelin CEP has been issued for it. The manufacturer submits a Buserelin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buserelin CEP holder for the record. Additionally, the data presented in the Buserelin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buserelin DMF.
A Buserelin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buserelin 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 Buserelin suppliers with CEP (COS) on PharmaCompass.
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