01 1Pharmacia & Upjohn SpA Milano IT
01 1Rifabutin
01 1U.S.A
01 1Expired
Certificate Number : R0-CEP 2001-111 - Rev 01
Status : Expired
Issue Date : 2005-03-10
Type : TSE
Substance Number : 1657
A Rifabutin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifabutin, including repackagers and relabelers. The FDA regulates Rifabutin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifabutin 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 Rifabutin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifabutin supplier is an individual or a company that provides Rifabutin active pharmaceutical ingredient (API) or Rifabutin finished formulations upon request. The Rifabutin suppliers may include Rifabutin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifabutin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifabutin CEP of the European Pharmacopoeia monograph is often referred to as a Rifabutin Certificate of Suitability (COS). The purpose of a Rifabutin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifabutin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifabutin to their clients by showing that a Rifabutin CEP has been issued for it. The manufacturer submits a Rifabutin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifabutin CEP holder for the record. Additionally, the data presented in the Rifabutin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifabutin DMF.
A Rifabutin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifabutin 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 Rifabutin suppliers with CEP (COS) on PharmaCompass.
LOOKING FOR A SUPPLIER?