01 1Becton, Dickinson and Company Sparks US
01 1Lactose Broth, Codes 241000, 242000, 243000, 211835
01 1U.S.A
01 1Valid
Lactose Broth, Codes 241000, 242000, 243000, 211...
Certificate Number : R1-CEP 2000-371 - Rev 04
Status : Valid
Issue Date : 2013-09-03
Type : TSE
Substance Number :
A Lactose API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactose API, including repackagers and relabelers. The FDA regulates Lactose API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactose API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lactose API supplier is an individual or a company that provides Lactose API active pharmaceutical ingredient (API) or Lactose API finished formulations upon request. The Lactose API suppliers may include Lactose API API manufacturers, exporters, distributors and traders.
click here to find a list of Lactose API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactose API CEP of the European Pharmacopoeia monograph is often referred to as a Lactose API Certificate of Suitability (COS). The purpose of a Lactose API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lactose API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lactose API to their clients by showing that a Lactose API CEP has been issued for it. The manufacturer submits a Lactose API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lactose API CEP holder for the record. Additionally, the data presented in the Lactose API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lactose API DMF.
A Lactose API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lactose API 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 Lactose API suppliers with CEP (COS) on PharmaCompass.
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