01 1DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
02 1UMICORE ARGENTINA S.A. Pilar Industrial Park AR
01 2Lomustine
01 1Gabon
02 1Germany
01 2Valid
Certificate Number : R0-CEP 2021-132 - Rev 00
Status : Valid
Issue Date : 2022-11-10
Type : Chemical
Substance Number : 928
Certificate Number : CEP 2009-141 - Rev 03
Status : Valid
Issue Date : 2024-08-16
Type : Chemical
Substance Number : 928
A Lomustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomustine, including repackagers and relabelers. The FDA regulates Lomustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomustine 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 Lomustine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomustine supplier is an individual or a company that provides Lomustine active pharmaceutical ingredient (API) or Lomustine finished formulations upon request. The Lomustine suppliers may include Lomustine API manufacturers, exporters, distributors and traders.
click here to find a list of Lomustine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomustine CEP of the European Pharmacopoeia monograph is often referred to as a Lomustine Certificate of Suitability (COS). The purpose of a Lomustine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lomustine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lomustine to their clients by showing that a Lomustine CEP has been issued for it. The manufacturer submits a Lomustine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lomustine CEP holder for the record. Additionally, the data presented in the Lomustine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lomustine DMF.
A Lomustine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lomustine 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 Lomustine suppliers with CEP (COS) on PharmaCompass.
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