01 1MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN
02 1RAVI BIOLIFE PRIVATE LTD. Mumbai IN
03 1SHANDONG LIXIN PHARMACEUTICAL CO. LTD. Zibo CN
01 3Nilotinib hydrochloride monohydrate
01 1China
02 1India
03 1Blank
01 3Valid
Nilotinib Hydrochloride Monohydrate
Certificate Number : R0-CEP 2020-176 - Rev 00
Status : Valid
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 2993
Nilotinib Hydrochloride Monohydrate
Certificate Number : R0-CEP 2021-133 - Rev 00
Status : Valid
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 2993
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Nilotinib Hydrochloride Monohydrate
Certificate Number : CEP 2022-425 - Rev 00
Status : Valid
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 2993
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Product Web Link
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A Nilotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilotinib, including repackagers and relabelers. The FDA regulates Nilotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilotinib 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 Nilotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilotinib supplier is an individual or a company that provides Nilotinib active pharmaceutical ingredient (API) or Nilotinib finished formulations upon request. The Nilotinib suppliers may include Nilotinib API manufacturers, exporters, distributors and traders.
click here to find a list of Nilotinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilotinib CEP of the European Pharmacopoeia monograph is often referred to as a Nilotinib Certificate of Suitability (COS). The purpose of a Nilotinib CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilotinib EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilotinib to their clients by showing that a Nilotinib CEP has been issued for it. The manufacturer submits a Nilotinib CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilotinib CEP holder for the record. Additionally, the data presented in the Nilotinib CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilotinib DMF.
A Nilotinib CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilotinib 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 Nilotinib suppliers with CEP (COS) on PharmaCompass.
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