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