01 1HETERO LABS LIMITED Hyderabad IN
02 1MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN
03 1SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN
01 2Sorafenib tosilate, Form-III
02 1Sorafenib tosilate, Micronised, polymorphic form I
01 1China
02 2India
01 3Valid
Certificate Number : CEP 2021-324 - Rev 01
Status : Valid
Issue Date : 2024-11-25
Type : Chemical
Substance Number : 2931
Certificate Number : CEP 2021-430 - Rev 01
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 2931
Sorafenib Tosilate, Micronised, Polymorphic Form...
Certificate Number : CEP 2023-250 - Rev 01
Status : Valid
Issue Date : 2023-12-20
Type : Chemical
Substance Number : 2931
A Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexavar, including repackagers and relabelers. The FDA regulates Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexavar 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 Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexavar supplier is an individual or a company that provides Nexavar active pharmaceutical ingredient (API) or Nexavar finished formulations upon request. The Nexavar suppliers may include Nexavar API manufacturers, exporters, distributors and traders.
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A Nexavar CEP of the European Pharmacopoeia monograph is often referred to as a Nexavar Certificate of Suitability (COS). The purpose of a Nexavar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexavar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexavar to their clients by showing that a Nexavar CEP has been issued for it. The manufacturer submits a Nexavar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexavar CEP holder for the record. Additionally, the data presented in the Nexavar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexavar DMF.
A Nexavar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexavar CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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