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