01 1Jiangsu Hengrui Medicine
01 1RIVOCERANIB MESYLATE, NON-STERILE, BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37320
Submission : 2023-01-20
Status : Active
Type : II
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PharmaCompass offers a list of Apatinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Apatinib manufacturer or Apatinib supplier for your needs.
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A Apatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apatinib, including repackagers and relabelers. The FDA regulates Apatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apatinib 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 Apatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Apatinib supplier is an individual or a company that provides Apatinib active pharmaceutical ingredient (API) or Apatinib finished formulations upon request. The Apatinib suppliers may include Apatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Apatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Apatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Apatinib active pharmaceutical ingredient (API) in detail. Different forms of Apatinib DMFs exist exist since differing nations have different regulations, such as Apatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Apatinib USDMF includes data on Apatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
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