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
A Rivoceranib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rivoceranib, including repackagers and relabelers. The FDA regulates Rivoceranib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rivoceranib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Rivoceranib supplier is an individual or a company that provides Rivoceranib active pharmaceutical ingredient (API) or Rivoceranib finished formulations upon request. The Rivoceranib suppliers may include Rivoceranib API manufacturers, exporters, distributors and traders.
click here to find a list of Rivoceranib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rivoceranib DMF (Drug Master File) is a document detailing the whole manufacturing process of Rivoceranib active pharmaceutical ingredient (API) in detail. Different forms of Rivoceranib DMFs exist exist since differing nations have different regulations, such as Rivoceranib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rivoceranib DMF submitted to regulatory agencies in the US is known as a USDMF. Rivoceranib USDMF includes data on Rivoceranib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rivoceranib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rivoceranib suppliers with USDMF on PharmaCompass.
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