01 1Synthon Pharmaceuticals
01 1TIVOZANIB HYDROCHLORIDE MONOHYDRATE
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-09
Pay. Date : 2024-09-09
DMF Number : 40289
Submission : 2024-09-10
Status : Active
Type : II
A Tivozanib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tivozanib, including repackagers and relabelers. The FDA regulates Tivozanib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tivozanib 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 Tivozanib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tivozanib supplier is an individual or a company that provides Tivozanib active pharmaceutical ingredient (API) or Tivozanib finished formulations upon request. The Tivozanib suppliers may include Tivozanib API manufacturers, exporters, distributors and traders.
click here to find a list of Tivozanib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tivozanib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tivozanib active pharmaceutical ingredient (API) in detail. Different forms of Tivozanib DMFs exist exist since differing nations have different regulations, such as Tivozanib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tivozanib DMF submitted to regulatory agencies in the US is known as a USDMF. Tivozanib USDMF includes data on Tivozanib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tivozanib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tivozanib suppliers with USDMF on PharmaCompass.
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