01 1Reyoung pharmaceutical
02 1Zhejiang Guobang Pharmaceutical
01 2TOPIROXOSTAT
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38983
Submission : 2023-11-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39923
Submission : 2024-05-02
Status : Active
Type : II
A Topiroxostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topiroxostat, including repackagers and relabelers. The FDA regulates Topiroxostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topiroxostat 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 Topiroxostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topiroxostat supplier is an individual or a company that provides Topiroxostat active pharmaceutical ingredient (API) or Topiroxostat finished formulations upon request. The Topiroxostat suppliers may include Topiroxostat API manufacturers, exporters, distributors and traders.
click here to find a list of Topiroxostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topiroxostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Topiroxostat active pharmaceutical ingredient (API) in detail. Different forms of Topiroxostat DMFs exist exist since differing nations have different regulations, such as Topiroxostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topiroxostat DMF submitted to regulatory agencies in the US is known as a USDMF. Topiroxostat USDMF includes data on Topiroxostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topiroxostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topiroxostat suppliers with USDMF on PharmaCompass.
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