01 1Fujifilm Diosynth Biotechnologies
01 1MIANSERIN HYDROCHLORIDE
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5945
Submission : 1985-08-05
Status : Inactive
Type : II
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A Tolvon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolvon, including repackagers and relabelers. The FDA regulates Tolvon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolvon 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 Tolvon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tolvon supplier is an individual or a company that provides Tolvon active pharmaceutical ingredient (API) or Tolvon finished formulations upon request. The Tolvon suppliers may include Tolvon API manufacturers, exporters, distributors and traders.
click here to find a list of Tolvon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tolvon DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolvon active pharmaceutical ingredient (API) in detail. Different forms of Tolvon DMFs exist exist since differing nations have different regulations, such as Tolvon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolvon DMF submitted to regulatory agencies in the US is known as a USDMF. Tolvon USDMF includes data on Tolvon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolvon USDMF is kept confidential to protect the manufacturer’s intellectual property.
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