01 1Alivira Animal Health
02 1Azico Biophore India Pvt. Ltd
01 2TRICLABENDAZOLE
01 2India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31790
Submission : 2018-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37483
Submission : 2022-10-31
Status : Active
Type : II
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A Fasinex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasinex, including repackagers and relabelers. The FDA regulates Fasinex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasinex 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 Fasinex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fasinex supplier is an individual or a company that provides Fasinex active pharmaceutical ingredient (API) or Fasinex finished formulations upon request. The Fasinex suppliers may include Fasinex API manufacturers, exporters, distributors and traders.
click here to find a list of Fasinex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fasinex DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasinex active pharmaceutical ingredient (API) in detail. Different forms of Fasinex DMFs exist exist since differing nations have different regulations, such as Fasinex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasinex DMF submitted to regulatory agencies in the US is known as a USDMF. Fasinex USDMF includes data on Fasinex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasinex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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