01 1Elanco
01 1DICLAZURIL
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8218
Submission : 1989-08-18
Status : Active
Type : II
A Diclazuril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diclazuril, including repackagers and relabelers. The FDA regulates Diclazuril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diclazuril 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 Diclazuril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diclazuril supplier is an individual or a company that provides Diclazuril active pharmaceutical ingredient (API) or Diclazuril finished formulations upon request. The Diclazuril suppliers may include Diclazuril API manufacturers, exporters, distributors and traders.
click here to find a list of Diclazuril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diclazuril DMF (Drug Master File) is a document detailing the whole manufacturing process of Diclazuril active pharmaceutical ingredient (API) in detail. Different forms of Diclazuril DMFs exist exist since differing nations have different regulations, such as Diclazuril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diclazuril DMF submitted to regulatory agencies in the US is known as a USDMF. Diclazuril USDMF includes data on Diclazuril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diclazuril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diclazuril suppliers with USDMF on PharmaCompass.
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