01 1Smruthi Organics
02 1Turtle Pharma
03 1Viatris
01 3ENROFLOXACIN USP
01 2India
02 1U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24857
Submission : 2011-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33249
Submission : 2018-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20625
Submission : 2007-06-19
Status : Active
Type : II
A Enrofloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enrofloxacin, including repackagers and relabelers. The FDA regulates Enrofloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enrofloxacin 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 Enrofloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enrofloxacin supplier is an individual or a company that provides Enrofloxacin active pharmaceutical ingredient (API) or Enrofloxacin finished formulations upon request. The Enrofloxacin suppliers may include Enrofloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Enrofloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enrofloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Enrofloxacin active pharmaceutical ingredient (API) in detail. Different forms of Enrofloxacin DMFs exist exist since differing nations have different regulations, such as Enrofloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enrofloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Enrofloxacin USDMF includes data on Enrofloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enrofloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enrofloxacin suppliers with USDMF on PharmaCompass.
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