01 1LG Life Sciences
02 1Maithri Drugs
03 1Orchid Pharma
01 1GEMIFLOXACIN MESYLATE
02 1GEMIFLOXACIN MESYLATE (NON-STERILE BULK API)
03 1GEMIFLOXACIN MESYLATE USP
01 2India
02 1South Korea
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14524
Submission : 1999-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37897
Submission : 2023-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21238
Submission : 2008-01-31
Status : Active
Type : II
A Gemifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemifloxacin, including repackagers and relabelers. The FDA regulates Gemifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemifloxacin 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 Gemifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemifloxacin supplier is an individual or a company that provides Gemifloxacin active pharmaceutical ingredient (API) or Gemifloxacin finished formulations upon request. The Gemifloxacin suppliers may include Gemifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Gemifloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemifloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemifloxacin active pharmaceutical ingredient (API) in detail. Different forms of Gemifloxacin DMFs exist exist since differing nations have different regulations, such as Gemifloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemifloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Gemifloxacin USDMF includes data on Gemifloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemifloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemifloxacin suppliers with USDMF on PharmaCompass.
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