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 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14524
Submission : 1999-11-15
Status : Inactive
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
29
PharmaCompass offers a list of Gemifloxacin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gemifloxacin manufacturer or Gemifloxacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gemifloxacin manufacturer or Gemifloxacin supplier.
PharmaCompass also assists you with knowing the Gemifloxacin API Price utilized in the formulation of products. Gemifloxacin API Price is not always fixed or binding as the Gemifloxacin Price is obtained through a variety of data sources. The Gemifloxacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Factive manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Factive, including repackagers and relabelers. The FDA regulates Factive manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Factive 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 Factive manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Factive supplier is an individual or a company that provides Factive active pharmaceutical ingredient (API) or Factive finished formulations upon request. The Factive suppliers may include Factive API manufacturers, exporters, distributors and traders.
click here to find a list of Factive suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Factive DMF (Drug Master File) is a document detailing the whole manufacturing process of Factive active pharmaceutical ingredient (API) in detail. Different forms of Factive DMFs exist exist since differing nations have different regulations, such as Factive USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Factive DMF submitted to regulatory agencies in the US is known as a USDMF. Factive USDMF includes data on Factive's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Factive USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Factive suppliers with USDMF on PharmaCompass.
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