01 1ACS DOBFAR SPA
02 1Bayer AG
03 1FUJIAN FUKANG PHARMACEUTICAL
04 1Fermic
05 1Kaifeng Pharmaceutical Group Co., Ltd
06 1Lek Pharmaceuticals
07 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
08 1Meiji Seika Pharma
09 1SHANGHAI ASIA PHARMACEUTICAL CO LTD
10 1Sichuan Long March Pharmaceutical Co. Ltd.
11 3Blank
01 12GENTAMICIN SULFATE
02 1GENTAMYCIN SULFATE
01 5China
02 1Germany
03 1Italy
04 1Japan
05 1Mexico
06 1Slovenia
07 3Blank
01 4Active
02 9Inactive
01 2Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24198
Submission : 2010-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13437
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 12048
Submission : 1996-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13704
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-14
Pay. Date : 2019-04-10
DMF Number : 30693
Submission : 2016-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13658
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13630
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13637
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13671
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13625
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Gentamicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentamicin, including repackagers and relabelers. The FDA regulates Gentamicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentamicin 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 Gentamicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gentamicin supplier is an individual or a company that provides Gentamicin active pharmaceutical ingredient (API) or Gentamicin finished formulations upon request. The Gentamicin suppliers may include Gentamicin API manufacturers, exporters, distributors and traders.
click here to find a list of Gentamicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentamicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gentamicin active pharmaceutical ingredient (API) in detail. Different forms of Gentamicin DMFs exist exist since differing nations have different regulations, such as Gentamicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gentamicin DMF submitted to regulatory agencies in the US is known as a USDMF. Gentamicin USDMF includes data on Gentamicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gentamicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gentamicin suppliers with USDMF on PharmaCompass.
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