01 2ACS DOBFAR SPA
02 1Abbott Laboratories
03 1Bristol Myers Squibb
04 2Chongqing DaXin Pharmaceutical
05 1Qilu Tianhe Pharmaceutical Co., Ltd.
06 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
01 1AMIKACIN 1.8 SULPHATE
02 3AMIKACIN SULFATE
03 1AMIKACIN SULFATE (1:2) USP
04 1AMIKACIN SULFATE USP
05 1AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
06 1Amikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance
01 4China
02 2Italy
03 2U.S.A
01 2Active
02 6Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13756
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 13763
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22732
Submission : 2009-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13722
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21035
Submission : 2007-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13788
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 20874
Submission : 2007-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27776
Submission : 2013-11-27
Status : Inactive
Type : II
A Amikacin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amikacin Sulfate, including repackagers and relabelers. The FDA regulates Amikacin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amikacin Sulfate 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 Amikacin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amikacin Sulfate supplier is an individual or a company that provides Amikacin Sulfate active pharmaceutical ingredient (API) or Amikacin Sulfate finished formulations upon request. The Amikacin Sulfate suppliers may include Amikacin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Amikacin Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amikacin Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amikacin Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Amikacin Sulfate DMFs exist exist since differing nations have different regulations, such as Amikacin Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amikacin Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Amikacin Sulfate USDMF includes data on Amikacin Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amikacin Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amikacin Sulfate suppliers with USDMF on PharmaCompass.
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