01 1ACS DOBFAR SPA
02 1Bristol Myers Squibb
03 2Chongqing DaXin Pharmaceutical
04 1Nektar Therapeutics
01 3AMIKACIN BASE
02 1AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG
03 1AMIKACIN PULMONARY DELIVERY SYSTEM
01 2China
02 1Italy
03 2U.S.A
01 1Active
02 4Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13762
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13527
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13760
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14007
Submission : 1999-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20987
Submission : 2007-10-31
Status : Inactive
Type : II
A Amikacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amikacin, including repackagers and relabelers. The FDA regulates Amikacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amikacin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amikacin supplier is an individual or a company that provides Amikacin active pharmaceutical ingredient (API) or Amikacin finished formulations upon request. The Amikacin suppliers may include Amikacin API manufacturers, exporters, distributors and traders.
click here to find a list of Amikacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amikacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Amikacin active pharmaceutical ingredient (API) in detail. Different forms of Amikacin DMFs exist exist since differing nations have different regulations, such as Amikacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amikacin DMF submitted to regulatory agencies in the US is known as a USDMF. Amikacin USDMF includes data on Amikacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amikacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amikacin suppliers with USDMF on PharmaCompass.
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