01 3Ajinomoto Company
02 1Irvine Scientific Sales Company
03 5Kyowa Hakko Bio
04 4Mitsubishi Tanabe Pharma
05 1Nippon Kayaku
06 1Nippon Rikagaku Yakuhin
07 1SHANGHAI KYOWA AMINO ACID CO., LTD.
08 1Wenda
09 1Blank
01 1AMINO ACID
02 1AMINO ACID BLEND "KYOWA",TYPE TR-1
03 1AMINO ACID MIXTURE
04 1AMINO ACID MIXTURE ABBC
05 1AMINO ACID MIXTURE ABBU
06 1AMINO ACID MIXTURE ABBX
07 1AMINO ACID MIXTURE BAX-D
08 1AMINO ACID MIXTURES
09 1AMINO ACID PRODUCTS
10 7AMINO ACIDS
11 1EFFERVES (AMINO ACID COMPLEX)
12 1NON-ESSENTIAL AMINO ACIDS 100X FOR MEM-LIQUID
01 1China
02 15Japan
03 1U.S.A
04 1Blank
01 7Active
02 11Inactive
01 4Complete
02 14Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 4555
Submission : 1982-03-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 1076
Submission : 1967-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27952
Submission : 2014-01-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-05
Pay. Date : 2013-01-25
DMF Number : 3149
Submission : 1978-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3131
Submission : 1978-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2631
Submission : 1976-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1990
Submission : 1972-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-03
Pay. Date : 2020-05-21
DMF Number : 32088
Submission : 2017-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15386
Submission : 2001-04-18
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28
Submission : 1946-09-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A AMINO ACIDS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMINO ACIDS, including repackagers and relabelers. The FDA regulates AMINO ACIDS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMINO ACIDS API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A AMINO ACIDS supplier is an individual or a company that provides AMINO ACIDS active pharmaceutical ingredient (API) or AMINO ACIDS finished formulations upon request. The AMINO ACIDS suppliers may include AMINO ACIDS API manufacturers, exporters, distributors and traders.
click here to find a list of AMINO ACIDS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMINO ACIDS DMF (Drug Master File) is a document detailing the whole manufacturing process of AMINO ACIDS active pharmaceutical ingredient (API) in detail. Different forms of AMINO ACIDS DMFs exist exist since differing nations have different regulations, such as AMINO ACIDS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMINO ACIDS DMF submitted to regulatory agencies in the US is known as a USDMF. AMINO ACIDS USDMF includes data on AMINO ACIDS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMINO ACIDS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMINO ACIDS suppliers with USDMF on PharmaCompass.
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