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 1China
02 15Japan
03 1U.S.A
04 1Blank
01 7Active
02 11Inactive
01 1Valid
02 17Blank
01 18Blank
01 18Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15386
Submission : 2001-04-18
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
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 : 27952
Submission : 2014-01-29
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 : Reviewed
Rev. Date : 2013-02-05
Pay. Date : 2013-01-25
DMF Number : 3149
Submission : 1978-03-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 1076
Submission : 1967-08-15
Status : Active
Type : II
Certificate Number : R1-CEP 2009-100 - Rev 00
Issue Date : 2014-12-16
Type : Chemical
Substance Number : 770
Status : Valid
NDC Package Code : 51495-178
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (22.01kg/100kg 12.23kg/100kg 10.95kg/100kg 5.1kg/100kg 6.38kg/100kg 7.76kg/100kg 7.71kg/100kg 4.25kg/100kg 7.23kg/100kg 5.32kg/100kg 4.47kg/100kg .43kg/100kg 6.17kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 4555
Submission : 1982-03-17
Status : Active
Type : II
NDC Package Code : 51495-178
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (22.01kg/100kg 12.23kg/100kg 10.95kg/100kg 5.1kg/100kg 6.38kg/100kg 7.76kg/100kg 7.71kg/100kg 4.25kg/100kg 7.23kg/100kg 5.32kg/100kg 4.47kg/100kg .43kg/100kg 6.17kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5896
Submission : 1985-06-24
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 4194
Submission : 1981-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4202
Submission : 1981-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4259
Submission : 1981-07-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6062
Submission : 1985-09-25
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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
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 : 3223
Submission : 1978-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3407
Submission : 1979-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17467
Submission : 2004-05-24
Status : Inactive
Type : II
NDC Package Code : 51495-178
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (22.01kg/100kg 12.23kg/100kg 10.95kg/100kg 5.1kg/100kg 6.38kg/100kg 7.76kg/100kg 7.71kg/100kg 4.25kg/100kg 7.23kg/100kg 5.32kg/100kg 4.47kg/100kg .43kg/100kg 6.17kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
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.
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