01 1AMINO GmbH
02 2Ajinomoto Company
03 1Daiichi Sankyo
04 1Mitsubishi Tanabe Pharma
05 1SIGMA TAU
06 1SNJ Labs
07 1UQUIFA
08 1Blank
01 12-ISOPROPYL-4-(N-METHYL) AMINOMETHYLTHIAZOYLCARBONYL-(L)-VALINE
02 1A-KETOANALOGUE TO VALINE CALCIUM SALT
03 7L-VALINE
01 1Germany
02 1India
03 4Japan
04 1Spain
05 1U.S.A
06 1Blank
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31561
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29141
Submission : 2015-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12720
Submission : 1997-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6933
Submission : 1987-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1253
Submission : 1968-10-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2765
Submission : 1976-10-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38246
Submission : 2023-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11670
Submission : 1995-09-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7454
Submission : 1988-04-19
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Valine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valine, including repackagers and relabelers. The FDA regulates Valine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valine 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 Valine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valine supplier is an individual or a company that provides Valine active pharmaceutical ingredient (API) or Valine finished formulations upon request. The Valine suppliers may include Valine API manufacturers, exporters, distributors and traders.
click here to find a list of Valine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valine DMF (Drug Master File) is a document detailing the whole manufacturing process of Valine active pharmaceutical ingredient (API) in detail. Different forms of Valine DMFs exist exist since differing nations have different regulations, such as Valine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valine DMF submitted to regulatory agencies in the US is known as a USDMF. Valine USDMF includes data on Valine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valine suppliers with USDMF on PharmaCompass.
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