01 1AMINO GmbH
02 2Ajinomoto Company
03 1Kyowa Hakko Bio
04 2Mitsubishi Tanabe Pharma
05 1Nippon Kayaku
06 1SIGMA TAU
07 1SNJ Labs
01 1A-KETOANALOGUE TO ISOLEUCINE CALCIUM SALT
02 7L-ISOLEUCINE
03 1L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE
01 1Germany
02 1India
03 6Japan
04 1U.S.A
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29143
Submission : 2015-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-05
DMF Number : 21991
Submission : 2008-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4041
Submission : 1980-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2623
Submission : 1976-02-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9422
Submission : 1991-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1250
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4822
Submission : 1982-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9991
Submission : 1992-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38242
Submission : 2023-04-03
Status : Active
Type : II
A Isoleucine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoleucine, including repackagers and relabelers. The FDA regulates Isoleucine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoleucine 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 Isoleucine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoleucine supplier is an individual or a company that provides Isoleucine active pharmaceutical ingredient (API) or Isoleucine finished formulations upon request. The Isoleucine suppliers may include Isoleucine API manufacturers, exporters, distributors and traders.
click here to find a list of Isoleucine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoleucine DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoleucine active pharmaceutical ingredient (API) in detail. Different forms of Isoleucine DMFs exist exist since differing nations have different regulations, such as Isoleucine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoleucine DMF submitted to regulatory agencies in the US is known as a USDMF. Isoleucine USDMF includes data on Isoleucine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoleucine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoleucine suppliers with USDMF on PharmaCompass.
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