01 1ACS DOBFAR SPA
02 1AVT (Shanghai)
03 2Ajinomoto Company
04 2CordenPharma
05 1Mitsubishi Tanabe Pharma
06 2Orchid Pharma
01 1ARGININE
02 2ARGININE (STERILE BULK)
03 1CEFEPIME & ARGININE (STERILE BULK)
04 1CEFEPIME/L-ARGININE STERILE BLEND
05 3L-ARGININE
06 1L-ARGININE BASE
01 1China
02 2Germany
03 2India
04 1Italy
05 3Japan
01 7Active
02 2Inactive
01 3Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22918
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39434
Submission : 2024-04-30
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-04
Pay. Date : 2020-11-30
DMF Number : 31646
Submission : 2017-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39677
Submission : 2024-04-08
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-04
Pay. Date : 2014-05-23
DMF Number : 28191
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10131
Submission : 1989-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1929
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-09
Pay. Date : 2021-08-04
DMF Number : 18923
Submission : 2005-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18843
Submission : 2005-10-07
Status : Active
Type : II
A L-Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Arginine, including repackagers and relabelers. The FDA regulates L-Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Arginine 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 L-Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Arginine supplier is an individual or a company that provides L-Arginine active pharmaceutical ingredient (API) or L-Arginine finished formulations upon request. The L-Arginine suppliers may include L-Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Arginine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Arginine active pharmaceutical ingredient (API) in detail. Different forms of L-Arginine DMFs exist exist since differing nations have different regulations, such as L-Arginine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Arginine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Arginine USDMF includes data on L-Arginine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Arginine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Arginine suppliers with USDMF on PharmaCompass.
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