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 Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arginine, including repackagers and relabelers. The FDA regulates Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arginine supplier is an individual or a company that provides Arginine active pharmaceutical ingredient (API) or Arginine finished formulations upon request. The Arginine suppliers may include Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arginine DMF (Drug Master File) is a document detailing the whole manufacturing process of Arginine active pharmaceutical ingredient (API) in detail. Different forms of Arginine DMFs exist exist since differing nations have different regulations, such as Arginine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arginine DMF submitted to regulatory agencies in the US is known as a USDMF. Arginine USDMF includes data on Arginine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arginine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arginine suppliers with USDMF on PharmaCompass.
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