01 1Ajinomoto OmniChem N.V.
02 1Curia
03 1Fujifilm Diosynth Biotechnologies
01 1BOC CORE SUCCINATE
02 1BOC CORE SUCCINATE A88820.605
03 1PREGNENOLONE HEMISUCCINATE
01 1Belgium
02 1U.S.A
03 1United Kingdom
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11374
Submission : 1995-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11673
Submission : 1995-09-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4045
Submission : 1981-01-16
Status : Inactive
Type : II
A Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Succinate, including repackagers and relabelers. The FDA regulates Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Succinate 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 Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Succinate supplier is an individual or a company that provides Succinate active pharmaceutical ingredient (API) or Succinate finished formulations upon request. The Succinate suppliers may include Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Succinate active pharmaceutical ingredient (API) in detail. Different forms of Succinate DMFs exist exist since differing nations have different regulations, such as Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Succinate USDMF includes data on Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Succinate suppliers with USDMF on PharmaCompass.
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