01 1EPAX NORWAY AS
02 1SAFC
03 1SIGMA TAU
01 1BUTYRIC ACID
02 1EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER)
03 1L-AMINO-n-BUTYRIC ACID
01 1Norway
02 2U.S.A
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25223
Submission : 2011-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10227
Submission : 1993-04-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2951
Submission : 1977-05-26
Status : Inactive
Type : II
A Sodium Butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Butyrate, including repackagers and relabelers. The FDA regulates Sodium Butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Butyrate 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 Sodium Butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Butyrate supplier is an individual or a company that provides Sodium Butyrate active pharmaceutical ingredient (API) or Sodium Butyrate finished formulations upon request. The Sodium Butyrate suppliers may include Sodium Butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Butyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Butyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Butyrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Butyrate DMFs exist exist since differing nations have different regulations, such as Sodium Butyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Butyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Butyrate USDMF includes data on Sodium Butyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Butyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Butyrate suppliers with USDMF on PharmaCompass.
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