01 1EPAX NORWAY AS
02 1SIGMA TAU
01 1EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER)
02 1L-AMINO-n-BUTYRIC ACID
01 1Norway
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
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 : 2951
Submission : 1977-05-26
Status : Inactive
Type : II
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PharmaCompass offers a list of Sodium Butyrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sodium Butyrate manufacturer or Sodium Butyrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Butyrate manufacturer or Sodium Butyrate supplier.
A butanate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of butanate, including repackagers and relabelers. The FDA regulates butanate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. butanate 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 butanate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A butanate supplier is an individual or a company that provides butanate active pharmaceutical ingredient (API) or butanate finished formulations upon request. The butanate suppliers may include butanate API manufacturers, exporters, distributors and traders.
click here to find a list of butanate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A butanate DMF (Drug Master File) is a document detailing the whole manufacturing process of butanate active pharmaceutical ingredient (API) in detail. Different forms of butanate DMFs exist exist since differing nations have different regulations, such as butanate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A butanate DMF submitted to regulatory agencies in the US is known as a USDMF. butanate USDMF includes data on butanate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The butanate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of butanate suppliers with USDMF on PharmaCompass.
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