01 1Jacobus Pharmaceutical Company, Inc
02 1Blank
01 1AMINOSALICYLATE SODIUM USP
02 1PARA-AMINOSALICYLIC ACID, SODIUM
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11697
Submission : 1995-10-03
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6909
Submission : 1987-04-03
Status : Inactive
Type : II
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A Aminosalicylic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminosalicylic Acid, including repackagers and relabelers. The FDA regulates Aminosalicylic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminosalicylic Acid 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 Aminosalicylic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aminosalicylic Acid supplier is an individual or a company that provides Aminosalicylic Acid active pharmaceutical ingredient (API) or Aminosalicylic Acid finished formulations upon request. The Aminosalicylic Acid suppliers may include Aminosalicylic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Aminosalicylic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aminosalicylic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Aminosalicylic Acid active pharmaceutical ingredient (API) in detail. Different forms of Aminosalicylic Acid DMFs exist exist since differing nations have different regulations, such as Aminosalicylic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aminosalicylic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Aminosalicylic Acid USDMF includes data on Aminosalicylic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aminosalicylic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aminosalicylic Acid suppliers with USDMF on PharmaCompass.
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