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01 1SAFC
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01 12,5-DIHYDROXYBENZOIC ACID
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01 1U.S.A
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01 1Inactive
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10577
Submission : 1993-11-08
Status : Inactive
Type : II
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PharmaCompass offers a list of Gentisic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gentisic Acid manufacturer or Gentisic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gentisic Acid manufacturer or Gentisic Acid supplier.
PharmaCompass also assists you with knowing the Gentisic Acid API Price utilized in the formulation of products. Gentisic Acid API Price is not always fixed or binding as the Gentisic Acid Price is obtained through a variety of data sources. The Gentisic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gentisan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentisan, including repackagers and relabelers. The FDA regulates Gentisan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentisan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Gentisan supplier is an individual or a company that provides Gentisan active pharmaceutical ingredient (API) or Gentisan finished formulations upon request. The Gentisan suppliers may include Gentisan API manufacturers, exporters, distributors and traders.
click here to find a list of Gentisan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentisan DMF (Drug Master File) is a document detailing the whole manufacturing process of Gentisan active pharmaceutical ingredient (API) in detail. Different forms of Gentisan DMFs exist exist since differing nations have different regulations, such as Gentisan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gentisan DMF submitted to regulatory agencies in the US is known as a USDMF. Gentisan USDMF includes data on Gentisan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gentisan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gentisan suppliers with USDMF on PharmaCompass.