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01 1Kyowa Hakko Bio
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01 1D-SERINE (BULK SUBSTANCE)
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01 1Japan
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01 1Inactive
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19001
Submission : 2005-12-05
Status : Inactive
Type : II
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PharmaCompass offers a list of D-Serine API 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 D-Serine API manufacturer or D-Serine API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred D-Serine API manufacturer or D-Serine API supplier.
PharmaCompass also assists you with knowing the D-Serine API API Price utilized in the formulation of products. D-Serine API API Price is not always fixed or binding as the D-Serine API Price is obtained through a variety of data sources. The D-Serine API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DSN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSN, including repackagers and relabelers. The FDA regulates DSN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSN 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 DSN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DSN supplier is an individual or a company that provides DSN active pharmaceutical ingredient (API) or DSN finished formulations upon request. The DSN suppliers may include DSN API manufacturers, exporters, distributors and traders.
click here to find a list of DSN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSN DMF (Drug Master File) is a document detailing the whole manufacturing process of DSN active pharmaceutical ingredient (API) in detail. Different forms of DSN DMFs exist exist since differing nations have different regulations, such as DSN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSN DMF submitted to regulatory agencies in the US is known as a USDMF. DSN USDMF includes data on DSN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSN suppliers with USDMF on PharmaCompass.