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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 D-Serine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Serine API, including repackagers and relabelers. The FDA regulates D-Serine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Serine API 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 D-Serine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A D-Serine API supplier is an individual or a company that provides D-Serine API active pharmaceutical ingredient (API) or D-Serine API finished formulations upon request. The D-Serine API suppliers may include D-Serine API API manufacturers, exporters, distributors and traders.
click here to find a list of D-Serine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Serine API DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Serine API active pharmaceutical ingredient (API) in detail. Different forms of D-Serine API DMFs exist exist since differing nations have different regulations, such as D-Serine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Serine API DMF submitted to regulatory agencies in the US is known as a USDMF. D-Serine API USDMF includes data on D-Serine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Serine API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Serine API suppliers with USDMF on PharmaCompass.
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