01 1S D Fine Chem Limited
01 1CREATININE USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28685
Submission : 2014-09-29
Status : Active
Type : IV
99
PharmaCompass offers a list of Creatinine 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 Creatinine manufacturer or Creatinine supplier for your needs.
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PharmaCompass also assists you with knowing the Creatinine API Price utilized in the formulation of products. Creatinine API Price is not always fixed or binding as the Creatinine Price is obtained through a variety of data sources. The Creatinine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1-Methylhydantoin-2-imide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Methylhydantoin-2-imide, including repackagers and relabelers. The FDA regulates 1-Methylhydantoin-2-imide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Methylhydantoin-2-imide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1-Methylhydantoin-2-imide supplier is an individual or a company that provides 1-Methylhydantoin-2-imide active pharmaceutical ingredient (API) or 1-Methylhydantoin-2-imide finished formulations upon request. The 1-Methylhydantoin-2-imide suppliers may include 1-Methylhydantoin-2-imide API manufacturers, exporters, distributors and traders.
click here to find a list of 1-Methylhydantoin-2-imide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-Methylhydantoin-2-imide DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-Methylhydantoin-2-imide active pharmaceutical ingredient (API) in detail. Different forms of 1-Methylhydantoin-2-imide DMFs exist exist since differing nations have different regulations, such as 1-Methylhydantoin-2-imide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-Methylhydantoin-2-imide DMF submitted to regulatory agencies in the US is known as a USDMF. 1-Methylhydantoin-2-imide USDMF includes data on 1-Methylhydantoin-2-imide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-Methylhydantoin-2-imide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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