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