01 1S D Fine Chem Limited
01 1SODIUM HYDROXIDE PELLETS BP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28719
Submission : 2014-10-03
Status : Active
Type : IV
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A I14-102868 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of I14-102868, including repackagers and relabelers. The FDA regulates I14-102868 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. I14-102868 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 I14-102868 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A I14-102868 supplier is an individual or a company that provides I14-102868 active pharmaceutical ingredient (API) or I14-102868 finished formulations upon request. The I14-102868 suppliers may include I14-102868 API manufacturers, exporters, distributors and traders.
click here to find a list of I14-102868 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A I14-102868 DMF (Drug Master File) is a document detailing the whole manufacturing process of I14-102868 active pharmaceutical ingredient (API) in detail. Different forms of I14-102868 DMFs exist exist since differing nations have different regulations, such as I14-102868 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A I14-102868 DMF submitted to regulatory agencies in the US is known as a USDMF. I14-102868 USDMF includes data on I14-102868's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The I14-102868 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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