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