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