01 1Anmol Chemicals
01 1MONOSODIUM CITRATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39459
Submission : 2024-02-06
Status : Active
Type : IV
A Sodium Dihydrogen Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Dihydrogen Citrate, including repackagers and relabelers. The FDA regulates Sodium Dihydrogen Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Dihydrogen Citrate 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 Dihydrogen Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Dihydrogen Citrate supplier is an individual or a company that provides Sodium Dihydrogen Citrate active pharmaceutical ingredient (API) or Sodium Dihydrogen Citrate finished formulations upon request. The Sodium Dihydrogen Citrate suppliers may include Sodium Dihydrogen Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Dihydrogen Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Dihydrogen Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Dihydrogen Citrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Dihydrogen Citrate DMFs exist exist since differing nations have different regulations, such as Sodium Dihydrogen Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Dihydrogen Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Dihydrogen Citrate USDMF includes data on Sodium Dihydrogen Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Dihydrogen Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Dihydrogen Citrate suppliers with USDMF on PharmaCompass.
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