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