01 1Anmol Chemicals
02 1Solvay Chemicals International S.A
01 1LITHIUM CITRATE SYRUP
02 1LITHIUM CITRATE USP/BP
01 1Belgium
02 1India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37189
Submission : 2022-06-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1320
Submission : 1969-02-10
Status : Inactive
Type : II
A Lithium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lithium Citrate, including repackagers and relabelers. The FDA regulates Lithium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lithium 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.
A Lithium Citrate supplier is an individual or a company that provides Lithium Citrate active pharmaceutical ingredient (API) or Lithium Citrate finished formulations upon request. The Lithium Citrate suppliers may include Lithium Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Lithium Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lithium Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lithium Citrate active pharmaceutical ingredient (API) in detail. Different forms of Lithium Citrate DMFs exist exist since differing nations have different regulations, such as Lithium Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lithium Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Lithium Citrate USDMF includes data on Lithium Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lithium Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lithium Citrate suppliers with USDMF on PharmaCompass.
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