01 1ACS DOBFAR SPA
02 1Jungbunzlauer International AG
03 1Merck Group
01 1STERILE TRISODIUM CITRATE DIHYDRATE
02 2TRISODIUM CITRATE DIHYDRATE
01 1Germany
02 1Italy
03 1Switzerland
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11809
Submission : 1996-01-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-02
Pay. Date : 2019-01-28
DMF Number : 32842
Submission : 2018-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-30
Pay. Date : 2016-11-01
DMF Number : 29906
Submission : 2015-12-07
Status : Active
Type : II
A Trisodium Citrate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trisodium Citrate Dihydrate, including repackagers and relabelers. The FDA regulates Trisodium Citrate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trisodium Citrate Dihydrate supplier is an individual or a company that provides Trisodium Citrate Dihydrate active pharmaceutical ingredient (API) or Trisodium Citrate Dihydrate finished formulations upon request. The Trisodium Citrate Dihydrate suppliers may include Trisodium Citrate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Trisodium Citrate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trisodium Citrate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Trisodium Citrate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Trisodium Citrate Dihydrate DMFs exist exist since differing nations have different regulations, such as Trisodium Citrate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trisodium Citrate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Trisodium Citrate Dihydrate USDMF includes data on Trisodium Citrate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trisodium Citrate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trisodium Citrate Dihydrate suppliers with USDMF on PharmaCompass.
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