01 1EURAND
02 1Grace
03 1Recordati
04 1Wanbury Limited
01 2DIPHENHYDRAMINE CITRATE
02 1DIPHENHYDRAMINE CITRATE (MICROCAPS)
03 1DIPHENHYDRAMINE CITRATE, USP
01 1India
02 1Italy
03 2U.S.A
01 3Active
02 1Inactive
01 3Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12360
Submission : 1997-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-23
DMF Number : 11097
Submission : 1994-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-22
Pay. Date : 2023-09-05
DMF Number : 20334
Submission : 2007-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-06-15
DMF Number : 19986
Submission : 2006-11-15
Status : Active
Type : II
A Diphenhydramine Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diphenhydramine Citrate, including repackagers and relabelers. The FDA regulates Diphenhydramine Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diphenhydramine 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 Diphenhydramine Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diphenhydramine Citrate supplier is an individual or a company that provides Diphenhydramine Citrate active pharmaceutical ingredient (API) or Diphenhydramine Citrate finished formulations upon request. The Diphenhydramine Citrate suppliers may include Diphenhydramine Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Diphenhydramine Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diphenhydramine Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Diphenhydramine Citrate active pharmaceutical ingredient (API) in detail. Different forms of Diphenhydramine Citrate DMFs exist exist since differing nations have different regulations, such as Diphenhydramine Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diphenhydramine Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Diphenhydramine Citrate USDMF includes data on Diphenhydramine Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diphenhydramine Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diphenhydramine Citrate suppliers with USDMF on PharmaCompass.
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