01 1Cadila Pharmaceuticals
02 1Pfizer Inc
01 1BENADRYL POWDER
02 1DIPHENHYDRAMINE TANNATE
01 1India
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20820
Submission : 2007-08-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1036
Submission : 1967-02-02
Status : Inactive
Type : II
A Diphenhydramine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diphenhydramine, including repackagers and relabelers. The FDA regulates Diphenhydramine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diphenhydramine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diphenhydramine supplier is an individual or a company that provides Diphenhydramine active pharmaceutical ingredient (API) or Diphenhydramine finished formulations upon request. The Diphenhydramine suppliers may include Diphenhydramine API manufacturers, exporters, distributors and traders.
click here to find a list of Diphenhydramine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diphenhydramine DMF (Drug Master File) is a document detailing the whole manufacturing process of Diphenhydramine active pharmaceutical ingredient (API) in detail. Different forms of Diphenhydramine DMFs exist exist since differing nations have different regulations, such as Diphenhydramine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diphenhydramine DMF submitted to regulatory agencies in the US is known as a USDMF. Diphenhydramine USDMF includes data on Diphenhydramine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diphenhydramine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diphenhydramine suppliers with USDMF on PharmaCompass.
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