01 1Corden Pharma Bergamo S.p.A
02 1Gedeon Richter
01 2CIMETIDINE HYDROCHLORIDE
01 1Hungary
02 1Italy
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11583
Submission : 1995-07-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9769
Submission : 1992-07-08
Status : Inactive
Type : II
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A Histodil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Histodil, including repackagers and relabelers. The FDA regulates Histodil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Histodil 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 Histodil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Histodil supplier is an individual or a company that provides Histodil active pharmaceutical ingredient (API) or Histodil finished formulations upon request. The Histodil suppliers may include Histodil API manufacturers, exporters, distributors and traders.
click here to find a list of Histodil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Histodil DMF (Drug Master File) is a document detailing the whole manufacturing process of Histodil active pharmaceutical ingredient (API) in detail. Different forms of Histodil DMFs exist exist since differing nations have different regulations, such as Histodil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Histodil DMF submitted to regulatory agencies in the US is known as a USDMF. Histodil USDMF includes data on Histodil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Histodil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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