01 1Fuji Chemical Industry
02 1Nifty Labs
03 1Procos
01 11-(4- FLUOROBENZYL)-2-CHLOROBENZIMIDAZOLE HYDROCHLORIDE MONOHYDRATE
02 12-[[[3-METHYL-4-(2,2,2-TRIFLUORO ETHOXY)-2-PYRIDINYL] METHYL] SULFANYL]-1H-BENZIMIDAZOLE
03 1KB-2413,1-(2-ETHOXYETHYL)-2-(4-METHYL-I-HOMOPIPERAZINYL)BENZIMIDAZOLE
01 1India
02 1Italy
03 1Japan
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6167
Submission : 1986-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29045
Submission : 2015-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15105
Submission : 2000-10-13
Status : Inactive
Type : II
A Benzimidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzimidazole, including repackagers and relabelers. The FDA regulates Benzimidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzimidazole 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 Benzimidazole supplier is an individual or a company that provides Benzimidazole active pharmaceutical ingredient (API) or Benzimidazole finished formulations upon request. The Benzimidazole suppliers may include Benzimidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Benzimidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzimidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzimidazole active pharmaceutical ingredient (API) in detail. Different forms of Benzimidazole DMFs exist exist since differing nations have different regulations, such as Benzimidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzimidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Benzimidazole USDMF includes data on Benzimidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzimidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzimidazole suppliers with USDMF on PharmaCompass.
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