Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
01 1DIFENOXIN HCL
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-15
Pay. Date : 2015-09-23
DMF Number : 12147
Submission : 1996-09-26
Status : Active
Type : II
A Difenoxin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difenoxin Hydrochloride, including repackagers and relabelers. The FDA regulates Difenoxin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difenoxin Hydrochloride 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 Difenoxin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difenoxin Hydrochloride supplier is an individual or a company that provides Difenoxin Hydrochloride active pharmaceutical ingredient (API) or Difenoxin Hydrochloride finished formulations upon request. The Difenoxin Hydrochloride suppliers may include Difenoxin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Difenoxin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difenoxin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Difenoxin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Difenoxin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Difenoxin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difenoxin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Difenoxin Hydrochloride USDMF includes data on Difenoxin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difenoxin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difenoxin Hydrochloride suppliers with USDMF on PharmaCompass.
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