01 1Sumitomo Chemical
01 1DIPIVEFRIN HYDROCHLORIDE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9552
Submission : 1992-02-20
Status : Inactive
Type : II
98
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A Dipivefrin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipivefrin Hydrochloride, including repackagers and relabelers. The FDA regulates Dipivefrin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipivefrin 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.
A Dipivefrin Hydrochloride supplier is an individual or a company that provides Dipivefrin Hydrochloride active pharmaceutical ingredient (API) or Dipivefrin Hydrochloride finished formulations upon request. The Dipivefrin Hydrochloride suppliers may include Dipivefrin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dipivefrin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dipivefrin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipivefrin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dipivefrin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dipivefrin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipivefrin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dipivefrin Hydrochloride USDMF includes data on Dipivefrin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipivefrin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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