01 1SAFC
01 1CONTRACT STERILIZATION FACILITY IN GROVEPORT OHIO
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17020
Submission : 2003-12-11
Status : Inactive
Type : II
56
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A Dipro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipro, including repackagers and relabelers. The FDA regulates Dipro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipro 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 Dipro supplier is an individual or a company that provides Dipro active pharmaceutical ingredient (API) or Dipro finished formulations upon request. The Dipro suppliers may include Dipro API manufacturers, exporters, distributors and traders.
click here to find a list of Dipro suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dipro DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipro active pharmaceutical ingredient (API) in detail. Different forms of Dipro DMFs exist exist since differing nations have different regulations, such as Dipro USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipro DMF submitted to regulatory agencies in the US is known as a USDMF. Dipro USDMF includes data on Dipro's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipro USDMF is kept confidential to protect the manufacturer’s intellectual property.
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