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 DIPTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DIPTA, including repackagers and relabelers. The FDA regulates DIPTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DIPTA 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 DIPTA supplier is an individual or a company that provides DIPTA active pharmaceutical ingredient (API) or DIPTA finished formulations upon request. The DIPTA suppliers may include DIPTA API manufacturers, exporters, distributors and traders.
click here to find a list of DIPTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DIPTA DMF (Drug Master File) is a document detailing the whole manufacturing process of DIPTA active pharmaceutical ingredient (API) in detail. Different forms of DIPTA DMFs exist exist since differing nations have different regulations, such as DIPTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DIPTA DMF submitted to regulatory agencies in the US is known as a USDMF. DIPTA USDMF includes data on DIPTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DIPTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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