01 1Polaris AI Pharma
01 1GADODIAMIDE
01 1South Korea
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29629
Submission : 2015-10-05
Status : Active
Type : II
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A Omniscan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omniscan, including repackagers and relabelers. The FDA regulates Omniscan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omniscan 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 Omniscan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Omniscan supplier is an individual or a company that provides Omniscan active pharmaceutical ingredient (API) or Omniscan finished formulations upon request. The Omniscan suppliers may include Omniscan API manufacturers, exporters, distributors and traders.
click here to find a list of Omniscan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Omniscan DMF (Drug Master File) is a document detailing the whole manufacturing process of Omniscan active pharmaceutical ingredient (API) in detail. Different forms of Omniscan DMFs exist exist since differing nations have different regulations, such as Omniscan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omniscan DMF submitted to regulatory agencies in the US is known as a USDMF. Omniscan USDMF includes data on Omniscan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omniscan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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