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01 1Hebei Jiheng Pharmaceutical Co Ltd
02 1Shandong Xinhua Pharmaceutical
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01 1DIPYRONE (METAMIZOLE SODIUM MONOHYDRATE)
02 1METAMIZOLE SODIUM
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01 2China
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01 1Active
02 1Inactive
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01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17006
Submission : 2003-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31035
Submission : 2016-10-19
Status : Active
Type : II
A Dipyrone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipyrone, including repackagers and relabelers. The FDA regulates Dipyrone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipyrone 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 Dipyrone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dipyrone supplier is an individual or a company that provides Dipyrone active pharmaceutical ingredient (API) or Dipyrone finished formulations upon request. The Dipyrone suppliers may include Dipyrone API manufacturers, exporters, distributors and traders.
click here to find a list of Dipyrone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dipyrone DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipyrone active pharmaceutical ingredient (API) in detail. Different forms of Dipyrone DMFs exist exist since differing nations have different regulations, such as Dipyrone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipyrone DMF submitted to regulatory agencies in the US is known as a USDMF. Dipyrone USDMF includes data on Dipyrone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipyrone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dipyrone suppliers with USDMF on PharmaCompass.
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