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