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