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