01 1Kaken Pharmaceuticals
01 1SOFPIRONIUM BROMIDE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31310
Submission : 2017-09-22
Status : Active
Type : II
A Sofpironium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofpironium Bromide, including repackagers and relabelers. The FDA regulates Sofpironium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofpironium Bromide 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 Sofpironium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sofpironium Bromide supplier is an individual or a company that provides Sofpironium Bromide active pharmaceutical ingredient (API) or Sofpironium Bromide finished formulations upon request. The Sofpironium Bromide suppliers may include Sofpironium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Sofpironium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sofpironium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sofpironium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Sofpironium Bromide DMFs exist exist since differing nations have different regulations, such as Sofpironium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sofpironium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Sofpironium Bromide USDMF includes data on Sofpironium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sofpironium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sofpironium Bromide suppliers with USDMF on PharmaCompass.
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