01 1BASF
02 1NOF CORPORATION
01 1KOLLIDON®CL GRADES(CROSPOVIDONE)
02 1POLY(OXY-1,2-ETHANEDIYL), ALPHA-METHYL -OMEGA-{6-[(2,5-DIOXO-1 -PYRROLIDINYL)OXY]-6-OXOHEXYLOXY}
01 1Germany
02 1Japan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22604
Submission : 2009-01-19
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28873
Submission : 2014-11-26
Status : Active
Type : II
A Povidone API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Povidone API, including repackagers and relabelers. The FDA regulates Povidone API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Povidone API 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 Povidone API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Povidone API supplier is an individual or a company that provides Povidone API active pharmaceutical ingredient (API) or Povidone API finished formulations upon request. The Povidone API suppliers may include Povidone API API manufacturers, exporters, distributors and traders.
click here to find a list of Povidone API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Povidone API DMF (Drug Master File) is a document detailing the whole manufacturing process of Povidone API active pharmaceutical ingredient (API) in detail. Different forms of Povidone API DMFs exist exist since differing nations have different regulations, such as Povidone API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Povidone API DMF submitted to regulatory agencies in the US is known as a USDMF. Povidone API USDMF includes data on Povidone API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Povidone API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Povidone API suppliers with USDMF on PharmaCompass.
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