01 1BASF
02 1Huangshan Bonsun Pharmaceuticals
03 1Shanghai Yuking Water Soluble Material Tech
01 2COPOVIDONE
02 1KOLLIDON VA 64/KOLLIDON VA 64 FINE (COPOVIDONE)
01 2China
02 1Germany
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6745
Submission : 1986-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33953
Submission : 2019-07-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39828
Submission : 2024-04-10
Status : Active
Type : IV
A Copovidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copovidone, including repackagers and relabelers. The FDA regulates Copovidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copovidone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Copovidone supplier is an individual or a company that provides Copovidone active pharmaceutical ingredient (API) or Copovidone finished formulations upon request. The Copovidone suppliers may include Copovidone API manufacturers, exporters, distributors and traders.
click here to find a list of Copovidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copovidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Copovidone active pharmaceutical ingredient (API) in detail. Different forms of Copovidone DMFs exist exist since differing nations have different regulations, such as Copovidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copovidone DMF submitted to regulatory agencies in the US is known as a USDMF. Copovidone USDMF includes data on Copovidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copovidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copovidone suppliers with USDMF on PharmaCompass.
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