01 2Bial
02 1MSN Laboratories
01 3OPICAPONE
01 1India
02 2Portugal
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34838
Submission : 2020-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32198
Submission : 2017-11-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38110
Submission : 2023-03-20
Status : Active
Type : II
A Opicapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Opicapone, including repackagers and relabelers. The FDA regulates Opicapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Opicapone 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 Opicapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Opicapone supplier is an individual or a company that provides Opicapone active pharmaceutical ingredient (API) or Opicapone finished formulations upon request. The Opicapone suppliers may include Opicapone API manufacturers, exporters, distributors and traders.
click here to find a list of Opicapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Opicapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Opicapone active pharmaceutical ingredient (API) in detail. Different forms of Opicapone DMFs exist exist since differing nations have different regulations, such as Opicapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Opicapone DMF submitted to regulatory agencies in the US is known as a USDMF. Opicapone USDMF includes data on Opicapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Opicapone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Opicapone suppliers with USDMF on PharmaCompass.
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