Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Nantong Jinghua Pharmaceutical
03 1PROVENTUS LIFE SCIENCES PVT LTD
04 1Siegfried AG
05 1Wyeth Pharmaceuticals Inc
06 1Blank
01 1MYSOLINE (PRIMIDONE) TABLETS
02 4PRIMIDONE
03 1PRIMIDONE USP XXII
01 1China
02 2India
03 1Switzerland
04 1U.S.A
05 1Blank
01 3Active
02 3Inactive
01 3Complete
02 3Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-30
Pay. Date : 2022-12-27
DMF Number : 35202
Submission : 2020-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-04-02
DMF Number : 21602
Submission : 2008-05-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23444
Submission : 2010-01-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-28
Pay. Date : 2023-03-23
DMF Number : 2199
Submission : 1973-12-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4912
Submission : 1983-04-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8406
Submission : 1990-01-30
Status : Inactive
Type : II
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A Primidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primidone, including repackagers and relabelers. The FDA regulates Primidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primidone 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 Primidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Primidone supplier is an individual or a company that provides Primidone active pharmaceutical ingredient (API) or Primidone finished formulations upon request. The Primidone suppliers may include Primidone API manufacturers, exporters, distributors and traders.
click here to find a list of Primidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Primidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Primidone active pharmaceutical ingredient (API) in detail. Different forms of Primidone DMFs exist exist since differing nations have different regulations, such as Primidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Primidone DMF submitted to regulatory agencies in the US is known as a USDMF. Primidone USDMF includes data on Primidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Primidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Primidone suppliers with USDMF on PharmaCompass.
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