Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Veranova
03 1Eli Lilly
04 1FDC
05 1GLAND PHARMA LIMITED
06 1Helsinn Advanced Synthesis
07 1Jinan Jinda Pharmaceutical Chemistry Co Ltd
08 1ScinoPharm Taiwan, Ltd
01 3DANTROLENE SODIUM
02 1DANTROLENE SODIUM (DTE)
03 1DANTROLENE SODIUM DRUG SUBSTANCE
04 1DANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE
05 1DANTROLENE SODIUM USP
06 1VIALS DANTRIUM (R)
01 1China
02 3India
03 1Switzerland
04 1Taiwan
05 2U.S.A
01 6Active
02 2Inactive
01 2Complete
02 6Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33845
Submission : 2019-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20779
Submission : 2007-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3664
Submission : 1979-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17446
Submission : 2004-05-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39305
Submission : 2024-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19498
Submission : 2006-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-06
Pay. Date : 2014-02-14
DMF Number : 15167
Submission : 2000-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-21
Pay. Date : 2012-11-23
DMF Number : 16118
Submission : 2002-08-23
Status : Active
Type : II
A Dantrolene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dantrolene, including repackagers and relabelers. The FDA regulates Dantrolene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dantrolene 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 Dantrolene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dantrolene supplier is an individual or a company that provides Dantrolene active pharmaceutical ingredient (API) or Dantrolene finished formulations upon request. The Dantrolene suppliers may include Dantrolene API manufacturers, exporters, distributors and traders.
click here to find a list of Dantrolene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dantrolene DMF (Drug Master File) is a document detailing the whole manufacturing process of Dantrolene active pharmaceutical ingredient (API) in detail. Different forms of Dantrolene DMFs exist exist since differing nations have different regulations, such as Dantrolene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dantrolene DMF submitted to regulatory agencies in the US is known as a USDMF. Dantrolene USDMF includes data on Dantrolene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dantrolene USDMF is kept confidential to protect the manufacturer’s intellectual property.
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