Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Agno Pharma
03 1Aurobindo Pharma Limited
04 1Dishman Carbogen Amcis
05 1Emcure Pharmaceuticals
06 1MSN Laboratories
07 1SAFC
08 1Suven Pharmaceuticals
09 1Viatris
01 9ISOSULFAN BLUE
01 6India
02 3U.S.A
01 8Active
02 1Inactive
01 6Complete
02 3Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-08
Pay. Date : 2015-09-29
DMF Number : 29829
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34975
Submission : 2020-07-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-23
DMF Number : 27795
Submission : 2013-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-02
Pay. Date : 2017-05-19
DMF Number : 31226
Submission : 2016-12-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-07-31
DMF Number : 33199
Submission : 2018-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-19
Pay. Date : 2020-09-03
DMF Number : 34717
Submission : 2020-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20891
Submission : 2007-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-12
Pay. Date : 2023-09-01
DMF Number : 37258
Submission : 2022-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21883
Submission : 2008-08-13
Status : Active
Type : II
A Isosulfan Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosulfan Blue, including repackagers and relabelers. The FDA regulates Isosulfan Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosulfan Blue 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 Isosulfan Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosulfan Blue supplier is an individual or a company that provides Isosulfan Blue active pharmaceutical ingredient (API) or Isosulfan Blue finished formulations upon request. The Isosulfan Blue suppliers may include Isosulfan Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Isosulfan Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosulfan Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosulfan Blue active pharmaceutical ingredient (API) in detail. Different forms of Isosulfan Blue DMFs exist exist since differing nations have different regulations, such as Isosulfan Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isosulfan Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Isosulfan Blue USDMF includes data on Isosulfan Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosulfan Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isosulfan Blue suppliers with USDMF on PharmaCompass.
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