Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cambrex Corporation
03 1Dasami Lab
04 1Industriale Chimica
05 1LAPICOR NV
06 1MSN Laboratories
07 1Maprimed
08 1Nira Life Sciences
09 1Romark
10 1Sun Pharmaceutical Industries Limited
11 1Suven Life Sciences Limited
01 10NITAZOXANIDE
02 1PLACEBO FOR CTM ALINIA® (NITAZOXANIDE) TABLETS, 500 MG
01 1Argentina
02 1Belgium
03 6India
04 1Italy
05 2U.S.A
01 10Active
02 1Inactive
01 4Complete
02 7Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-28
Pay. Date : 2020-08-06
DMF Number : 34169
Submission : 2019-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-27
Pay. Date : 2019-07-22
DMF Number : 33059
Submission : 2019-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23792
Submission : 2010-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12124
Submission : 1996-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-24
Pay. Date : 2019-12-03
DMF Number : 34150
Submission : 2019-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34555
Submission : 2020-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38408
Submission : 2023-05-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32425
Submission : 2018-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38996
Submission : 2023-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-08-02
DMF Number : 19752
Submission : 2006-09-08
Status : Active
Type : II
A Nitazoxanide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitazoxanide, including repackagers and relabelers. The FDA regulates Nitazoxanide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitazoxanide 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 Nitazoxanide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitazoxanide supplier is an individual or a company that provides Nitazoxanide active pharmaceutical ingredient (API) or Nitazoxanide finished formulations upon request. The Nitazoxanide suppliers may include Nitazoxanide API manufacturers, exporters, distributors and traders.
click here to find a list of Nitazoxanide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitazoxanide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitazoxanide active pharmaceutical ingredient (API) in detail. Different forms of Nitazoxanide DMFs exist exist since differing nations have different regulations, such as Nitazoxanide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitazoxanide DMF submitted to regulatory agencies in the US is known as a USDMF. Nitazoxanide USDMF includes data on Nitazoxanide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitazoxanide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitazoxanide suppliers with USDMF on PharmaCompass.
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