Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 2Catalent Pharma Solutions
03 1Dasami Lab
04 1Lusochimica
05 1UQUIFA
01 3NIMODIPINE
02 1NIMODIPINE (MICRONIZED)
03 1NIMODIPINE 30MG SOFTGEL CAPSULES
04 1NIMODIPINE 30MG SOFTGELS
01 2India
02 1Italy
03 1Spain
04 2U.S.A
01 4Active
02 2Inactive
01 3Complete
02 3Blank
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 : 34203
Submission : 2019-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18373
Submission : 2005-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15598
Submission : 2001-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-10-26
DMF Number : 32971
Submission : 2018-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-18
Pay. Date : 2017-06-07
DMF Number : 14979
Submission : 2000-07-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-05-10
DMF Number : 16951
Submission : 2003-11-03
Status : Active
Type : II
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A NCGC00024675-06 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00024675-06, including repackagers and relabelers. The FDA regulates NCGC00024675-06 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00024675-06 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A NCGC00024675-06 supplier is an individual or a company that provides NCGC00024675-06 active pharmaceutical ingredient (API) or NCGC00024675-06 finished formulations upon request. The NCGC00024675-06 suppliers may include NCGC00024675-06 API manufacturers, exporters, distributors and traders.
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A NCGC00024675-06 DMF (Drug Master File) is a document detailing the whole manufacturing process of NCGC00024675-06 active pharmaceutical ingredient (API) in detail. Different forms of NCGC00024675-06 DMFs exist exist since differing nations have different regulations, such as NCGC00024675-06 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NCGC00024675-06 DMF submitted to regulatory agencies in the US is known as a USDMF. NCGC00024675-06 USDMF includes data on NCGC00024675-06's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NCGC00024675-06 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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