Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 13M Company
03 1Amsa Spa
04 1Aurobindo Pharma Limited
05 1Emcure Pharmaceuticals
06 1MSN Laboratories
07 3Maprimed
08 1Omsav Pharma Research
09 1Solara Active Pharma Sciences
10 2Unimark Remedies Limited
01 1FLECAINIDE ACETATE
02 1FLECAINIDE ACETATE PROCESS I (CODE 50064)
03 1FLECAINIDE ACETATE PROCESS II (CODE 50856)
04 1FLECAINIDE ACETATE PROCESS III (CODE 50970)
05 7FLECAINIDE ACETATE USP
06 1FLECAINIDE ACETATE USP (PROCESS B)
07 1MANUFACTURE OF FLECAINIDE ACETATE
01 3Argentina
02 1France
03 7India
04 1Italy
05 1U.S.A
01 10Active
02 3Inactive
01 6Complete
02 7Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15244
Submission : 2001-01-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14749
Submission : 2000-02-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-13
Pay. Date : 2017-05-18
DMF Number : 31757
Submission : 2017-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2014-02-05
DMF Number : 27859
Submission : 2014-01-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-22
Pay. Date : 2014-04-28
DMF Number : 28158
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10688
Submission : 1994-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-26
Pay. Date : 2023-08-29
DMF Number : 35760
Submission : 2021-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33666
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-02-01
DMF Number : 23192
Submission : 2009-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19272
Submission : 2006-03-23
Status : Active
Type : II
A Flecainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flecainide, including repackagers and relabelers. The FDA regulates Flecainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flecainide 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 Flecainide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flecainide supplier is an individual or a company that provides Flecainide active pharmaceutical ingredient (API) or Flecainide finished formulations upon request. The Flecainide suppliers may include Flecainide API manufacturers, exporters, distributors and traders.
click here to find a list of Flecainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flecainide DMF (Drug Master File) is a document detailing the whole manufacturing process of Flecainide active pharmaceutical ingredient (API) in detail. Different forms of Flecainide DMFs exist exist since differing nations have different regulations, such as Flecainide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flecainide DMF submitted to regulatory agencies in the US is known as a USDMF. Flecainide USDMF includes data on Flecainide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flecainide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flecainide suppliers with USDMF on PharmaCompass.
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