Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1ChemWerth Inc
03 1Veranova
04 1Aurobindo Pharma Limited
05 1Biddle Sawyer Corporation
06 1Emcure Pharmaceuticals
07 1Industriale Chimica
08 1Intas Pharmaceuticals
09 1Kaken Pharmaceuticals
10 1MSN Laboratories
11 1Sigmapharm Laboratories, LLC
12 1Sun Pharmaceutical Industries Limited
13 1Viatris
01 14245.C (MILLED) [DOFETILIDE]
02 1AMORPHOUS DOFETILIDE
03 1DOFETILIDE
04 8DOFETILIDE USP
05 1DOFETILIDE USP, POLYMORPH P162B
06 1KP-470
01 1Czech Republic
02 5India
03 1Italy
04 1Japan
05 5U.S.A
01 13Active
01 12Complete
02 1Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-06
Pay. Date : 2017-10-02
DMF Number : 31858
Submission : 2017-07-24
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-08-11
DMF Number : 30718
Submission : 2017-08-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-18
Pay. Date : 2014-02-12
DMF Number : 27816
Submission : 2014-02-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-31
DMF Number : 30560
Submission : 2016-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-07-06
DMF Number : 30508
Submission : 2016-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-06
Pay. Date : 2015-12-01
DMF Number : 30042
Submission : 2015-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30794
Submission : 2018-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-22
Pay. Date : 2014-06-09
DMF Number : 28301
Submission : 2014-06-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-23
Pay. Date : 2016-09-30
DMF Number : 31026
Submission : 2016-11-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-09-18
DMF Number : 29722
Submission : 2015-10-07
Status : Active
Type : II
A Dofetilide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dofetilide, including repackagers and relabelers. The FDA regulates Dofetilide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dofetilide 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 Dofetilide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dofetilide supplier is an individual or a company that provides Dofetilide active pharmaceutical ingredient (API) or Dofetilide finished formulations upon request. The Dofetilide suppliers may include Dofetilide API manufacturers, exporters, distributors and traders.
click here to find a list of Dofetilide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dofetilide DMF (Drug Master File) is a document detailing the whole manufacturing process of Dofetilide active pharmaceutical ingredient (API) in detail. Different forms of Dofetilide DMFs exist exist since differing nations have different regulations, such as Dofetilide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dofetilide DMF submitted to regulatory agencies in the US is known as a USDMF. Dofetilide USDMF includes data on Dofetilide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dofetilide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dofetilide suppliers with USDMF on PharmaCompass.
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