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List of Drug Master Files (DMF) of Dofetilide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 FARMAK, a.s (1)

02 ChemWerth Inc (1)

03 Veranova (1)

04 Sun Pharmaceutical Industries Limited (1)

05 Aurobindo Pharma Limited (1)

06 Biddle Sawyer Corporation (1)

07 Emcure Pharmaceuticals (1)

08 Industriale Chimica s.r.l. (1)

09 Intas Pharmaceuticals (1)

10 Kaken Pharmaceuticals (1)

11 MSN Laboratories (1)

12 Sigmapharm Laboratories, LLC (1)

13 Viatris (1)

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01 4245.C (MILLED) [DOFETILIDE] (1)

02 AMORPHOUS DOFETILIDE (1)

03 DOFETILIDE (1)

04 DOFETILIDE USP (8)

05 DOFETILIDE USP, POLYMORPH P162B (1)

06 KP-470 (1)

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01 Czech Republic (1)

02 India (5)

03 Italy (1)

04 Japan (1)

05 U.S.A (5)

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01 Active (13)

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01 Complete (12)

02 Blank (1)

URL Supplier Web Content
31026
Active
2016-11-19
Complete
2016-12-23
2016-09-30
II
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URL Supplier Web Content
30560
Active
2016-06-01
Complete
2016-07-19
2016-05-31
II
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URL Supplier Web Content
30508
Active
2016-06-29
Complete
2016-09-20
2016-07-06
II
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URL Supplier Web Content
30042
Active
2015-12-17
Complete
2016-04-06
2015-12-01
II
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URL Supplier Web Content
30794
Active
2018-05-30
N/A
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URL Supplier Web Content
28301
Active
2014-06-05
Complete
2014-08-22
2014-06-09
II
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URL Supplier Web Content
29722
Active
2015-10-07
Complete
2015-12-23
2015-09-18
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Looking for 115256-11-6 / Dofetilide API manufacturers, exporters & distributors?

Dofetilide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dofetilide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dofetilide manufacturer or Dofetilide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dofetilide manufacturer or Dofetilide supplier.

PharmaCompass also assists you with knowing the Dofetilide API Price utilized in the formulation of products. Dofetilide API Price is not always fixed or binding as the Dofetilide Price is obtained through a variety of data sources. The Dofetilide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dofetilide

Synonyms

115256-11-6, Tikosyn, Dofetilida, Dofetilidum, Dofetilidum [inn-latin], Dofetilida [inn-spanish]

Cas Number

115256-11-6

Unique Ingredient Identifier (UNII)

R4Z9X1N2ND

About Dofetilide

Dofetilide is a sulfonamide class III antiarrhythmic agent and potassium channel blocker. Dofetilide selectively blocks cardiac ion channels of the rapid component of the delayed rectifier potassium current Ikr. This antiarrhythmic agent prolongs cardiac action potential duration and effective refractory period due to delayed repolarization without affecting conduction velocity. This results in a normal sinus rhythm. Dofetilide is used in the treatment of atrial fibrillation and flutter.

Dofetilide Manufacturers

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.

Dofetilide Suppliers

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.

Dofetilide USDMF

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.

Dofetilide Manufacturers | Traders | Suppliers

Dofetilide Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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