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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 13 USDMF, 13 CEP/COS, 1 JDMF, 6 EU WC, 1 KDMF, 8 NDC API, 14 Listed Suppliers, $ API Reference Price

26 API Suppliers
13 USDMF
13 CEP/COS
1 JDMF
6 EU WC
1 KDMF
8 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

125 FDF Dossiers, 31 FDA Orange Book, 66 Europe, 12 Canada, 8 Australia, 4 South Africa, 4 Listed Dossiers

125 FDF Dossiers
31 FDA Orange Book
66 Europe
12 Canada
8 Australia
4 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 2 DKSH, 3 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 11 Gangwal Healthcare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 4 Kerry, 9 Microlex e.U, 1 NEWEDGE Overseas, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 18 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

37 Fillers, Diluents & Binders, 22 Direct Compression, 21 Lubricants & Glidants, 21 Disintegrants & Superdisintegrants, 14 Thickeners and Stabilizers, 11 Co-Processed Excipients, 9 Granulation, 8 Coating Systems & Additives, 7 Chewable & Orodispersible Aids, 5 Film Formers & Plasticizers, 5 Taste Masking, 5 Controlled & Modified Release, 3 Emulsifying Agents, 2 Rheology Modifiers, 1 API Stability Enhancers, 1 Topical

excipientsByApplications
37 Fillers, Diluents & Binders
22 Direct Compression
21 Lubricants & Glidants
21 Disintegrants & Superdisintegrants
14 Thickeners and Stabilizers
11 Co-Processed Excipients
9 Granulation
8 Coating Systems & Additives
7 Chewable & Orodispersible Aids
5 Film Formers & Plasticizers
5 Taste Masking
5 Controlled & Modified Release
3 Emulsifying Agents
2 Rheology Modifiers
1 API Stability Enhancers
1 Topical

DIGITAL CONTENT

6 NEWS #PharmaBuzz

media
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 53 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
53 Finished Drug Prices

MARKET PLACE

15 APIs, 4 FDF Dossiers

marketPlace
15 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM , 2 USP , 5 Others

otherSolutions
4 EDQM
2 USP
5 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 349

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

125

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

77,898,698

Annual Reports (USD Million)

Finished Drug Prices

102 RELATED EXCIPIENT COMPANIES

172EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 54143-56-5, Flecainide (acetate), Tambocor, R-818, Flecainide monoacetate, Flecainide acetate salt

Molecular Formula

C₁₉H₂₄F₆N₂O₅

Molecular Weight

474.4 g/mol

InChI Key

RKXNZRPQSOPPRN-UHFFFAOYSA-N

FDA UNII

M8U465Q1WQ

A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.

1 2D Structure

Flecainide

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;N-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide

2.1.2 InChI

InChI=1S/C17H20F6N2O3.C2H4O2/c18-16(19,20)9-27-12-4-5-14(28-10-17(21,22)23)13(7-12)15(26)25-8-11-3-1-2-6-24-11;1-2(3)4/h4-5,7,11,24H,1-3,6,8-10H2,(H,25,26);1H3,(H,3,4)

2.1.3 InChI Key

RKXNZRPQSOPPRN-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(=O)O.C1CCNC(C1)CNC(=O)C2=C(C=CC(=C2)OCC(F)(F)F)OCC(F)(F)F

2.2 Other Identifiers

2.2.1 UNII

M8U465Q1WQ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Apocard

2. Flcane

3. Flecadura

4. Flecainid Isis

5. Flecainid-isis

6. Flecainide

7. Flecainide Monoacetate

8. Flecainide Monoacetate, (+-)-isomer

9. Flecainide Monoacetate, (r)-isomer

10. Flecainide Monoacetate, (s)-isomer

11. Flecainide, (r)-isomer

12. Flecainide, (s)-isomer

13. Flecainide, 5-ho-n-(6-oxo)-derivative

14. Flecainide, 5-ho-n-(6-oxo)-derivative, (+-)-isomer

15. Flecatab

16. R818

17. Tambocor

2.3.2 Depositor-Supplied Synonyms

1. 54143-56-5

2. Flecainide (acetate)

3. Tambocor

4. R-818

5. Flecainide Monoacetate

6. Flecainide Acetate Salt

7. R 818

8. 54143-56-5 (acetate)

9. N-(2-piperidylmethyl)-2,5-bis-(2,2,2-trifluoroethoxy)benzamide Acetate

10. N-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide Monoacetate

11. Mls000069675

12. Chebi:5091

13. M8u465q1wq

14. Apocard

15. Benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-, Monoacetate

16. Benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-,monoacetate

17. N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide Monoacetate

18. Smr000058451

19. Acetic Acid;n-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide

20. N-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide Acetate

21. Sr-01000000172

22. Einecs 258-997-5

23. Mfcd00214290

24. Unii-m8u465q1wq

25. Flecainidacetat

26. Tambocor (tn)

27. Flecainide Acetate [usan:usp:jan]

28. N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide Monoacetate

29. Dsstox_cid_626

30. Opera_id_1587

31. 2,5-bis-(2,2,2-trifluoroethoxy)-n-(2-piperidinylmethyl)benzamide Acetate

32. Cas-54143-56-5

33. Dsstox_rid_75700

34. Dsstox_gsid_20626

35. Mls001148177

36. Mls002222300

37. Schembl121583

38. Chembl1200822

39. Dtxsid8020626

40. Flecainide Acetate [jan]

41. Flecainide Acetate (jp17/usp)

42. Flecainide For System Suitability

43. Flecainide Acetate [usan]

44. Flecainide Acetate [vandf]

45. Hms1570c12

46. Hms2097c12

47. Hms2231e15

48. Hms3259f11

49. Hms3267n04

50. Hms3369m07

51. Hms3412d09

52. Hms3676d09

53. Hms3714c12

54. Flecainide Acetate [mart.]

55. 11a-hydroxyepoxyprogesterone

56. Bcp17825

57. Flecainide Acetate [usp-rs]

58. Flecainide Acetate [who-dd]

59. Tox21_200208

60. Akos015889993

61. N-(piperidin-2-ylmethyl)-2,5-bis[(2,2,2-trifluoroethyl)oxy]benzamide Acetate

62. Ccg-220735

63. Cs-1400

64. Nc00641

65. Sb19142

66. Flecainide Acetate [ep Impurity]

67. Flecainide Acetate [orange Book]

68. Flecainide Acetate [ep Monograph]

69. Flecainide Acetate [usp Impurity]

70. Ncgc00093934-01

71. Ncgc00093934-02

72. Ncgc00257762-01

73. As-11702

74. Flecainide Acetate [usp Monograph]

75. Hy-17429

76. Db-052497

77. Eu-0100546

78. Ft-0630667

79. En300-51344

80. D00638

81. E-0735

82. F 6777

83. 143f565

84. Sr-01000000172-2

85. Sr-01000000172-4

86. Sr-01000000172-5

87. Sr-01000000172-7

88. Q27089351

89. Flecainide Acetate, British Pharmacopoeia (bp) Reference Standard

90. Flecainide Acetate, European Pharmacopoeia (ep) Reference Standard

91. 2,5-bis(2,2,2-trifluoroethoxy)-n-(2-piperidylmethyl)benzamide Acetate

92. Flecainide Acetate, United States Pharmacopeia (usp) Reference Standard

93. 2-({[2,5-bis(2,2,2-trifluoroethoxy)benzoyl]amino}methyl)piperidinium Acetate

94. Flecainide For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₄F₆N₂O₅
Molecular Weight	474.4 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	7
Exact Mass	474.15894084 g/mol
Monoisotopic Mass	474.15894084 g/mol
Topological Polar Surface Area	96.9 Å²
Heavy Atom Count	32
Formal Charge	0
Complexity	531
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Flecainide acetate
Drug Label	Flecainide acetate is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis (2,2,2-trifluoroethoxy)-monoacetate. Its molecular formula is C17H20F6N2...
Active Ingredient	Flecainide acetate
Dosage Form	Tablet
Route	Oral
Strength	100mg; 50mg; 150mg
Market Status	Prescription
Company	Ranbaxy; Amneal Pharm; Roxane; Barr

2 of 2
Drug Name	Flecainide acetate
Drug Label	Flecainide acetate is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis (2,2,2-trifluoroethoxy)-monoacetate. Its molecular formula is C17H20F6N2...
Active Ingredient	Flecainide acetate
Dosage Form	Tablet
Route	Oral
Strength	100mg; 50mg; 150mg
Market Status	Prescription
Company	Ranbaxy; Amneal Pharm; Roxane; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Arrhythmia Agents

Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

Voltage-Gated Sodium Channel Blockers

A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Antiarrhythmic [EPC]

API SUPPLIERS

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Listed Suppliers

01

LGM Pharma

U.S.A

AES 2024

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

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Digital Content

Flecainide

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

02

Metrochem API Private Limited

India

AES 2024

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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Flecainide

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

03

HRV Global Life Sciences

India

CPHI Middle east

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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Flecainide

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

04

Artis Biotech

India

AES 2024

Not Confirmed

05

AXYNTIS Group

France

AES 2024

Not Confirmed

06

CHEMO

Spain

AES 2024

Not Confirmed

07

CHEMO

AES 2024

Not Confirmed

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API Reference Price

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R.L.","customerCountry":"MEXICO","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"765","totalValueFC":"1329.4","currency":"USD","unitRateINR":49500,"date":"19-Nov-2021","totalValueINR":"99000","totalValueInUsd":"1329.4","indian_port":"AHMEDABAD AIR","hs_no":"29333990","bill_no":"6105920","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640543400,"product":"FLECAINIDE ACETATE","address":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO.4 WOMENS,S CO-OP. 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PELLI 17, P.O . 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PELLI 17 P.O BOX CH-6901 LUGANO SWITZERLAND","customerAddress":"MUMBAI CENTRAL,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

ANGITA PHARMA INC.

Canada

Israel

Antibody Engineering

Not Confirmed

09

Country

Antibody Engineering

Not Confirmed

10

Country

Antibody Engineering

Not Confirmed

Only 10 entries up to this point, click to access all

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FDA Orange Book

01

ALVOGEN

U.S.A

U.S.A

Bangladesh

Antibody Engineering

Not Confirmed

08

CHARTWELL

U.S.A

Antibody Engineering

Not Confirmed

09

SUN PHARM INDS LTD

India

Antibody Engineering

Not Confirmed

10

SUN PHARM INDS LTD

India

Antibody Engineering

Not Confirmed

NORA PHARMA INC

Canada

Antibody Engineering

Not Confirmed

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Australia

01

Alphapharm Pty Ltd

Australia

Singapore

Switzerland

Antibody Engineering

Singapore

Antibody Engineering

Spain

Antibody Engineering

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18830

DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18830

DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18830

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