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Rizatriptan Benzoate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 21 USDMF, 12 CEP/COS, 4 JDMF, 16 EU WC, 14 NDC API, 20 Listed Suppliers, $ API Reference Price

32 API Suppliers
21 USDMF
12 CEP/COS
4 JDMF
16 EU WC
14 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

13 Intermediates Suppliers

13 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

299 FDF Dossiers, 55 FDA Orange Book, 160 Europe, 38 Canada, 6 Australia, 15 South Africa, 25 Listed Dossiers

299 FDF Dossiers
55 FDA Orange Book
160 Europe
38 Canada
6 Australia
15 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE, TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
FILM;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 6 Rochem International Inc, 18 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Bioplus Life Sciences, 11 Corel Pharma Chem, 6 DFE Pharma, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 6 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
1 Evonik
6 Rochem International Inc
18 SPI Pharma
5 DKSH
1 Pharm-RX Chemical
6 Faran Shimi Pharmaceutical
4 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
16 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
3 Actylis
2 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
6 BASF
1 Bioplus Life Sciences
11 Corel Pharma Chem
6 DFE Pharma
9 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
31 Kerry
4 Kima Chemical
6 Lonza Capsugel
13 Microlex e.U
1 NEWEDGE Overseas
2 Novo Excipients
4 Pharmatrans-Sanaq
6 Pluviaendo
6 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
29 Roquette
7 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
3 The Dow Chemical Company
1 Ulanqab Kema New Material
4 Vasa Pharmachem
2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 44 Disintegrants & Superdisintegrants, 42 Direct Compression, 27 Taste Masking, 23 Controlled & Modified Release, 23 Granulation, 23 Thickeners and Stabilizers, 22 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 17 Film Formers & Plasticizers, 17 Co-Processed Excipients, 9 Parenteral, 9 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Solubilizers, 4 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents, 2 Topical, 1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 160 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
160 Finished Drug Prices

MARKET PLACE

8 APIs

marketPlace
8 APIs

PATENTS & EXCLUSIVITIES

1 US Patents, 4 Health Canada Patents

patents
1 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 2 Others

otherSolutions
2 EDQM
2 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 8,320

MARKET PLACE

API

FDF

13INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

299

FDF Dossiers

FDA Orange Book

160

Europe

Canada

Australia

South Africa

Listed Dossiers

15DRUGS 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)

21,266,376

Annual Reports (USD Million)

Finished Drug Prices

265 RELATED EXCIPIENT COMPANIES

430EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 145202-66-0, Maxalt, Rizatriptan (benzoate), Maxalt-mlt, Mk 462, Mk-462

Molecular Formula

C₂₂H₂₅N₅O₂

Molecular Weight

391.5 g/mol

InChI Key

JPRXYLQNJJVCMZ-UHFFFAOYSA-N

FDA UNII

WR978S7QHH

Rizatriptan Benzoate is the benzoate salt form of rizatriptan, a member of the triptan class agents with anti-migraine property. Rizatriptan benzoate selectively binds to and activates serotonin (5-HT) 1B receptors expressed in intracranial arteries, and to 5-HT 1D receptors located on peripheral trigeminal sensory nerve terminals in the meninges and central terminals in brain stem sensory nuclei. Receptor binding results in constriction of cranial vessels and inhibition of nociceptive transmission, thereby providing relief of migraine headaches. Rizatriptan benzoate may also relief migraine headaches by inhibition of pro-inflammatory neuropeptide release.

1 2D Structure

Rizatriptan Benzoate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

benzoic acid;N,N-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethanamine

2.1.2 InChI

InChI=1S/C15H19N5.C7H6O2/c1-19(2)6-5-13-8-17-15-4-3-12(7-14(13)15)9-20-11-16-10-18-20;8-7(9)6-4-2-1-3-5-6/h3-4,7-8,10-11,17H,5-6,9H2,1-2H3;1-5H,(H,8,9)

2.1.3 InChI Key

JPRXYLQNJJVCMZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN(C)CCC1=CNC2=C1C=C(C=C2)CN3C=NC=N3.C1=CC=C(C=C1)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

WR978S7QHH

2.3 Synonyms

2.3.1 MeSH Synonyms

1. L 705,126

2. L 705126

3. L-705,126

4. L-705126

5. Maxalt

6. Mk 0462

7. Mk 462

8. Mk-0462

9. Mk-462

10. N,n-dimethyl-2-(5-(1,2,4-triazol-1-ylmethyl)-1h-indole-3-yl)ethylamine

11. Rizatriptan

2.3.2 Depositor-Supplied Synonyms

1. 145202-66-0

2. Maxalt

3. Rizatriptan (benzoate)

4. Maxalt-mlt

5. Mk 462

6. Mk-462

7. Mk-0462

8. 2-(5-((1h-1,2,4-triazol-1-yl)methyl)-1h-indol-3-yl)-n,n-dimethylethanamine Benzoate

9. Nsc-758919

10. Wr978s7qhh

11. Rizatriptan Benzoate (maxalt)

12. N,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethylamine Benzoate

13. 3-(2-(dimethylamino)ethyl)-5-(1h-1,2,4-triazol-1-ylmethyl)indole Monobenzoate

14. 1h-indole-3-ethanamine, N,n-dimethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-, Monobenzoate

15. 2-(5-((1h-1,2,4-triazol-1-yl)methyl)-1h-indol-3-yl)-n,n-dimethylethan-1-amine Benzoate

16. Benzoic Acid;n,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethanamine

17. Rizatriptanbenzoate

18. N,n-dimethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1h-indole-3-ethanamine Benzoate

19. Rizatriptan Benzoate [usan]

20. Mk 0462

21. Unii-wr978s7qhh

22. L 705126

23. L 705,126

24. L-705,126

25. Rizatriptan Benzoate [usan:usp]

26. Rizatrimptan Benzoate

27. Rizatriptane Benzoate

28. Rizatriptan, Benzoate

29. Mk-462 Benzoate

30. Schembl41226

31. Mls001424197

32. Chebi:8875

33. Rizatriptan Benzoate Salt

34. Chembl1201032

35. Rizatriptan Benzoate (jan/usp)

36. Amy8935

37. Dtxsid20162937

38. Rhb-103

39. Rizatriptan Benzoate [mi]

40. Hms2051b16

41. Hms2093k08

42. Hms2235m18

43. Hms3369i15

44. Hms3393b16

45. Hms3655k09

46. Hms3715d08

47. Hms3884k21

48. Pharmakon1600-01505189

49. Rizatriptan Benzoate [jan]

50. Act04340

51. Bcp02149

52. Hy-b0206

53. Int-0008

54. Rizatriptan Benzoate [vandf]

55. Ac-734

56. Mfcd00866224

57. Nsc758919

58. Rizatriptan Benzoate [mart.]

59. Rizatriptan Benzoate [usp-rs]

60. Rizatriptan Benzoate [who-dd]

61. Akos015855933

62. Ab07521

63. Ccg-101039

64. Ks-1189

65. Nc00289

66. Nsc 758919

67. Rizatriptan Benzoate [orange Book]

68. Smr000525252

69. Rizatriptan Benzoate [ep Monograph]

70. Db-015783

71. Rizatriptan Benzoate [usp Monograph]

72. Rizatriptan Benzoate Salt, >=98% (hplc)

73. Ft-0631171

74. R0107

75. R0181

76. S1607

77. Sw197669-2

78. D00675

79. 202r660

80. A808337

81. Sr-01000763588

82. J-008071

83. J-524222

84. Sr-01000763588-3

85. Q27292788

86. Rizatriptan Benzoate, European Pharmacopoeia (ep) Reference Standard

87. Rizatriptan Benzoate, United States Pharmacopeia (usp) Reference Standard

88. Dimethyl-[2-(5-[1,2,4]triazol-1-ylmethyl-1h-indol-3-yl)-ethyl]-amine Benzoate

89. N,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethanamine Benzoate

90. Rizatriptan For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₅N₅O₂
Molecular Weight	391.5 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	6
Exact Mass	391.20082506 g/mol
Monoisotopic Mass	391.20082506 g/mol
Topological Polar Surface Area	87 Å²
Heavy Atom Count	29
Formal Charge	0
Complexity	412
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
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 4
Drug Name	Maxalt
PubMed Health	Rizatriptan (By mouth)
Drug Classes	Antimigraine
Drug Label	MAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
Active Ingredient	Rizatriptan benzoate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 10mg base
Market Status	Prescription
Company	Merck

2 of 4
Drug Name	Rizatriptan benzoate
Drug Label	MAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
Active Ingredient	Rizatriptan benzoate
Dosage Form	Tablet; Tablet, orally disintegrating
Route	Oral
Strength	eq 5mg base; eq 10mg base
Market Status	Prescription
Company	Mylan Pharms; Apotex; Aurobindo Pharma; Natco Pharma; Sandoz; Invagen Pharms; Cipla; Sun Pharma Global; Glenmark Generics; Emcure Pharms; Teva Pharms; Macleods Pharms

3 of 4
Drug Name	Maxalt
PubMed Health	Rizatriptan (By mouth)
Drug Classes	Antimigraine
Drug Label	MAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
Active Ingredient	Rizatriptan benzoate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 10mg base
Market Status	Prescription
Company	Merck

4 of 4
Drug Name	Rizatriptan benzoate
Drug Label	MAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
Active Ingredient	Rizatriptan benzoate
Dosage Form	Tablet; Tablet, orally disintegrating
Route	Oral
Strength	eq 5mg base; eq 10mg base
Market Status	Prescription
Company	Mylan Pharms; Apotex; Aurobindo Pharma; Natco Pharma; Sandoz; Invagen Pharms; Cipla; Sun Pharma Global; Glenmark Generics; Emcure Pharms; Teva Pharms; Macleods Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Serotonin Receptor Agonists

Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin 1d Receptor Agonists [MoA]; Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]; Serotonin 1b Receptor Agonists [MoA]

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API Reference Price

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DOSAGE - FILM;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 205394

DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 20864

DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20864

DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 20865

DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20865

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ABOUT THIS PAGE

Rizatriptan Benzoate Manufacturers

A Rizatriptan Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rizatriptan Benzoate, including repackagers and relabelers. The FDA regulates Rizatriptan Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rizatriptan Benzoate 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 Rizatriptan Benzoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Rizatriptan Benzoate Suppliers

A Rizatriptan Benzoate supplier is an individual or a company that provides Rizatriptan Benzoate active pharmaceutical ingredient (API) or Rizatriptan Benzoate finished formulations upon request. The Rizatriptan Benzoate suppliers may include Rizatriptan Benzoate API manufacturers, exporters, distributors and traders.

click here to find a list of Rizatriptan Benzoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Rizatriptan Benzoate USDMF

A Rizatriptan Benzoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rizatriptan Benzoate active pharmaceutical ingredient (API) in detail. Different forms of Rizatriptan Benzoate DMFs exist exist since differing nations have different regulations, such as Rizatriptan Benzoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Rizatriptan Benzoate DMF submitted to regulatory agencies in the US is known as a USDMF. Rizatriptan Benzoate USDMF includes data on Rizatriptan Benzoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rizatriptan Benzoate USDMF is kept confidential to protect the manufacturer’s intellectual property.

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Rizatriptan Benzoate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Rizatriptan Benzoate Drug Master File in Japan (Rizatriptan Benzoate JDMF) empowers Rizatriptan Benzoate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Rizatriptan Benzoate JDMF during the approval evaluation for pharmaceutical products. At the time of Rizatriptan Benzoate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Rizatriptan Benzoate CEP

A Rizatriptan Benzoate CEP of the European Pharmacopoeia monograph is often referred to as a Rizatriptan Benzoate Certificate of Suitability (COS). The purpose of a Rizatriptan Benzoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rizatriptan Benzoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rizatriptan Benzoate to their clients by showing that a Rizatriptan Benzoate CEP has been issued for it. The manufacturer submits a Rizatriptan Benzoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rizatriptan Benzoate CEP holder for the record. Additionally, the data presented in the Rizatriptan Benzoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rizatriptan Benzoate DMF.

A Rizatriptan Benzoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rizatriptan Benzoate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Rizatriptan Benzoate suppliers with CEP (COS) on PharmaCompass.

Rizatriptan Benzoate WC

A Rizatriptan Benzoate written confirmation (Rizatriptan Benzoate WC) is an official document issued by a regulatory agency to a Rizatriptan Benzoate manufacturer, verifying that the manufacturing facility of a Rizatriptan Benzoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rizatriptan Benzoate APIs or Rizatriptan Benzoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Rizatriptan Benzoate WC (written confirmation) as part of the regulatory process.

click here to find a list of Rizatriptan Benzoate suppliers with Written Confirmation (WC) on PharmaCompass.

Rizatriptan Benzoate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Rizatriptan Benzoate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Rizatriptan Benzoate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Rizatriptan Benzoate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Rizatriptan Benzoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rizatriptan Benzoate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Rizatriptan Benzoate suppliers with NDC on PharmaCompass.

Rizatriptan Benzoate GMP

Rizatriptan Benzoate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Rizatriptan Benzoate CoA

A Rizatriptan Benzoate CoA (Certificate of Analysis) is a formal document that attests to Rizatriptan Benzoate's compliance with Rizatriptan Benzoate specifications and serves as a tool for batch-level quality control.

Rizatriptan Benzoate CoA mostly includes findings from lab analyses of a specific batch. For each Rizatriptan Benzoate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Rizatriptan Benzoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Rizatriptan Benzoate EP), Rizatriptan Benzoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rizatriptan Benzoate USP).

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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

21 USDMF

12 CEP/COS

4 JDMF

16 EU WC

14 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

13 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

299 FDF Dossiers

55 FDA Orange Book

160 Europe

38 Canada

6 Australia

15 South Africa

25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders

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TABLET;ORAL - EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons