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Cyclobenzaprine

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 16 USDMF, 1 JDMF, 7 EU WC, 22 NDC API, 18 Listed Suppliers, $ API Reference Price

32 API Suppliers
16 USDMF
1 JDMF
7 EU WC
22 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

43 Drugs in Development

43 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers, 56 FDA Orange Book, 1 Europe, 11 Canada, 18 Listed Dossiers

86 FDF Dossiers
56 FDA Orange Book
1 Europe
11 Canada
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG

drugProductComposition
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 9 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 11 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 8 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 16 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 33 Direct Compression, 32 Controlled & Modified Release, 30 Thickeners and Stabilizers, 22 Granulation, 20 Disintegrants & Superdisintegrants, 20 Topical, 18 Solubilizers, 16 Lubricants & Glidants, 16 Film Formers & Plasticizers, 16 Co-Processed Excipients, 13 Parenteral, 12 Taste Masking, 9 Empty Capsules, 9 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents

DIGITAL CONTENT

36 NEWS #PharmaBuzz

media
36 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 8 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

10 APIs, 1 FDF Dossiers

marketPlace
10 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 USP , 5 Others

otherSolutions
3 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)

$ 214

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

43DRUGS 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)

89,746,236

Annual Reports (USD Million)

Finished Drug Prices

250 RELATED EXCIPIENT COMPANIES

423EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 6202-23-9, Cyclobenzaprine hcl, Flexeril, Flexiban, Amrix, Lisseril

Molecular Formula

C₂₀H₂₂ClN

Molecular Weight

311.8 g/mol

InChI Key

VXEAYBOGHINOKW-UHFFFAOYSA-N

FDA UNII

0VE05JYS2P

Cyclobenzaprine Hydrochloride is a centrally acting muscle relaxant, chemically similar to amitriptyline hydrochloride with antidepressant activity. The exact mechanism of action of cyclobenzaprine hydrochloride has not been fully determined. However, it primarily acts at the brain stem to reduce tonic somatic motor activity, influencing both gamma and alpha motor neurons. This leads to a reduction in muscle spasms.

1 2D Structure

Cyclobenzaprine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)propan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C20H21N.ClH/c1-21(2)15-7-12-20-18-10-5-3-8-16(18)13-14-17-9-4-6-11-19(17)20;/h3-6,8-14H,7,15H2,1-2H3;1H

2.1.3 InChI Key

VXEAYBOGHINOKW-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN(C)CCC=C1C2=CC=CC=C2C=CC3=CC=CC=C31.Cl

2.2 Other Identifiers

2.2.1 UNII

0VE05JYS2P

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cyclobenzaprine

2. Flexeril

3. Lisseril

2.3.2 Depositor-Supplied Synonyms

1. 6202-23-9

2. Cyclobenzaprine Hcl

3. Flexeril

4. Flexiban

5. Amrix

6. Lisseril

7. 3-(5h-dibenzo[a,d][7]annulen-5-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride

8. Cyclobenzaprine (hydrochloride)

9. Mk 130 Hydrochloride

10. Proheptatriene Hydrochloride

11. Mk130 Hydrochloride

12. Proheptatriene Monohydrochloride

13. Tnx-102

14. Nsc-78206

15. Nsc-169900

16. Nsc-173379

17. 0ve05jys2p

18. Chebi:3997

19. 5-(3-dimethylaminopropylidene)dibenzo[a,e]cycloheptatriene Hydrochloride

20. 1-propanamine, 3-(5h-dibenzo(a,d)cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride

21. N,n-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)propan-1-amine;hydrochloride

22. Cycloflex

23. Tensodox

24. Cloben

25. Cyben

26. Novo-cycloprine

27. Flexeril Hydrochloride

28. Dsstox_cid_25105

29. Dsstox_rid_80672

30. Dsstox_gsid_45105

31. Tabradol

32. Yurelax

33. Miosan

34. Mk-130 Hcl

35. Multi-relax

36. 10,11.delta.-amitriptyline Hydrochloride

37. Proheptatrien Monohydrochloride

38. Wln: L C676 Bhj B3n1&1 &gh

39. Nsc78206

40. 5h-dibenzo[a, N,n-dimethyl-, Hydrochloride

41. Nsc169900

42. Nsc173379

43. Sr-01000075761

44. Cyclobenzaprine Hydrochloride [usan]

45. Einecs 228-264-4

46. Cas-6202-23-9

47. Nsc 78206

48. Unii-0ve05jys2p

49. Nsc 169900

50. Nsc 173379

51. 10,11delta-amitriptyline Hydrochloride

52. 5h-dibenzo[a,.gamma.-propylamine, N,n-dimethyl-, Hydrochloride

53. N,d]cycloheptene-.delta.,5.gamma.-propylamine, Hydrochloride

54. Tonmya

55. 1-propanamine,d]cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride

56. N,d]cycloheptene-.delta.(sup5,.gamma.)-propylamine Hydrochloride

57. 5-[3-(dimethylamino)propylidene]-5h-dibenzo-[a,d]cycloheptene Hydrochloride

58. 3-(dibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-n,n-dimethylpropan-1-amine;hydrochloride

59. Flexeril (tn)

60. Prestwick_790

61. Mfcd00079039

62. Cyclobenzaprine Hydrochloride [usan:usp]

63. Nortriptyline Impurity E

64. 5-(3-dimethylaminopropylidene)-5h-dibenzo-(a,d)cycloheptene Hydrochloride

65. N,n-dimethyl-5h-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine Hydrochloride

66. Schembl41376

67. Mls002153815

68. Mk-130 Hydrochloride

69. Spectrum1503207

70. Amy502

71. Tnx-102 Sl

72. Chembl1200636

73. Dtxsid2045105

74. Tnx-105

75. Hms1569i12

76. Hms1922i11

77. Pharmakon1600-01503207

78. Act06294

79. Bcp21781

80. Cyclobenzaprine Hydrochloride (usp)

81. Eur-1002

82. Hy-b0740

83. Tox21_110040

84. Tox21_500303

85. Ccg-39312

86. Nsc758414

87. S4283

88. 3-(5h-dibenzo(a,d)cyclohepten-5-ylidene)propyl(dimethyl)ammonium Chloride

89. Akos015906329

90. Tox21_110040_1

91. Ac-1916

92. Bcp9000565

93. Lp00303

94. Nsc-758414

95. Sb19022

96. 5h-dibenzo(a,d)cycloheptene-delta(sup 5)-gamma-propylamine, N,n-dimethyl-, Hydrochloride

97. 5h-dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, N,n-dimethyl-, Hydrochloride

98. Ncgc00013841-01

99. Ncgc00013841-09

100. Ncgc00093752-01

101. Ncgc00093752-02

102. Ncgc00093752-03

103. Ncgc00093752-04

104. Ncgc00093752-05

105. Ncgc00095017-01

106. Ncgc00095017-02

107. Ncgc00095017-03

108. Ncgc00095017-04

109. Ncgc00260988-01

110. As-15745

111. Bc181325

112. Cyclobenzaprine Hydrochloride [mi]

113. Smr000326702

114. Cyclobenzaprine Hydrochloride [mart.]

115. Cyclobenzaprine Hydrochloride [vandf]

116. Eu-0100303

117. Ft-0603166

118. Sw196928-3

119. Cyclobenzaprine Hydrochloride [usp-rs]

120. Cyclobenzaprine Hydrochloride [who-dd]

121. A14255

122. C 4542

123. D00772

124. L10029

125. 202c239

126. A854881

127. Cyclobenzaprine Hydrochloride [orange Book]

128. Cyclobenzaprine Hydrochloride [usp Impurity]

129. Cyclobenzaprine Hydrochloride [usp Monograph]

130. Sr-01000075761-1

131. Sr-01000075761-6

132. W-105056

133. Q27106282

134. Cyclobenzaprine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

135. 3-(5h-dibenzo[a,d][7]annulen-5-ylidene)-n,n-dimethylpropan-1-aminehydrochloride

136. 3-(5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride

137. Cyclobenzaprine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

138. N,n-dimethyl-5h-dibenzo(a,d)cycloheptene-delta(5,gamma)-propylamine Hydrochloride

139. 3-(5h-dibenzo[a,d][7]annulen-5-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride (cyclobenzaprine Hydrochloride)

140. Cyclobenzaprine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

141. N,n-dimethyl-5h-dibenzo(a,d)cycloheptene-(sup .delta.5,.gamma.)-propylamine Hydrochloride

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₂ClN
Molecular Weight	311.8 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	3
Exact Mass	311.1440774 g/mol
Monoisotopic Mass	311.1440774 g/mol
Topological Polar Surface Area	3.2 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	365
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	Amrix
PubMed Health	Cyclobenzaprine (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in AMRIX extended-release capsules is cycloben...
Active Ingredient	Cyclobenzaprine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 15mg
Market Status	Prescription
Company	Ivax Intl

2 of 4
Drug Name	Cyclobenzaprine hydrochloride
Drug Label	Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217C, and a pKa of 8.47 at 25C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solven...
Active Ingredient	Cyclobenzaprine hydrochloride
Dosage Form	Tablet; Capsule, extended release
Route	oral; Oral
Strength	5mg; 7.5mg; 30mg; 10mg; 15mg
Market Status	Tentative Approval; Prescription
Company	Vintage Pharms; Twi Pharms; Ranbaxy; Mylan Pharms; Jubilant Cadista; Mutual Pharm; Kvk Tech; Actavis Labs Fl; Orit Labs; Aurobindo Pharma; Prosam Labs; Pliva; Invagen Pharms; Par Pharm

3 of 4
Drug Name	Amrix
PubMed Health	Cyclobenzaprine (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in AMRIX extended-release capsules is cycloben...
Active Ingredient	Cyclobenzaprine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 15mg
Market Status	Prescription
Company	Ivax Intl

4 of 4
Drug Name	Cyclobenzaprine hydrochloride
Drug Label	Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217C, and a pKa of 8.47 at 25C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solven...
Active Ingredient	Cyclobenzaprine hydrochloride
Dosage Form	Tablet; Capsule, extended release
Route	oral; Oral
Strength	5mg; 7.5mg; 30mg; 10mg; 15mg
Market Status	Tentative Approval; Prescription
Company	Vintage Pharms; Twi Pharms; Ranbaxy; Mylan Pharms; Jubilant Cadista; Mutual Pharm; Kvk Tech; Actavis Labs Fl; Orit Labs; Aurobindo Pharma; Prosam Labs; Pliva; Invagen Pharms; Par Pharm

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antidepressive Agents, Tricyclic

Substances that contain a fused three-ring moiety and are used in the treatment of depression. These drugs block the uptake of norepinephrine and serotonin into axon terminals and may block some subtypes of serotonin, adrenergic, and histamine receptors. However, the mechanism of their antidepressant effects is not clear because the therapeutic effects usually take weeks to develop and may reflect compensatory changes in the central nervous system. (See all compounds classified as Antidepressive Agents, Tricyclic.)

Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

Tranquilizing Agents

A traditional grouping of drugs said to have a soothing or calming effect on mood, thought, or behavior. Included here are the ANTI-ANXIETY AGENTS (minor tranquilizers), ANTIMANIC AGENTS, and the ANTIPSYCHOTIC AGENTS (major tranquilizers). These drugs act by different mechanisms and are used for different therapeutic purposes. (See all compounds classified as Tranquilizing Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Muscle Relaxant [EPC]; Centrally-mediated Muscle Relaxation [PE]

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Medichem S.A

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Contact Supplier

Spain

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USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

04

R L Fine Chem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

Not Confirmed

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USDMF

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JDMF

01

Dipharma Francis S. r. l.

Italy

BIO Partnering at JPM

Not Confirmed

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EU WC

01

Hetero Drugs

India

BIO Partnering at JPM

Not Confirmed

02

R L Fine Chem

India

BIO Partnering at JPM

Not Confirmed

03

R L Fine Chem

India

BIO Partnering at JPM

Not Confirmed

04

Vasudha Pharma Chem

India

BIO Partnering at JPM

Not Confirmed

05

Vasudha Pharma Chem

India

BIO Partnering at JPM

Not Confirmed

06

Viatris

U.S.A

BIO Partnering at JPM

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07

Viatris

U.S.A

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NDC API

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API Reference Price

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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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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 21777

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

USFDA APPLICATION NUMBER - 21777

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ABOUT THIS PAGE

Cyclobenzaprine Manufacturers

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

Cyclobenzaprine Suppliers

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

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

Cyclobenzaprine USDMF

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

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

click here to find a list of Cyclobenzaprine suppliers with USDMF on PharmaCompass.

Cyclobenzaprine 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 Cyclobenzaprine Drug Master File in Japan (Cyclobenzaprine JDMF) empowers Cyclobenzaprine 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 Cyclobenzaprine JDMF during the approval evaluation for pharmaceutical products. At the time of Cyclobenzaprine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cyclobenzaprine suppliers with JDMF on PharmaCompass.

Cyclobenzaprine WC

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

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

Cyclobenzaprine 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 Cyclobenzaprine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cyclobenzaprine 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 Cyclobenzaprine 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 Cyclobenzaprine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cyclobenzaprine NDC to their finished compounded human drug products, they may choose to do so.

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

Cyclobenzaprine GMP

Cyclobenzaprine 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 Cyclobenzaprine 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 Cyclobenzaprine GMP manufacturer or Cyclobenzaprine GMP API supplier for your needs.

Cyclobenzaprine CoA

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

Cyclobenzaprine CoA mostly includes findings from lab analyses of a specific batch. For each Cyclobenzaprine 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.

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

16 USDMF

1 JDMF

7 EU WC

22 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

43 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers

56 FDA Orange Book

1 Europe

11 Canada

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 15MG

CAPSULE, EXTENDED RELEASE;ORAL - 30MG

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EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders

56 Coating Systems & Additives

33 Direct Compression

32 Controlled & Modified Release

30 Thickeners and Stabilizers

22 Granulation

20 Disintegrants & Superdisintegrants

20 Topical

18 Solubilizers

16 Lubricants & Glidants

16 Film Formers & Plasticizers

16 Co-Processed Excipients