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Chemistry

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Also known as: 969-33-5, Cyproheptadine hcl, Periactin hydrochloride, Anarexol, Cipractin, Nuran
Molecular Formula
C21H22ClN
Molecular Weight
323.9  g/mol
InChI Key
ZPMVNZLARAEGHB-UHFFFAOYSA-N
FDA UNII
0S9323MCT0

Cyproheptadine Hydrochloride
A serotonin antagonist and a histamine H1 blocker used as antipruritic, appetite stimulant, antiallergic, and for the post-gastrectomy dumping syndrome, etc.
1 2D Structure

Cyproheptadine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine;hydrochloride
2.1.2 InChI
InChI=1S/C21H21N.ClH/c1-22-14-12-18(13-15-22)21-19-8-4-2-6-16(19)10-11-17-7-3-5-9-20(17)21;/h2-11H,12-15H2,1H3;1H
2.1.3 InChI Key
ZPMVNZLARAEGHB-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1CCC(=C2C3=CC=CC=C3C=CC4=CC=CC=C42)CC1.Cl
2.2 Other Identifiers
2.2.1 UNII
0S9323MCT0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Antergan

2. Cyproheptadine

3. Dihexazin

4. Periactin

5. Peritol

6. Viternum

2.3.2 Depositor-Supplied Synonyms

1. 969-33-5

2. Cyproheptadine Hcl

3. Periactin Hydrochloride

4. Anarexol

5. Cipractin

6. Nuran

7. Antegan

8. Peritol

9. Periactin Syrup

10. Component Of Dronactin

11. Cyproheptadine (hydrochloride)

12. Cyproheptadine Hydrochloride Anhydrous

13. Cyproheptadiene Hydrochloride

14. 41354-29-4

15. Nsc-169911

16. Cyproheptadine Hydrochloride Sesquihydrate

17. Cyproheptadine Hydrochloride (anhydrous)

18. Cpd000058431

19. Mls000028462

20. Chebi:59695

21. 0s9323mct0

22. 4-(5h-dibenzo[a,d][7]annulen-5-ylidene)-1-methylpiperidine Hydrochloride

23. Periactine

24. Nsc-759282

25. Smr000058431

26. 4-(5-dibenzo(a,e)cycloheptatrienylidene)piperidine Hydrochloride

27. Cyproheptadine (hydrochloride Sesquihydrate)

28. 1-methyl-4-(5-dibenzo(a,e)cycloheptatrienylidene)piperidine Hydrochloride

29. 1-methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine;hydrochloride

30. Periactinol (van)

31. Contrallerg

32. Kulinet

33. Kyliver

34. Sialotin

35. Vinorex

36. Istam

37. Periactinol Hydrochloride

38. Cyproheptadine Chlorhydrate

39. 4-(5h-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine Hydrochloride

40. 4-(5h-dibenzo[a,d]cyclohepten-5-ylidine)-methylpiperidine Hydrochloride

41. Cycloheptadine Hydrochloride

42. Cyproheptadine Hydrochloride Hydrate

43. Vufb3511

44. Sr-01000003077

45. Einecs 213-535-1

46. Nsc 169911

47. C21h21n.hcl

48. Unii-0s9323mct0

49. 4-(5-dibenzo[a,e]cycloheptatrienylidene)piperidine Hydrochloride

50. Ai3-26940

51. 1-methyl-4-(5-dibenzo[a,e]cycloheptatrienylidene)piperidine Hydrochloride

52. 4-(dibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-1-methylpiperidine;hydrochloride

53. Cycloheptadine Hcl

54. Prestwick_139

55. Opera_id_383

56. Cypoheptadine Hydrochloride

57. Cyproheptadine-hydrochloride

58. Piperidine, 4-(5h-dibenzo(a,d)cyclohepten-5-ylidene)-1-methyl-, Hydrochloride

59. Chembl1716

60. Schembl41842

61. Mls001077277

62. Mls001424281

63. Mls002222173

64. Regid_for_cid_13770

65. Cyproptadine Hydrochloride,(s)

66. Dtxsid5042586

67. Hy-b0366a

68. Hms1568e08

69. Hms3414j05

70. Hms3678j03

71. Pharmakon1600-01505973

72. Bcp34399

73. Cyproheptadine Hydrochloride (anh.)

74. Tox21_500246

75. Anhydrous Cyproheptadine Hydrochloride

76. Mfcd00012538

77. Nsc169911

78. Nsc759282

79. S2044

80. Akos015905305

81. Ccg-101144

82. Lp00246

83. Nc00394

84. Cyproheptadine Hydrochloride (periactin)

85. Ncgc00093708-01

86. Ncgc00093708-02

87. Ncgc00260931-01

88. Ac-15790

89. As-14697

90. Cyproheptadine Hydrochloride [who-dd]

91. Eu-0100246

92. Ft-0603147

93. Sw196450-4

94. C 6022

95. C77331

96. Wln: L C676 Byj Bu- Dt6n Dytj A1 &gh

97. Sr-01000003077-2

98. Sr-01000003077-4

99. Sr-01000003077-9

100. W-106308

101. Cyproheptadine Hydrochloride 100 Microg/ml In Methanol

102. Q27126856

103. Piperidine,d]cyclohepten-5-ylidene)-1-methyl-, Hydrochloride

104. 4-(5h-dibenzo [a,d]cyclohepten-5-ylidene)-1-methylpiperidine Hydrochloride

105. 4-(5h-dibenzo[a,d][7]annulen-5-ylidene)-1-methylpiperidinehydrochloride

106. 4-(5h-dibenzo[a,d]cyclohepten-5-yli Dine)-methylpiperidine Hydrochloride

107. 1-methyl-4-(2-tricyclo[9.4.0.0^{3,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine;hydrochloride

108. 1-methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13-heptaenylidene)piperidine Hydrochloride

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 323.9 g/mol
Molecular Formula C21H22ClN
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass323.1440774 g/mol
Monoisotopic Mass323.1440774 g/mol
Topological Polar Surface Area3.2 Ų
Heavy Atom Count23
Formal Charge0
Complexity423
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameCyproheptadine hydrochloride
PubMed HealthCyproheptadine Hydrochloride (By mouth)
Drug ClassesRespiratory Agent
Drug LabelCyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent.Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, spa...
Active IngredientCyproheptadine hydrochloride
Dosage FormTablet; Syrup
RouteOral
Strength4mg; 2mg/5ml
Market StatusPrescription
CompanyLyne; Corepharma; Stason Pharms; Ivax Sub Teva Pharms; Pharm Assoc; Par Pharm

2 of 2  
Drug NameCyproheptadine hydrochloride
PubMed HealthCyproheptadine Hydrochloride (By mouth)
Drug ClassesRespiratory Agent
Drug LabelCyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent.Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, spa...
Active IngredientCyproheptadine hydrochloride
Dosage FormTablet; Syrup
RouteOral
Strength4mg; 2mg/5ml
Market StatusPrescription
CompanyLyne; Corepharma; Stason Pharms; Ivax Sub Teva Pharms; Pharm Assoc; Par Pharm

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)


Serotonin Antagonists

Drugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or SEROTONIN RECEPTOR AGONISTS. (See all compounds classified as Serotonin Antagonists.)


Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)


Gastrointestinal Agents

Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)


Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)


API SUPPLIERS

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LGM Pharma

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Vamsi Labs

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HRV Pharma

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Octavius Pharma Pvt. Ltd

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Tagoor Laboratories

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Dipharma

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EU WC

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Vamsi Labs

India
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Cyproheptadine Hydrochloride EP

Date of Issue : 2025-11-12

Valid Till : 2028-07-02

Written Confirmation Number : WC-0155

Address of the Firm : A-14, A-15, A-31, A-32 & A-33, M.I.D.C. Area, Chincholi, Solapur-413 255, Mahara...

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02

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Cyproheptadine Hydrochloride BP/USP/Ph.Eur

Date of Issue : 2022-08-16

Valid Till : 2025-08-13

Written Confirmation Number : WC-0229

Address of the Firm : Survey No. 270, Nawabpet Village, Shivampet Mandai, Medak District, Telangana-50...

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Cyproheptadine Hydrochloride

Date of Issue : 2020-06-18

Valid Till : 2022-08-13

Written Confirmation Number : WC-0229A2

Address of the Firm : Survey No.270, Nawabpet (V), Shivampet (M), Medak District, Telangana State, Ind...

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Cyproheptadine Hydrochloride IP/USP/Ph.Eur/BP

Date of Issue : 2023-04-18

Valid Till : 2026-04-17

Written Confirmation Number : WC-0555

Address of the Firm : Plot No.: 165-182, APIIC Growth Center, Thumakunta, Anantapur-515211, Andhra Pra...

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Cyproheptadine Hydrochloride BP/USP/Ph.Eur.

Date of Issue : 2025-08-01

Valid Till : 2028-07-14

Written Confirmation Number : WC-0183

Address of the Firm : Unit -Il, Plot No.79, Jawaharlal Nehru Pharma City, Thanam (V), Parawada (M), An...

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Cyproheptadine Hydrochloride BP/USP/Ph. Eur

Date of Issue : 2025-05-15

Valid Till : 2028-07-04

Written Confirmation Number : WC-0070

Address of the Firm : Plot No. 37/A, 38, 39A&B, Phase-l, IDA, Jeedimetla, Hyderabad, 500055, Telangana...

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Cyproheptadine Hydrochloride USP/Ph.Eur./BP/IP

Date of Issue : 2024-06-12

Valid Till : 2027-05-12

Written Confirmation Number : WC-0598

Address of the Firm : Unit-V: Plot No. 24, 24A & 24B, APSEZ-DENOTIFIED Area, Rambilli(M), Atchutapuram...

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Cyproheptadine Hydrochloride USP/BP/Ph.Eur

Date of Issue : 2022-06-14

Valid Till : 2025-07-04

Written Confirmation Number : WC-0070nA2

Address of the Firm : 37/A, 38, 39 A&B, PHASE-1, IDA, Jeedimetla, Hyderabad, 500 055, Telangana, India

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Cyproheptadine Hydrochloride USP/BP

Date of Issue : 2021-02-12

Valid Till : 2022-07-04

Written Confirmation Number : WC-0070Amended

Address of the Firm : Unit-1, 37/A, 38, 39 A&B, PHASE-1, IDA, Jeedimetla, Hyderabad, 500 055, Telangan...

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NDC API

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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 66412-0122

Start Marketing Date : 2025-06-12

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

Vamsi Labs

02

VMX
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 46438-0036

Start Marketing Date : 1980-01-07

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 62991-1232

Start Marketing Date : 2011-12-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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Medisca Inc.

U.S.A
VMX
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Medisca Inc.

U.S.A
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 38779-1226

Start Marketing Date : 2014-08-20

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Olon SpA

Italy
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Olon SpA

Italy
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 17337-0508

Start Marketing Date : 2017-04-06

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Olon S.p.A.

Italy
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Olon S.p.A.

Italy
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 17337-0553

Start Marketing Date : 2024-09-23

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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VMX
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 71554-003

Start Marketing Date : 2019-04-25

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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VMX
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 49452-2409

Start Marketing Date : 2000-02-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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VMX
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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 66577-014

Start Marketing Date : 2018-01-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CYPROHEPTADINE HYDROCHLORIDE

NDC Package Code : 66577-040

Start Marketing Date : 2018-01-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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04-Jan-2022
29-Dec-2025
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Drugs in Development

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Details:

KT-110, a new and innovative approach based on dual receptor targeting. Study evaluates the efficacy, safety and tolerance of KT-110, a combination of 2 molecules protected by a compositional patent, on alcohol consumption in patients suffering from severe alcoholism.


Lead Product(s): Cyproheptadine Hydrochloride,Prazosin Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: ECSOR

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 30, 2021

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01

VMX
Not Confirmed
VMX
Not Confirmed

Details : KT-110, a new and innovative approach based on dual receptor targeting. Study evaluates the efficacy, safety and tolerance of KT-110, a combination of 2 molecules protected by a compositional patent, on alcohol consumption in patients suffering from seve...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 30, 2021

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  • Development Update

Details:

Remdesivir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of COVID-19.


Lead Product(s): Remdesivir,Imatinib Mesylate,Dexamethasone,Cenicriviroc,Icatibant Acetate,Apremilast,Dornase Alfa,Celecoxib,

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: University of California, San Francisco | University of Pennsylvania | Gabrail Cancer Center Research | University of Alabama at Birmingham | University of Colorado, Denver | University of Southern California | Yale University | Wake Forest University Hea

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 27, 2020

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02

QuantumLeap Healthcare Collaborative

Country
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VMX
Not Confirmed

QuantumLeap Healthcare Collaborative

Country
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VMX
Not Confirmed

Lead Product(s) : Remdesivir,Imatinib Mesylate,Dexamethasone,Cenicriviroc,Icatibant Acetate,Apremilast,Dornase Alfa,Celecoxib,

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : University of California, San Francisco | University of Pennsylvania | Gabrail Cancer Center Research | University of Alabama at Birmingham | University of Colorado, Denver | University of Southern California | Yale University | Wake Forest University Hea

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Remdesivir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of COVID-19.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 27, 2020

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Details:

Cyproheptadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Alcoholism.


Lead Product(s): Cyproheptadine Hydrochloride,Prazosin Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: ECSOR

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 27, 2019

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03

VMX
Not Confirmed
VMX
Not Confirmed

Details : Cyproheptadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Alcoholism.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 27, 2019

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Details:

Cyproheptadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Cyproheptadine Hydrochloride,Megestrol Acetate

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Severance Hospital

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 18, 2015

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04

LG Life Sciences

South Korea
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VMX
Not Confirmed

LG Life Sciences

South Korea
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VMX
Not Confirmed

Details : Cyproheptadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 18, 2015

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Details:

Cyproheptadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Cyproheptadine Hydrochloride,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Asan Medical Center

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 26, 2011

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05

LG Life Sciences

South Korea
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VMX
Not Confirmed

LG Life Sciences

South Korea
arrow
VMX
Not Confirmed

Details : Cyproheptadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 26, 2011

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Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATE SUPPLIERS

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01

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

CAS Number : 2222-33-5

End Use API : Cyproheptadine Hydrochloride

About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...

Vamsi Labs

02

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

CAS Number : 1210-35-1

End Use API : Cyproheptadine Hydrochloride

About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...

Vamsi Labs

03

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

CAS Number : 3967-32-6

End Use API : Cyproheptadine Hydrochloride

About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...

Vamsi Labs

04

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

CAS Number : 5570-77-4

End Use API : Cyproheptadine Hydrochloride

About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...

Vamsi Labs

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 2222-33-5

End Use API : Cyproheptadine Hydrochloride

About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...

Tagoor Laboratories

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 5570-77-4

End Use API : Cyproheptadine Hydrochloride

About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...

Tagoor Laboratories

07

VMX
Not Confirmed
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VMX
Not Confirmed
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CAS Number : 2222-33-5

End Use API : Cyproheptadine Hydrochloride

About The Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, ant...

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08

VMX
Not Confirmed
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VMX
Not Confirmed
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CAS Number : 2222-33-5

End Use API : Cyproheptadine Hydrochloride

About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...

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CAS Number : 5570-77-4

End Use API : Cyproheptadine Hydrochloride

About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...

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FDA Orange Book

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RLD : No

TE Code :

CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1982-01-01

Application Number : 87129

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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RLD : No

TE Code : AA

CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 2018-04-11

Application Number : 209172

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

03

AM THERAP

U.S.A
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AM THERAP

U.S.A
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1985-02-15

Application Number : 88798

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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WATSON LABS

Ireland
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WATSON LABS

Ireland
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1982-01-01

Application Number : 85245

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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WATSON LABS

Ireland
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WATSON LABS

Ireland
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1982-01-01

Application Number : 86165

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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APPCO

U.S.A
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APPCO

U.S.A
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 2016-11-29

Application Number : 206553

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1982-01-01

Application Number : 87056

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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QUAGEN

U.S.A
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QUAGEN

U.S.A
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 2021-02-24

Application Number : 212491

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : SYRUP;ORAL

Dosage Strength : 2MG/5ML

Approval Date : 2021-12-21

Application Number : 205431

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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VITARINE

Country
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VITARINE

Country
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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : CYPROHEPTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1982-01-01

Application Number : 87284

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Europe

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Cyproheptadine Hydrochloride

Brand Name : Periactin

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date : 1961-02-01

Application Number : 35622

Regulatory Info : Authorized

Registration Country : Spain

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Carnitine Hydrochloride; Arginine Aspartate; Cyproheptadine Hydrochloride

Brand Name : Desarrol

Dosage Form : Solution

Dosage Strength : 50MG; 25MG; 0.2 MG

Packaging :

Approval Date : 1972-06-01

Application Number : 50242

Regulatory Info : Authorized

Registration Country : Spain

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Arginine Aspartate; Cyproheptadine Ketoglutarate

Brand Name : Dynamogen

Dosage Form : Oral Solution

Dosage Strength : 3MG; 1G

Packaging :

Approval Date : 1977-05-01

Application Number : 53715

Regulatory Info : Authorized

Registration Country : Spain

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Arginine aspartase; Cyproheptadine alfa-ketoglutarate

Brand Name : Dynamogen®

Dosage Form : Oral Solution

Dosage Strength :

Packaging :

Approval Date : 19-07-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Cobamamide; Cyproheptadine Hydrochloride

Brand Name : Tonico Juventus

Dosage Form : Extemporanean Suspension

Dosage Strength : 1MG; 250MCG

Packaging :

Approval Date : 1970-11-01

Application Number : 49107

Regulatory Info : Suspensed

Registration Country : Spain

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Seid Sa

Spain
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Seid Sa

Spain
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Cobamamide; Cyproheptadine Hydrochloride

Brand Name : Covitasa Capsules

Dosage Form : Capsule

Dosage Strength :

Packaging :

Approval Date : 1969-11-01

Application Number : 48622

Regulatory Info : Cancelled

Registration Country : Spain

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Carnitine Hydrochloride; Lysine Hydrochloride; Cyproheptadine Hydrochloride

Brand Name : Pranzo

Dosage Form : Oral Solution

Dosage Strength : 62.5MG; 1.25MG; 0.5MG

Packaging :

Approval Date : 1969-05-01

Application Number : 47944

Regulatory Info : Authorized

Registration Country : Spain

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AVANTGARDE (Gruppo SIGMA-TAU)

Country
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AVANTGARDE (Gruppo SIGMA-TAU)

Country
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Cyproheptadine

Brand Name : Periactin

Dosage Form :

Dosage Strength : 30 Cpr 4 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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AVANTGARDE (Gruppo SIGMA-TAU)

Country
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AVANTGARDE (Gruppo SIGMA-TAU)

Country
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Cyproheptadine

Brand Name : Periactin

Dosage Form :

Dosage Strength : The Scir 150 Ml 0.04%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Canada

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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : EURO-CYPROHEPTADINE 2MG/5ML

Dosage Form : SYRUP

Dosage Strength : 2MG/5ML

Packaging : 250ML

Approval Date :

Application Number : 2466732

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : JAMP-CYPROHEPTADINE

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number : 2332248

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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CYPROHEPTADINE HYDROCHLORIDE

Brand Name : MAR-CYPROHEPTADINE

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number : 2533065

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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Cyproheptadine Hydrochloride

Brand Name : PMS-CYPROHEPTADINE HCL TAB 4MG

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging : 100/500

Approval Date :

Application Number :

Regulatory Info : OTC

Registration Country : Canada

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South Africa

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Cipla Medpro (Pty) Ltd

South Africa
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Cipla Medpro (Pty) Ltd

South Africa
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Cyproheptadine

Brand Name : Cipla-Actin

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Cyproheptadine

Brand Name : Periactin

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Cyproheptadine

Brand Name : Zyactin

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Regulatory Info :

Registration Country : India

Cyproheptadine Hydrochloride

Brand Name : Cyproheptadine Hydroch...

Dosage Form : DC Granules

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

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Packaging :

Regulatory Info :

Cyproheptadine Hydrochloride

Dosage : DC Granules

Dosage Strength : 4MG

Brand Name : Cyproheptadine Hydroch...

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

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Regulatory Info :

Registration Country : India

Cyproheptadine Hydrochloride

Brand Name : Cyproheptadine Hydroch...

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

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Packaging :

Regulatory Info :

Cyproheptadine Hydrochloride

Dosage : Tablet

Dosage Strength : 4MG

Brand Name : Cyproheptadine Hydroch...

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

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Cyproheptadine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

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Cyproheptadine

Dosage : Tablet

Dosage Strength : 4MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

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Cyproheptadine Hydrochloride

Brand Name : Goodvita

Dosage Form : Capsule

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Cyproheptadine Hydrochloride

Dosage : Capsule

Dosage Strength : 4MG

Brand Name : Goodvita

Approval Date :

Application Number :

Registration Country : India

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Cyproheptadine Hydrochloride

Brand Name : Hungry Up

Dosage Form : Syrup

Dosage Strength : 2MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Cyproheptadine Hydrochloride

Dosage : Syrup

Dosage Strength : 2MG/5ML

Brand Name : Hungry Up

Approval Date :

Application Number :

Registration Country : India

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Cyproheptadine Hydrochloride

Brand Name : Siiper Pepti

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Cyproheptadine Hydrochloride

Dosage : Tablet

Dosage Strength : 4MG

Brand Name : Siiper Pepti

Approval Date :

Application Number :

Registration Country : India

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Cyproheptadine Hydrochloride

Brand Name :

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number : 40644

Regulatory Info : Generic

Registration Country : India

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Cyproheptadine Hydrochloride

Dosage : TABLET

Dosage Strength : 4MG

Brand Name :

Approval Date :

Application Number : 40644

Registration Country : India

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Cyproheptadine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Cyproheptadine

Dosage : Tablet

Dosage Strength : 4MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Pluviaendo

Turkey
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Pluviaendo

Turkey
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Cyproheptadine Hydrochloride

Brand Name :

Dosage Form : Oral Solution

Dosage Strength : 2MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Pluviaendo

Turkey
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Pluviaendo

Turkey
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Cyproheptadine Hydrochloride

Dosage : Oral Solution

Dosage Strength : 2MG/5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Turkey

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Cyproheptadine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Cyproheptadine Hydrochloride

Dosage : Tablet

Dosage Strength : 2MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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DATA COMPILATION #PharmaFlow

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

Impressions: 9478

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205431

FDA
21 Dec 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212423

FDA
24 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206676

FDA
16 Apr 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209108

FDA
20 Oct 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209172

FDA
13 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203191

FDA
17 Jul 2017

Global Sales Information

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US Medicaid Prescriptions

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Company : Amneal Pharmace

CyproHEPtadine HCl

Drug Cost (USD) : 899,483

Year : 2023

Prescribers : 14642

Prescriptions : 34496

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02

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Company : Apnar Pharma, L

CyproHEPtadine HCl

Drug Cost (USD) : 2,141

Year : 2023

Prescribers : 66

Prescriptions : 90

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03

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Company : Bayshore Pharma

CyproHEPtadine HCl

Drug Cost (USD) : 519,141

Year : 2023

Prescribers : 5838

Prescriptions : 13532

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04

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Company : Breckenridge

CyproHEPtadine HCl

Drug Cost (USD) : 101,553

Year : 2023

Prescribers : 1472

Prescriptions : 3350

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05

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Company : Chartwell Rx Ll

CyproHEPtadine HCl

Drug Cost (USD) : 1,024

Year : 2023

Prescribers : 11

Prescriptions : 15

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06

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Company : Ingenus Pharmac

CyproHEPtadine HCl

Drug Cost (USD) : 318,884

Year : 2023

Prescribers : 4041

Prescriptions : 10016

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07

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Company : Lannett Co. Inc

CyproHEPtadine HCl

Drug Cost (USD) : 9,127

Year : 2023

Prescribers : 160

Prescriptions : 284

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08

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Company : Marlex Pharm.

CyproHEPtadine HCl

Drug Cost (USD) : 2,194

Year : 2023

Prescribers : 155

Prescriptions : 281

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09

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Company : Quagen Pharmace

CyproHEPtadine HCl

Drug Cost (USD) : 483,853

Year : 2023

Prescribers : 6751

Prescriptions : 16046

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Company : Rising Pharm

CyproHEPtadine HCl

Drug Cost (USD) : 148,030

Year : 2023

Prescribers : 1870

Prescriptions : 4301

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Regulatory FDF Prices

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Brand Name : CYPROHEPTADINE HYDROCHLORIDE

U.S.A
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Brand Name : CYPROHEPTADINE HYDROCHLORIDE

U.S.A
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Cyproheptadine Hydrochloride

Dosage Form : SYRUP;ORAL

Dosage Strength : 2MG/5ML

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : RX

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Brand Name : Periactin

Country
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Brand Name : Periactin

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Cyproheptadine Hydrochloride

Dosage Form :

Dosage Strength : 30 Cpr 4 Mg  

Price Per Pack (Euro) : 5

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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03

Brand Name : Periactin

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Brand Name : Periactin

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Cyproheptadine Hydrochloride

Dosage Form :

Dosage Strength : The Scir 150 Ml 0.04%  

Price Per Pack (Euro) : 5

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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Market Place

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APIs

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REF. STANDARDS & IMPURITIES

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Others

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  • WHO-GMP

Virtual BoothSigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.

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Cyproheptadine Related Compound A

CAS Number :

Quantity Per Vial :

Sale Unit :

Price : $707.00

Details :

Monograph : PHR2685-50MG

Storage : +2°C to +8°C

Code/Batch No :

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  • WHO-GMP

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Cyproheptadine Hydrochloride

CAS Number :

Quantity Per Vial :

Sale Unit :

Price : $211.00

Details :

Monograph : PHR2684-500MG

Storage : +2°C to +30°C

Code/Batch No :

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03

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CAS Number :

Quantity Per Vial :

Sale Unit :

Price : $707.00

Details :

Monograph : PHR2685-50MG

Storage : +2?C to +8?C

Code/Batch No :

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CAS Number :

Quantity Per Vial :

Sale Unit :

Price : $211.00

Details :

Monograph : PHR2684-500MG

Storage : +2?C to +30?C

Code/Batch No :

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XYZ Pharma

Gabon
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XYZ Pharma

Gabon
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Cyproheptadine Related Compound A (40 mg) (5H...

CAS Number : 256-81-5

Quantity Per Vial : 40

Sale Unit : mg

Price : $835.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1161010 / R128R0

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XYZ Pharma

Gabon
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XYZ Pharma

Gabon
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Cyproheptadine Related Compound C (25 mg) (5-...

CAS Number : 3967-32-6

Quantity Per Vial : 25

Sale Unit : mg

Price : $877.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1161032 / R078J0

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XYZ Pharma

Gabon
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XYZ Pharma

Gabon
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Cyproheptadine Hydrochloride (500 mg)

CAS Number : 41354-29-4

Quantity Per Vial : 500

Sale Unit : mg

Price : $245.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1161000 / R072P0

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ABOUT THIS PAGE

Looking for 969-33-5 / Cyproheptadine Hydrochloride API manufacturers, exporters & distributors?

Cyproheptadine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cyproheptadine Hydrochloride 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 Cyproheptadine Hydrochloride manufacturer or Cyproheptadine Hydrochloride supplier for your needs.

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

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

API | Excipient name

Cyproheptadine Hydrochloride

Synonyms

969-33-5, Cyproheptadine hcl, Periactin hydrochloride, Anarexol, Cipractin, Nuran

Cas Number

969-33-5

Unique Ingredient Identifier (UNII)

0S9323MCT0

About Cyproheptadine Hydrochloride

A serotonin antagonist and a histamine H1 blocker used as antipruritic, appetite stimulant, antiallergic, and for the post-gastrectomy dumping syndrome, etc.

Cyproheptadine Manufacturers

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

Cyproheptadine Suppliers

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

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

Cyproheptadine USDMF

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

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

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

Cyproheptadine 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 Cyproheptadine Drug Master File in Japan (Cyproheptadine JDMF) empowers Cyproheptadine 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 Cyproheptadine JDMF during the approval evaluation for pharmaceutical products. At the time of Cyproheptadine 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 Cyproheptadine suppliers with JDMF on PharmaCompass.

Cyproheptadine CEP

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

A Cyproheptadine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cyproheptadine 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 Cyproheptadine suppliers with CEP (COS) on PharmaCompass.

Cyproheptadine WC

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

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

Cyproheptadine 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 Cyproheptadine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cyproheptadine GMP

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

Cyproheptadine CoA

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

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

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