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Chemistry

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Also known as: 139264-17-8, Zomig, Zomigoro, 311c90, Zomigon, Flezol

Molecular Formula

C₁₆H₂₁N₃O₂

Molecular Weight

287.36 g/mol

InChI Key

ULSDMUVEXKOYBU-ZDUSSCGKSA-N

FDA UNII

2FS66TH3YW

Zolmitriptan is a member of the triptan class of agents with anti-migraine properties. Zolmitriptan selectively binds to and activates serotonin (5-HT) 1B receptors expressed in intracranial arteries and 5-HT 1D receptors located on peripheral trigeminal sensory nerve terminals in the meninges and central terminals in brainstem sensory nuclei. Receptor binding results in constriction of cranial vessels, reduction of vessel pulsation and inhibition of nociceptive transmission, thereby providing relief of migraine headaches. Zolmitriptan may also relieve migraine headaches by inhibition of pro-inflammatory neuropeptide release.

Zolmitriptan is a Serotonin-1b and Serotonin-1d Receptor Agonist. The mechanism of action of zolmitriptan is as a Serotonin 1b Receptor Agonist, and Serotonin 1d Receptor Agonist.

1 2D Structure

Zolmitriptan

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1,3-oxazolidin-2-one

2.1.2 InChI

InChI=1S/C16H21N3O2/c1-19(2)6-5-12-9-17-15-4-3-11(8-14(12)15)7-13-10-21-16(20)18-13/h3-4,8-9,13,17H,5-7,10H2,1-2H3,(H,18,20)/t13-/m0/s1

2.1.3 InChI Key

ULSDMUVEXKOYBU-ZDUSSCGKSA-N

2.1.4 Canonical SMILES

CN(C)CCC1=CNC2=C1C=C(C=C2)CC3COC(=O)N3

2.1.5 Isomeric SMILES

CN(C)CCC1=CNC2=C1C=C(C=C2)C[C@H]3COC(=O)N3

2.2 Other Identifiers

2.2.1 UNII

2FS66TH3YW

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 311c90

2. 4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-2-oxazolidinone

3. Ascotop

4. Flezol

5. Zomig

6. Zomigoro

2.3.2 Depositor-Supplied Synonyms

1. 139264-17-8

2. Zomig

3. Zomigoro

4. 311c90

5. Zomigon

6. Flezol

7. Zomig-zmt

8. C16h21n3o2

9. Bw-311c90

10. (s)-4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)oxazolidin-2-one

11. Zolmitriptan (zomig)

12. (s)-4-[3-(2-dimethylamino-ethyl)-1h-indol-5-ylmethyl]-oxazolidin-2-one

13. Nsc-760383

14. Cvt-427

15. 2fs66th3yw

16. Chembl1185

17. (s)-4-((3-(2-(dimethylamino)ethyl)indol-5-yl)methyl)-2-oxazolidinone

18. Chebi:10124

19. (s)-4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-2-oxazolidinone

20. (4s)-4-[[3-[2-(dimethylamino)ethyl]-1h-indol-5-yl]methyl]-1,3-oxazolidin-2-one

21. Zomig Nasal Spray

22. Zomig Zmt

23. Ascotopand

24. Ascotop

25. Zolmitriptan [usan]

26. 4-[[3-(2-dimethylaminoethyl)-1h-indol-5-yl]methyl]oxazolidin-2-one

27. (4s)-4-[[3-[2-(dimethylamino)ethyl]-1h-indol-5-yl]methyl]-2-oxazolidinone

28. (s)-4-[[3-[2-(dimethylamino)ethyl]-1h-indol-5-yl]methyl]-2-oxazolidinone

29. (4s)-4-({3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}methyl)-1,3-oxazolidin-2-one

30. 2-oxazolidinone, 4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-, (s)-

31. Dsstox_cid_25933

32. Dsstox_rid_81232

33. Dsstox_gsid_45933

34. 311-c-90

35. Zipton

36. Zolmitriptane

37. Zolmitriptanum

38. Zominat

39. Rapimelt

40. (4s)-4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-2-oxazolidinone

41. Smr000449310

42. Cas-139264-17-8

43. Zomig (tn)

44. Zolmitriptan Rapidfilm

45. Unii-2fs66th3yw

46. 4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-2-oxazolidinone

47. Zolmitriptan [usan:inn:ban]

48. Ncgc00095155-01

49. Mfcd00871503

50. Ks-5072

51. Spectrum2_000728

52. Zolmitriptan [mi]

53. Zolmitriptan [inn]

54. Zolmitriptan [jan]

55. Gtpl60

56. (4s)-4-[[3-(2-dimethylaminoethyl)-1h-indol-5-yl]methyl]-1,3-oxazolidin-2-one

57. Zolmitriptan [vandf]

58. Schembl33336

59. Zolmitriptan [mart.]

60. Mls000758208

61. Mls001424172

62. Bidd:gt0040

63. Spectrum1505281

64. Zolmitriptan [usp-rs]

65. Zolmitriptan [who-dd]

66. Spbio_000656

67. Zolmitriptan (jan/usp/inn)

68. Dtxsid8045933

69. Zinc15515

70. Zolmitriptan, >=98% (hplc)

71. Hms1922b04

72. Hms2052k17

73. Hms2093o14

74. Hms2235i22

75. Hms3714h11

76. Hms3884a06

77. Pharmakon1600-01505281

78. Zolmitriptan [orange Book]

79. Zolmitriptan [ep Monograph]

80. Act04392

81. Bcp10513

82. Hy-b0229

83. Tox21_111455

84. Zolmitriptan [usp Monograph]

85. Bdbm50033383

86. Ccg-38993

87. Nsc760383

88. S1649

89. Akos015850706

90. Tox21_111455_1

91. Db00315

92. Nc00382

93. Nsc 760383

94. (s)-n,n-dimethyl-2-[5-(2-oxo-1,3-oxazolidin-4-ylmethyl)-1h-indol-3-yl]ethylamine

95. Ncgc00263884-02

96. Ncgc00263884-03

97. Ncgc00263884-08

98. Bz164590

99. Bw-311c90;311c90

100. Sbi-0206762.p001

101. B2261

102. Sw197762-2

103. Z0024

104. 64z178

105. C07218

106. D00415

107. Ab00698244-05

108. Ab00698244_06

109. Q218820

110. Sr-05000001693

111. J-007257

112. Sr-05000001693-1

113. Zolmitriptan, United States Pharmacopeia (usp) Reference Standard

114. (4s)-4-[[3-[2-(dimethylamino)ethyl]-1h-indol-5-yl]methyl-2-oxazolidinone

115. (s)-4-{3-[2-(dimethylamino)ethyl]-1h-indol-5-ylmethyl}oxazolidin-2-one

116. (4s)-4-((3-(2-(dimethylamino)ethyl) -1h-indol-5-yl)methyl)-2-oxazolidinone

117. (s) -n,n-dimethyl-2- [5- (2-oxo-1,3-oxazolidin-4-ylmethyl) -1h -indol-3-yl]ethylamine

118. (s)-4-({3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}methyl)-1,3-oxazolidin-2-one

119. (s)-n,n-dimethyl-2-[5-(2-oxo-1,3-oxazolidin-4-ylmethyl)-1h -indol-3-yl]ethylamine

120. 2-oxazolidinone, 4-[[3-[2-(dimethylamino)ethyl]-1h-indol-5-yl]methyl]-, (4s)-

121. 139264-25-8

122. Zmt

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₁N₃O₂
Molecular Weight	287.36 g/mol
XLogP3	2.2
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	5
Exact Mass	287.16337692 g/mol
Monoisotopic Mass	287.16337692 g/mol
Topological Polar Surface Area	57.4 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	375
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Zolmitriptan
PubMed Health	Zolmitriptan
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet; Tablet, orally disintegrating
Route	Oral
Strength	2.5mg; 5mg
Market Status	Prescription
Company	Mylan Pharms; Apotex; Teva Pharms Usa; Invagen Pharms; Sun Pharma Global; Glenmark Generics; Zydus Pharms Usa

2 of 6
Drug Name	Zomig
PubMed Health	Zolmitriptan (Into the nose)
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet; Spray
Route	Oral; Nasal
Strength	2.5mg; 2.5mg/spray; 5mg; 5mg/spray
Market Status	Prescription
Company	Ipr; Astrazeneca

3 of 6
Drug Name	Zomig-zmt
PubMed Health	Zolmitriptan (By mouth)
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet, orally disintegrating
Route	Oral
Strength	2.5mg; 5mg
Market Status	Prescription
Company	Astrazeneca

4 of 6
Drug Name	Zolmitriptan
PubMed Health	Zolmitriptan
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet; Tablet, orally disintegrating
Route	Oral
Strength	2.5mg; 5mg
Market Status	Prescription
Company	Mylan Pharms; Apotex; Teva Pharms Usa; Invagen Pharms; Sun Pharma Global; Glenmark Generics; Zydus Pharms Usa

5 of 6
Drug Name	Zomig
PubMed Health	Zolmitriptan (Into the nose)
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet; Spray
Route	Oral; Nasal
Strength	2.5mg; 2.5mg/spray; 5mg; 5mg/spray
Market Status	Prescription
Company	Ipr; Astrazeneca

6 of 6
Drug Name	Zomig-zmt
PubMed Health	Zolmitriptan (By mouth)
Drug Classes	Antimigraine
Drug Label	ZOMIG (zolmitriptan) Tablets and ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dime...
Active Ingredient	Zolmitriptan
Dosage Form	Tablet, orally disintegrating
Route	Oral
Strength	2.5mg; 5mg
Market Status	Prescription
Company	Astrazeneca

4.2 Drug Indication

Zolmitriptan is indicated for the acute treatment of migraine with or without auras in patients aged 18 and over.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Zolmitriptan, like other triptans, is a serotonin (5-hydroxytryptamine; 5-HT) receptor agonist, with enhanced specificity for the 5-HT_1B and 5-HT_1D receptor subtypes. It is through the downstream effects of 5-HT_1B/1D activation that triptans are proposed to provide acute relief of migraines. Zolmitriptan is also a vasoconstrictor, leading to possible adverse cardiovascular effects such as myocardial ischemia/infarction, arrhythmias, cerebral and subarachnoid hemorrhage, stroke, gastrointestinal ischemia, and peripheral vasospastic reactions. In addition, chest/throat/neck/jaw pain, tightness, and/or pressure has been reported, along with the possibility of medication overuse headaches and serotonin syndrome. Patients with phenylketonuria should be advised that ZOMIG-ZMT contains phenylalanine.

5.2 MeSH Pharmacological Classification

Serotonin 5-HT1 Receptor Agonists

Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT1 RECEPTORS. Included under this heading are agonists for one or more of the specific 5-HT1 receptor subtypes. (See all compounds classified as Serotonin 5-HT1 Receptor Agonists.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

ZOLMITRIPTAN

5.3.2 FDA UNII

2FS66TH3YW

5.3.3 Pharmacological Classes

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

5.4 ATC Code

N02CC03

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

N - Nervous system

N02 - Analgesics

N02C - Antimigraine preparations

N02CC - Selective serotonin (5ht1) agonists

N02CC03 - Zolmitriptan

5.5 Absorption, Distribution and Excretion

Absorption

Zolmitriptan tablets have a mean absolute oral bioavailability of approximately 40%, with food having no effect on the rate or extent of absorption. The dosing kinetics are linear over a range of 2.5 to 50 mg with 75% of the eventual C_max being attained within 1 hour of dosing. The median T_max for the tablet form is 1.5 hours, while for the orally disintegrating tablet form, it is 3 hours. The AUC across studies was in the range of 84.4-173.8 ng/mL*h while the C_max was between 16 and 25.2 ng/mL. Zolmitriptan administered as a nasal spray is detected in the plasma within 2-5 minutes, compared to 10-15 minutes for the tablet form; the faster kinetics likely reflect fast absorption across the nasal mucosa. The bioavailability compared to the tablet is 102%, and plasma zolmitriptan concentration is maintained for 4-6 hours after intranasal delivery. The active N-desmethyl metabolite of zolmitriptan has a mean plasma concentration that is roughly two-thirds of zolmitriptan, regardless of dosage route or concentration.

Route of Elimination

Zolmitriptan is primarily excreted in urine (approximately 65%) and feces (approximately 30%). Within urine, the most common form is the indole acetic acid metabolite (31%), followed by the N-oxide (7%), and N-desmethyl (4%) metabolites; the majority of zolmitriptan recovered in feces remains unchanged.

Volume of Distribution

Zolmitriptan has a volume of distribution between 7 and 8.4 L/kg.

Clearance

Zolmitriptan has a clearance of 31.5 mL/min/kg for oral tablets and 25.9 mL/min/kg for nasal administration; one-sixth of the clearance is renal.

5.6 Metabolism/Metabolites

Zolmitriptan is metabolized in the liver, and studies using cytochrome P450 inhibitors like [cimetidine] suggest that it is likely metabolized by CYP1A2, as well as by monoamine oxidase (MAO). Zolmitriptan metabolism results in three major metabolites: an active N-desmethyl metabolite (183C91) as well as inactive N-oxide (1652W92) and indole acetic acid (2161W92) metabolites.

Zolmitriptan has known human metabolites that include N-Desmethylzolmitriptan and Zolmitriptan N-oxide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

Zolmitriptan has a mean elimination half-life of approximately three hours, while its active N-desmethyl metabolite has a slightly longer (approximately 3.5 hours) half-life.

5.8 Mechanism of Action

Migraines are complex physiological events characterized by unilateral throbbing headaches combined with photophobia and other aversions to sensory input. Migraine attacks are generally divided into phases: the premonitory phase, which typically involves irritability, fatigue, yawning, and stiff neck; the headache phase, which lasts for between four and 72 hours; and the postdrome phase, which lasts for up to a day following resolution of pain and whose symptoms are similar to those of the premonitory phase. In addition, neurological deficits, collectively termed migraine aura, may precede the headache phase. The underlying pathophysiology of migraines is a matter of active research but involves both neurological and vascular components. The head pain associated with migraine is thought to be a consequence of activation of the nociceptive nerves comprising the trigeminocervical complex (TCC). Terminals of nociceptive nerves that innervate the dura matter release vasoactive peptides, such as calcitonin gene-related peptide (CGRP), resulting in cranial vasodilation. Finally, when present, migraine aura appears to correlate with a transient wave(s) of cortical depolarization, termed cortical spreading depression (CSD). Triptans, including zolmitriptan, are proposed to act in three ways. The main mechanism is through modulation of nociceptive nerve signalling in the central nervous system through 5-HT_1B/1D receptors throughout the TCC and associated areas of the brain. In addition, triptans can enhance vasoconstriction, both through direct 5-HT_1B-mediated dilation of cranial blood vessels, as well as through 5-HT_1D-mediated suppression of CGRP release. Although triptans are classically described solely in terms of their effects on 5-HT_1B/1D receptors, they also act as 5-HT_1F agonists as well. This 5-HT subtype is also found throughout the TCC, but is not present appreciably in cerebral vasculature; the significance of triptan-mediated 5-HT_1F activation is currently not well described. Additionally, CSD that initiates in the ipsilateral parietal region may exert its effects in a manner that relies on 5-HT_1B/1D receptor activation, suggesting that triptans may have some effect on CSD-mediated symptoms.

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USDMF

01

Inke Sa

Spain

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Digital Content

ZOLMITRIPTAN

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-06

Pay. Date : 2019-02-28

DMF Number : 24649

Submission : 2011-02-14

Status : Active

Type : II

02

Teva Pharmaceutical Industries Ltd

Israel

Isranalytica

Attending

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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ZOLMITRIPTAN

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-13

DMF Number : 22205

Submission : 2008-11-10

Status : Active

Type : II

Product Web Link

03

Apotex Pharmachem India Pvt Ltd

Canada

BIO Partnering at JPM

Not Confirmed

04

Glenmark Life Sciences Ltd

India

BIO Partnering at JPM

Not Confirmed

Not Confirmed

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CEP/COS

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JDMF

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EU WC

01

Alembic Pharmaceuticals Limited

India

BIO Partnering at JPM

Not Confirmed

02

Apotex Pharmachem

BIO Partnering at JPM

Not Confirmed

06

Jubilant Pharmova

India

BIO Partnering at JPM

Not Confirmed

07

Natco Pharma

India

BIO Partnering at JPM

Not Confirmed

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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AP","supplier":"AZAKEM LABS PRIVATE ","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"HABIB METROPOLITAN BANK ","customerCountry":"PAKISTAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"11.5","totalValueFC":"1051.6","currency":"USD","unitRateINR":883.6613000000001,"date":"04-Oct-2024","totalValueINR":"88366.13","totalValueInUsd":"1051.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4556811","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.146A, PHASE-II,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS API (PHARMACEUTICALS RAW MATERIAL FOR PHARMAINDUSTRIES) PRODUCT- ZOLMITRIPTAN","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"TO THE ORDER OF","customerCountry":"CHINA","quantity":"6.90","actualQuantity":"6.9","unit":"KGS","unitRateFc":"7500","totalValueFC":"51134.2","currency":"USD","unitRateINR":622700.6333333333,"date":"25-Oct-2024","totalValueINR":"4296634.37","totalValueInUsd":"51134.2","indian_port":"Ahmedabad Air","hs_no":"29334900","bill_no":"5109965","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32518002870 DT. 22.10.2024 ZOLMITRIPTAN","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER","customerCountry":"EGYPT","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"8330","totalValueFC":"2402.1","currency":"USD","unitRateINR":672810.66666666674,"date":"28-Oct-2024","totalValueINR":"201843.2","totalValueInUsd":"2402.1","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"5202778","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"ZOLMITRIPTAN","address":"Plot no 564-A-22, Road No 92 ,? Jubilee Hills, Film Nagar, Shaikpet, ,? Hyderabad , ?HYDERABAD ,? TELANGANA,? 500096","city":"N\/A","supplier":"TIANISH LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"SQUARE PHARMACEUTICALS","customerCountry":"BANGLADESH","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"8500","totalValueFC":"42009.1","currency":"USD","unitRateINR":709013.80000000005,"date":"26-Nov-2024","totalValueINR":"3545069","totalValueInUsd":"42009.1","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"5931595","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Plot no 564-A-22, Road No 92 ,? Jubilee Hills, Film Nagar, Shaikpet, ,? Hyderabad , ?HYDERABAD ,? TELANGANA,? 500096, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"ZOLMITRIPTAN MFG DATE:APR-2024,RETEST DATE:MAR-2027 BATCH NO:BZLJ240402","address":"PLOT NO.1-A SEC-16A","city":"NOIDA (U.P) INDIA","supplier":"JUBILANT PHARMOVA","supplierCountry":"INDIA","foreign_port":"TOKYO","customer":"TO THE ORDER OF\\'","customerCountry":"JAPAN","quantity":"10.02","actualQuantity":"10.02","unit":"KGS","unitRateFc":"26600","totalValueFC":"263802.1","currency":"USD","unitRateINR":2221734.9461077848,"date":"29-Nov-2024","totalValueINR":"22261784.16","totalValueInUsd":"263802.1","indian_port":"Bangalore Air","hs_no":"29211190","bill_no":"6025150","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT NO.1-A SEC-16A, NOIDA (U.P) INDIA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643049000,"product":"RE-IMPORT ZOLMITRIPTAN (SB NO: 3415280 DT. 27.07.2021)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"ACTAVIS INC","supplierCountry":"INDIA","foreign_port":"#N\/A","customer":"VIATRIS","customerCountry":"INDIA","quantity":"0.88","actualQuantity":"0.884","unit":"KGS","unitRateFc":"12700","totalValueFC":"15717.2","currency":"EUR","unitRateINR":"1324465.5","date":"25-Jan-2022","totalValueINR":"1170827.54","totalValueInUsd":"15717.2","indian_port":"MADRAS AIR","hs_no":"29331999","bill_no":"7231164","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681237800,"product":"ZOLMITRIPTAN (QTY:1 X 200 MG, VALUE:USD 265)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1325000","totalValueFC":"290.7","currency":"USD","unitRateINR":"119131850","date":"12-Apr-2023","totalValueINR":"23826.37","totalValueInUsd":"290.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5476780","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691692200,"product":"RE-IMPORT ZOLMITRIPTAN SB NO:6463359 DT:27.12.2022,6463027DT:27.12.2022","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD","supplier":"ACTAVIS INC","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"21.13","actualQuantity":"21.13","unit":"KGS","unitRateFc":"12700","totalValueFC":"302351.1","currency":"EUR","unitRateINR":"1173459.1","date":"11-Aug-2023","totalValueINR":"25045647.09","totalValueInUsd":"302351.1","indian_port":"CHENNAI AIR","hs_no":"29331999","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"}]

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 - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 20768

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 20768

DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 21231

DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

USFDA APPLICATION NUMBER - 21231

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ABOUT THIS PAGE

Zolmitriptan Manufacturers

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

Zolmitriptan Suppliers

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

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

Zolmitriptan USDMF

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

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

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

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

Zolmitriptan KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Zolmitriptan Drug Master File in Korea (Zolmitriptan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zolmitriptan. The MFDS reviews the Zolmitriptan KDMF as part of the drug registration process and uses the information provided in the Zolmitriptan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Zolmitriptan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Zolmitriptan API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Zolmitriptan suppliers with KDMF on PharmaCompass.

Zolmitriptan CEP

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

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

Zolmitriptan WC

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

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

Zolmitriptan 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 Zolmitriptan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Zolmitriptan GMP

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

Zolmitriptan CoA

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

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

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

35 API Suppliers

18 USDMF

3 CEP/COS

5 JDMF

15 EU WC

2 KDMF

12 NDC API

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FINISHED DOSAGE FORMULATIONS

247 FDF Dossiers

52 FDA Orange Book

155 Europe

19 Canada

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15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 2.5MG

TABLET;ORAL - 5MG

TABLET, ORALLY DISINTEGRATING;ORAL - 2.5MG

TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

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14 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

19 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material