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Also known as: 68291-97-4, Zonegran, 1,2-benzisoxazole-3-methanesulfonamide, 1,2-benzoxazol-3-ylmethanesulfonamide, Exceglan, Excegram
Molecular Formula
C8H8N2O3S
Molecular Weight
212.23  g/mol
InChI Key
UBQNRHZMVUUOMG-UHFFFAOYSA-N
FDA UNII
459384H98V

Zonisamide
A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.
Zonisamide is an Anti-epileptic Agent. The mechanism of action of zonisamide is as a Carbonic Anhydrase Inhibitor, and P-Glycoprotein Inhibitor. The physiologic effect of zonisamide is by means of Decreased Central Nervous System Disorganized Electrical Activity.
1 2D Structure

Zonisamide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1,2-benzoxazol-3-ylmethanesulfonamide
2.1.2 InChI
InChI=1S/C8H8N2O3S/c9-14(11,12)5-7-6-3-1-2-4-8(6)13-10-7/h1-4H,5H2,(H2,9,11,12)
2.1.3 InChI Key
UBQNRHZMVUUOMG-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C2C(=C1)C(=NO2)CS(=O)(=O)N
2.2 Other Identifiers
2.2.1 UNII
459384H98V
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3 Sulfamoylmethyl 1,2 Benzisoxazole

2. 3-sulfamoylmethyl-1,2-benzisoxazole

3. Ad 810

4. Ad-810

5. Ad810

6. Ci 912

7. Ci-912

8. Ci912

9. Zonegran

10. Zonisamide Monosodium

2.3.2 Depositor-Supplied Synonyms

1. 68291-97-4

2. Zonegran

3. 1,2-benzisoxazole-3-methanesulfonamide

4. 1,2-benzoxazol-3-ylmethanesulfonamide

5. Exceglan

6. Excegram

7. Excegran

8. Zonisamidum [latin]

9. Zonisamida [spanish]

10. Ad-810

11. Zonisamida

12. Zonisamidum

13. Ci-912

14. 3-(sulfamoylmethyl)-1,2-benzisoxazole

15. Benzo[d]isoxazol-3-ylmethanesulfonamide

16. Ad 810

17. Ci 912

18. Pd 110843

19. Pd-110843

20. 1-(1,2-benzoxazol-3-yl)methanesulfonamide

21. Spr_2

22. Benzo[d]isoxazol-3-yl-methanesulfonamide

23. 1-(1,2-benzisoxazol-3-yl)methanesulfonamide

24. Ncgc00159319-02

25. Ncgc00159319-04

26. 459384h98v

27. Dsstox_cid_26023

28. Dsstox_rid_81296

29. Dsstox_gsid_46023

30. Tremode

31. Trerief

32. Excegran (tn)

33. Smr000596519

34. Zonisamide (zns)

35. Cas-68291-97-4

36. Hsdb 7293

37. Sr-01000837537

38. Brn 1077076

39. Zonisamide, Zns

40. Ad-810n

41. Zonisamide, 1

42. Unii-459384h98v

43. Zonisamide Solution

44. Mfcd00865316

45. Zonisamide [usan:usp:inn:ban:jan]

46. Zonisamide [mi]

47. Zonisamide [inn]

48. Zonisamide [jan]

49. Zonisamide [hsdb]

50. Zonisamide [usan]

51. Zonisamide [vandf]

52. E-2090

53. Zonisamide [mart.]

54. Zonisamide [usp-rs]

55. Zonisamide [who-dd]

56. Bidd:pxr0183

57. Schembl35458

58. Mls001195632

59. Mls001306491

60. Bidd:gt0708

61. Zonisamide [ema Epar]

62. Gtpl7047

63. Zinc4321

64. Zonisamide (jp17/usp/inn)

65. Dtxsid9046023

66. Zonisamide [orange Book]

67. Bdbm10888

68. Hms2089o07

69. Hms2235l13

70. Hms3259n09

71. Hms3269f21

72. Hms3413l09

73. Hms3657e03

74. Hms3677l09

75. Hms3714e19

76. Hms3742m15

77. Hms3884i17

78. Zonisamide [usp Monograph]

79. Zonisamide 1.0 Mg/ml In Methanol

80. Bcp28480

81. Hy-b0124

82. Tox21_111569

83. Bbl010040

84. S1445

85. Stk711131

86. Akos001312269

87. Tox21_111569_1

88. Ac-1413

89. Ccg-220669

90. Cs-1888

91. Db00909

92. Ks-1142

93. Nc00637

94. 1,2-benzisoxazol-3-ylmethanesulfonamide

95. (1,2-benzoxazol-3-yl)methanesulfonamide

96. Ncgc00159319-03

97. Bz164593

98. Ft-0601524

99. Ft-0675931

100. Sw199135-2

101. Z0026

102. En300-50288

103. C07504

104. C76163

105. D00538

106. Ab00876297-09

107. Ab00876297-10

108. Ab00876297_11

109. Zonisamide Pound>>ci-912 Pound>>pd 110843

110. 291z974

111. A836085

112. Q219957

113. Q-201948

114. Sr-01000837537-2

115. Sr-01000837537-3

116. Sr-01000837537-8

117. Brd-k48300629-001-03-8

118. Z223042524

119. Zonisamide Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

120. Zon

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 212.23 g/mol
Molecular Formula C8H8N2O3S
XLogP30.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass212.02556330 g/mol
Monoisotopic Mass212.02556330 g/mol
Topological Polar Surface Area94.6 Ų
Heavy Atom Count14
Formal Charge0
Complexity298
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameZonegran
PubMed HealthZonisamide (By mouth)
Drug ClassesAnticonvulsant
Drug LabelZONEGRAN (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a mo...
Active IngredientZonisamide
Dosage FormCapsule
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyEisai

2 of 4  
Drug NameZonisamide
PubMed HealthZonisamide (By mouth)
Drug ClassesAnticonvulsant
Drug LabelZonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weigh...
Active IngredientZonisamide
Dosage FormCapsule
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyMylan Pharms; Wockhardt; Ani Pharms; Sun Pharm Inds (in); Apotex; Banner Pharmacaps; Invagen Pharms; Glenmark Generics; Zydus Pharms Usa; Mylan

3 of 4  
Drug NameZonegran
PubMed HealthZonisamide (By mouth)
Drug ClassesAnticonvulsant
Drug LabelZONEGRAN (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a mo...
Active IngredientZonisamide
Dosage FormCapsule
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyEisai

4 of 4  
Drug NameZonisamide
PubMed HealthZonisamide (By mouth)
Drug ClassesAnticonvulsant
Drug LabelZonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weigh...
Active IngredientZonisamide
Dosage FormCapsule
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyMylan Pharms; Wockhardt; Ani Pharms; Sun Pharm Inds (in); Apotex; Banner Pharmacaps; Invagen Pharms; Glenmark Generics; Zydus Pharms Usa; Mylan

4.2 Therapeutic Uses

Anticonvulsant

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1817


Zonisamide is indicated for adjunctive therapy use in the treatment of partial seizures in adults with epilepsy. /Included in US product labeling/

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2903


4.3 Drug Warning

Zonisamide (ZNS)-induced behavior disorders are reported in a 1-year-old girl and a 3-year-old boy. Both patients, who had no previous developmental or mental problems, displayed secondarily generalized motor seizures. Serum concentrations of ZNS were not high, 8.8 and 12.3 micrograms/ml (effective range 10-30 micrograms/ml) respectively. Although many cases of ZNS-related psychotic reactions and/or behavior disorders have been reported, all affected patients had complex partial seizures (CPS) and had received combination therapy with phenytoin (PHT). Thus, whether the disorders were induced only by ZNS, by an interaction between ZNS and PHT, or by CPS could not be determined. In the children reported, however, ZNS clearly induced behavior disorders at plasma ZNS levels within or even below the therapeutic range.

PMID:8156965 Kimura S; Epilepsia 35 (2): 403-5 (1994)


Oligohidrosis and Hyperthermia in Pediatric Patients: Oligohidrosis, sometimes resulting in heat stroke and hospitalization, is seen in association with zonisamide in pediatric patients. ... Decreased sweating and an elevation in body temperature above normal characterized these cases. Many cases were reported after exposure to elevated environmental temperatures. Heat stroke, requiring hospitalization, was diagnosed in some cases. There have been no reported deaths. Pediatric patients appear to be at an increased risk for zonisamide-associated oligohidrosis and hyperthermia. Patients, especially pediatric patients, treated with Zonegran should be monitored closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather. Caution should be used when zonisamide is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, carbonic anhydrase inhibitors and drugs with anticholinergic activity.

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1232


Fatalities resulting from severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred following use of zonisamide. Use of sulfonamides also rarely has caused fatalities resulting from fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias, regardless of the route of administration. Zonisamide should be discontinued immediately if signs or symptoms of hypersensitivity occur. Discontinuance of zonisamide should be considered whenever a patient receiving zonisamide develops unexplained rash; if the drug is not discontinued, the patient should be observed frequently.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2159


During the premarketing development of zonisamide, 9 sudden and unexplained deaths were reported among a cohort of 991 patients with epilepsy receiving adjunctive therapy with the drug (7.7 deaths per 1000 patient-years). Although the rate of these deaths exceeds that expected to occur in a healthy (nonepileptic) population, this rate was similar to that occurring in patients with refractory epilepsy not receiving zonisamide.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2159


For more Drug Warnings (Complete) data for ZONISAMIDE (22 total), please visit the HSDB record page.


4.4 Drug Indication

For use as adjunctive treatment of partial seizures in adults with epilepsy.


FDA Label


Zonegran is indicated as:

- monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;

- adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Zonisamide is a sulfonamide and therefore unrelated to other seizure medications. The mechanism is not know but it may block sodium and calcium channels. Blocking of these channels may prevent neuronal hypersynchronization. Sonisamide has also been found to potentiate dopaminergic and serotonergic neurotransmission but does not appear to potentiate syanptic activity by GABA (gamma amino butyric acid).


5.2 MeSH Pharmacological Classification

Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)


Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ZONISAMIDE
5.3.2 FDA UNII
459384H98V
5.3.3 Pharmacological Classes
Carbonic Anhydrase Inhibitors [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; P-Glycoprotein Inhibitors [MoA]; Sulfonamides [CS]; Anti-epileptic Agent [EPC]
5.4 ATC Code

N03AX15


N03AX15

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

N03 - Antiepileptics

N03A - Antiepileptics

N03AX - Other antiepileptics

N03AX15 - Zonisamide


5.5 Absorption, Distribution and Excretion

Absorption

The absorption is rapid with a time to peak concentration of 2.8-3.9 hours. Food has not effect on bioavailability.


Route of Elimination

Zonisamide is excreted primarily in urine as parent drug and as the glucuronide of a metabolite.


Volume of Distribution

1.45 L/kg


Clearance

0.30 - 0.35 mL/min/kg [patients not receiving enzyme-inducing antiepilepsy drugs (AEDs)]

0.35 - 0.5 mL/min/kg [Concomitant administration of phenytoin and carbamazepine]


Elimination: Renal: 62%, Fecal: 3%. Plasma clearance of zonisamide is approximately 0.30 to 0.35 mL/min/kg in patients not receiving concomitant therapy with enzyme-inducing anticonvulsants. Zonisamide clearance is increased to 0.5 mL/min/kg in patients concurrently receiving enzyme-inducing anticonvulsant medications.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2904


In patients with creatinine clearance <20 mL/min, the area under the concentration-time curve (AUC) for zonisamide is increased by 35%.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2904


Zonisamide is distributed to breast milk, cerebrospinal fluid, and erythrocytes. Concentration in erythrocytes is approximately 8 times higher than in plasma and the milk-to-plasma ratio is 0.93. The concentration of zonisamide in cerebrospinal fluid is approximately 76% of the concentration found in plasma.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2904


Following a 200-400 mg oral zonisamide dose, peak plasma concentrations (range: 2-5 ug/mL) in normal volunteers occur within 2-6 hours. In the presence of food, the time to maximum concentration is delayed, occurring at 4-6 hours, but food has no effect on the bioavailability of zonisamide. Zonisamide extensively binds to erythrocytes, resulting in an eight-fold higher concentration of zonisamide in red blood cells (RBC) than in plasma. The pharmacokinetics of zonisamide are dose proportional in the range of 200-400 mg, but the Cmax and AUC increase disproportionately at 800 mg, perhaps due to saturable binding of zonisamide to RBC. Once a stable dose is reached, steady state is achieved within 14 days. ...The apparent volume of distribution (V/F) of zonisamide is about 1.45 L/kg following a 400 mg oral dose. Zonisamide, at concentrations of 1.0-7.0 ug/mL, is approximately 40% bound to human plasma proteins. Protein binding of zonisamide is unaffected in the presence of therapeutic concentrations of phenytoin, phenobarbital or carbamazepine.

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1231


Zonisamide is excreted primarily in urine as parent drug and as the glucuronide of a metabolite. ... Of the excreted dose, 35% was recovered as zonisamide, 15% as N-acetyl zonisamide, and 50% as the glucuronide of 2-sulfamoylacetyl phenol (SMAP)

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1232


5.6 Metabolism/Metabolites

Primarily hepatic through cytochrome P450 isoenzyme 3A4 (CYP3A4). Undergoes acetylation and reduction, forming N-acetyl zonisamide, and the open-ring metabolite 2–sulfamoylacetyl phenol, respectively.


... Zonisamide is excreted primarily in urine as parent drug and as the glucuronide of a metabolite. ... Zonisamide undergoes acetylation to form N-acetyl zonisamide and reduction to form the open ring metabolite, 2-sulfamoylacetyl phenol (SMAP). Of the excreted dose, 35% was recovered as zonisamide, 15% as N-acetyl zonisamide, and 50% as the glucuronide of SMAP. Reduction of zonisamide to SMAP is mediated by cytochrome p450 isozyme 3A4 (CYP3A4). Zonisamide does not induce its own metabolism.

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1232


Zonisamide undergoes acetylation to form N-acetyl zonisamide and reduction to form the open ring metabolite, 2-sulfamoylacetyl phenol (SMAP). ... Reduction of zonisamide to SMAP is mediated by cytochrome P450 isozyme 3A4 (CYP3A4). Zonisamide does not induce its own metabolism.

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1231


5.7 Biological Half-Life

63 hours


Elimination /half-life/ in plasma: 63 hours; Elimination /half-life/ in erythrocytes: 105 hours.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2904


5.8 Mechanism of Action

Zonisamide binds to sodium channels and voltage sensitive calcium channels, which suppresses neuronal depolarization and hypersynchronization. Zonisamide also inhibits carbonic anhydrase to a weaker extent, but such an effect is not thought to contribute substantially to the drug's anticonvulsant activity.


The exact method by which zonisamide exerts its anticonvulsant effect is unknown. Some in vitro studies suggest a blockade of sodium channels, with consequent stabilization of neuronal membranes and suppression of neuronal hypersynchronization, whereas other in vitro studies have shown zonisamide to suppress synaptically-driven electrical activity without affecting postsynaptic GABA or glutamate responses. It appears then, that zonisamide dose not potentiate the synaptic activity of GABA. Zonisamide also serves as a weak inhibitor of carbonic anhydrase.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2903


Epileptiform discharges and behavioral seizures may be the consequences of excess excitation associated with the neurotransmitter glutamate, or from inadequate inhibitory effects associated with gamma-aminobutyric acid (GABA). Synaptic effects of these neurotransmitters are terminated by the action of transporter proteins that remove amino acids from the synaptic cleft. Excitation initiated by the synaptic release of glutamate is attenuated by the action of glial transporters glutamate-aspartate transporter (GLAST) and glutamate transporter-1 (GLT-1), and the neuronal transporter excitatory amino-acid carrier-1 (EAAC-1). GABA is removed from synaptic regions by the action of the transporters proteins GABA transporter-1 (GAT-1) and GABA transporter-3 (GAT-3). Albino rats with chronic, spontaneous recurrent seizures induced by the amygdalar injection of eCl3 were treated for 14 days with zonisamide (ZNS) (40 mg/kg, ip). Control animals underwent saline injection into the same amygdalar regions. Treatment control for both groups of intracerebrally injected animals was ip injection of equal volumes of saline. Western blotting was used to measure the quantity of glutamate and GABA transporters in hippocampus and frontal cortex. ZNS caused increase in the quantity of EAAC-1 protein in hippocampus and cortex and down regulation of the GABA transporter GAT-1. These changes occurred in both experimental and ZNS treated control animals. These data show that the molecular effect of ZNS, with up-regulation of EAAC-1 and decreased production of GABA transporters, should result in increased tissue and synaptic concentrations of GABA.

PMID:12941455 Ueda Y et al; Brain Res Mol Brain Res 116 (1-2): 1-6 (2003)


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Zonisamide (USP)

Date of Issue : 2023-12-28

Valid Till : 2026-12-28

Written Confirmation Number : WC-0310

Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase ll, Dahej, Dist-Bharuch, Gujarat

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04

PEGS Boston Summit
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PEGS Boston Summit
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Zonisamide (USP)

Date of Issue : 2022-06-07

Valid Till : 2025-06-25

Written Confirmation Number : WC-0057n

Address of the Firm : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat

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05

Hetero Drugs

India
PEGS Boston Summit
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Hetero Drugs

India
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Zonisamide (IH/USP)

Date of Issue : 2022-09-16

Valid Till : 2025-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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Zonisamide (IH)

Date of Issue : 2020-09-09

Valid Till : 2023-06-28

Written Confirmation Number : WC-0407

Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally bonthapally Village Jinnaram mandal med...

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PEGS Boston Summit
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Zonisamide IH/USP

Date of Issue : 2022-08-08

Valid Till : 2025-07-14

Written Confirmation Number : WC-0168

Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC, Industrial Zone, At & Post - Panoli, Dist....

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Listed Suppliers

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01

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

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Zonisamide

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

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

02

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

Zonisamide

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

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

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Digital Content Digital Content

Zonisamide

About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.
Cohance

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Digital Content Digital Content

Zonisamide

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
Jai Radhe Sales

05

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Zonisamide

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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06

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Zonisamide

About the Company : Gurvey & Berry offers an impressive lineup of bulk raw materials, but we are much more than products by the kilo or tonne. With 4 decades behind us, and our Service First philosoph...

Gurvey & Berry offers an impressive lineup of bulk raw materials, but we are much more than products by the kilo or tonne. With 4 decades behind us, and our Service First philosophy, we can make your ingredient procurement process easy. We’re here to help. From trusted manufacturers around the world, we source and supply about 200 products for our customers in the natural health, pharmaceutical, animal health & nutrition, food and cosmetics industries. Regulatory requirements, special orders, new products… let us help you.
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07

Hetero Drugs

India
PEGS Boston Summit
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Hetero Drugs

India
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Zonisamide

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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08

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Zonisamide

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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09

Noucor

Spain
PEGS Boston Summit
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Noucor

Spain
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Zonisamide

About the Company : NOUCOR, headquartered near Barcelona, is a forward-thinking chemical-pharmaceutical company with a rich history spanning nearly two centuries. We operate three specialized manufact...

NOUCOR, headquartered near Barcelona, is a forward-thinking chemical-pharmaceutical company with a rich history spanning nearly two centuries. We operate three specialized manufacturing plants: Urquima, dedicated to fine chemicals and active ingredient production, a pharmaceutical plant, and a facility exclusively for food supplements. Employing over 500 people, NOUCOR is driven by innovation, focusing on research, development, licensing, manufacturing, and supply of high-quality pharmaceutical products to meet global healthcare needs.
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10

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Zonisamide

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, antidepressants and mus...

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, antidepressants and muscle relaxants. Acquired by private equity groups in 2016, it is one of India’s leading manufacturers of psychotropic substances. It supplies over 60 APIs to customers in more than 62 countries from FDA and EU-approved locations. R L Fine Chem is a technology-driven company with a focus on the in-house manufacture of key intermediates for our APIs. The company currently operates out of four facilities in the Indian states of Karnataka and Andhra Pradesh.
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API Reference Price

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11-Jan-2021
30-Apr-2025
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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 20789

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DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 20789

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

USFDA APPLICATION NUMBER - 20789

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ABOUT THIS PAGE

Looking for 68291-97-4 / Zonisamide API manufacturers, exporters & distributors?

Zonisamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Zonisamide

Synonyms

68291-97-4, Zonegran, 1,2-benzisoxazole-3-methanesulfonamide, 1,2-benzoxazol-3-ylmethanesulfonamide, Exceglan, Excegram

Cas Number

68291-97-4

Unique Ingredient Identifier (UNII)

459384H98V

About Zonisamide

A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.

Zonisamide Manufacturers

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

Zonisamide Suppliers

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

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

Zonisamide USDMF

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

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

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

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

Zonisamide KDMF

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

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

After submitting a Zonisamide 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 Zonisamide API can apply through the Korea Drug Master File (KDMF).

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

Zonisamide WC

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

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

Zonisamide 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 Zonisamide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Zonisamide GMP

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

Zonisamide CoA

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

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

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