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    Chemistry

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    Also known as: 28721-07-5, Trileptal, Oxcarbamazepine, Oxcarbazepina, Oxcarbazepinum, Gp 47680
    Molecular Formula
    C15H12N2O2
    Molecular Weight
    252.27  g/mol
    InChI Key
    CTRLABGOLIVAIY-UHFFFAOYSA-N
    FDA UNII
    VZI5B1W380
    Oxcarbazepine
    A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.
    Oxcarbazepine is an Anti-epileptic Agent. The physiologic effect of oxcarbazepine is by means of Decreased Central Nervous System Disorganized Electrical Activity.
    1 2D Structure

    Oxcarbazepine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-oxo-6H-benzo[b][1]benzazepine-11-carboxamide
    2.1.2 InChI
    InChI=1S/C15H12N2O2/c16-15(19)17-12-7-3-1-5-10(12)9-14(18)11-6-2-4-8-13(11)17/h1-8H,9H2,(H2,16,19)
    2.1.3 InChI Key
    CTRLABGOLIVAIY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1C2=CC=CC=C2N(C3=CC=CC=C3C1=O)C(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    VZI5B1W380
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 10,11-dihydro-10-oxo-5h-dibenz(b,f)azepine-5-carboxamide

    2. Gp 47680

    3. Timox

    4. Trileptal

    2.3.2 Depositor-Supplied Synonyms

    1. 28721-07-5

    2. Trileptal

    3. Oxcarbamazepine

    4. Oxcarbazepina

    5. Oxcarbazepinum

    6. Gp 47680

    7. 10-oxo-10,11-dihydro-5h-dibenzo[b,f]azepine-5-carboxamide

    8. 5-oxo-6h-benzo[b][1]benzazepine-11-carboxamide

    9. Kin-493

    10. Gp-47680

    11. Oxtellar Xr

    12. 10,11-dihydro-10-oxo-5h-dibenz(b,f)azepine-5-carboxamide

    13. 10,11-dihydro-10-oxo-5h-dibenz[b,f]azepine-5-carboxamide

    14. Spn-804

    15. 5h-dibenz[b,f]azepine-5-carboxamide, 10,11-dihydro-10-oxo-

    16. Mls000084586

    17. 9-oxo-2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaene-2-carboxamide

    18. 5h-dibenz(b,f)azepine-5-carboxamide, 10,11-dihydro-10-oxo-

    19. Nsc-758693

    20. Chembl1068

    21. Smr000048684

    22. Chebi:7824

    23. Vzi5b1w380

    24. Timox

    25. Ncgc00065934-02

    26. Oxcarbazepine [inn]

    27. Dsstox_cid_25703

    28. Dsstox_rid_81075

    29. Dsstox_gsid_45703

    30. Oxcarbazepinum [inn-latin]

    31. Oxcarbazepina [inn-spanish]

    32. Oxcarbazepime

    33. Epilexter

    34. Epliga

    35. Trileptal (tn)

    36. Cas-28721-07-5

    37. Sr-01000612612

    38. Einecs 249-188-8

    39. Unii-vzi5b1w380

    40. Oxcarbazepin

    41. Hsdb 7524

    42. Oxtellar (tn)

    43. Oxcarbazepine [usan:usp:inn:ban]

    44. Mfcd00865307

    45. Ocbz

    46. Oxcarbazepine Solution

    47. Oxcarbazepine- Bio-x

    48. Spectrum_001675

    49. Opera_id_818

    50. Regid866068

    51. Spectrum2_000483

    52. Spectrum3_001669

    53. Spectrum4_000634

    54. Spectrum5_001869

    55. O0363

    56. Oxcarbazepine [mi]

    57. Oxcarbazepine [jan]

    58. Oxcarbazepine [hsdb]

    59. Oxcarbazepine [usan]

    60. Schembl35129

    61. Bspbio_003457

    62. Kbiogr_001248

    63. Kbioss_002155

    64. Oxcarbazepine [vandf]

    65. Cid_34312

    66. Mls000759520

    67. Mls001201742

    68. Mls001424025

    69. Mls006011855

    70. Bidd:gt0078

    71. Oxcarbazepine [mart.]

    72. Spectrum1504243

    73. Spbio_000345

    74. Oxcarbazepine [usp-rs]

    75. Oxcarbazepine [who-dd]

    76. Gtpl7254

    77. Oxcarbazepine (jan/usp/inn)

    78. Zinc4724

    79. Dtxsid0045703

    80. Bdbm34179

    81. Kbio2_002155

    82. Kbio2_004723

    83. Kbio2_007291

    84. Kbio3_002677

    85. Oxcarbazepine, Analytical Standard

    86. 10,11-dihydro-10-oxo-5h-dibenzo[b,f]azepine-5-carboxamide

    87. Hms1922h17

    88. Hms2051o04

    89. Hms2090f13

    90. Hms2093e10

    91. Hms2231b12

    92. Hms3369j22

    93. Hms3393o04

    94. Hms3657o11

    95. Hms3713i10

    96. Hms3884k13

    97. Pharmakon1600-01504243

    98. Oxcarbazepine [orange Book]

    99. Bcp28260

    100. Bcp33398

    101. Hy-b0114

    102. Oxcarbazepine [ep Monograph]

    103. Tox21_110983

    104. Ccg-39509

    105. Nsc758693

    106. Oxcarbazepine [usp Monograph]

    107. S1391

    108. Stk594696

    109. Akos005516529

    110. Tox21_110983_1

    111. Ac-3483

    112. Cs-1869

    113. Db00776

    114. Ks-5197

    115. Nc00088

    116. Nsc 758693

    117. Oxcarbazepine, >=98% (hplc), Solid

    118. Ncgc00065934-03

    119. Ncgc00065934-04

    120. Ncgc00065934-05

    121. Ncgc00065934-06

    122. Bo164187

    123. Sbi-0206772.p001

    124. Gp-47-680

    125. Am20040094

    126. Ft-0630543

    127. Ft-0673414

    128. Sw197468-3

    129. A13943

    130. C07492

    131. D00533

    132. M06310

    133. Ab00393017-12

    134. Ab00393017-14

    135. Ab00393017_15

    136. Ab00393017_16

    137. 721o075

    138. Q176301

    139. Sr-01000612612-4

    140. Sr-01000612612-6

    141. W-107033

    142. Brd-k04196797-001-12-9

    143. 10-oxo-10,11-dihydro-5h-dibenz(b,f)azepin-5-carboxamide

    144. 5-carbamoyl-10-oxo-10,11-dihydro-5h-dibenz[b,f]azepine

    145. 10,11-dihydro-10-oxo-5h-dibenz[b,f]azepin-5-carbonsaeureamid

    146. 10-oxo-10,11-dihydro-5h-dibenzo[b,f]azepine-5-carboxamide #

    147. Oxcarbazepine, European Pharmacopoeia (ep) Reference Standard

    148. 10,11-dihydro-10-oxo-5h-dibenzo(z)[b,f]azepine-5-carboxamide

    149. Oxcarbazepine, United States Pharmacopeia (usp) Reference Standard

    150. 10-oxo Carbazepine; Oxecarb; 10,11-dihdyro-10-oxo-5h-dibenz[b,f]azepine-5-carboxamide

    151. Oxcarbazepine, Pharmaceutical Secondary Standard; Certified Reference Material

    152. Oxcarbazepine Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    153. Oxcarbazepine-13c6 Solution, 100 Mug/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 252.27 g/mol
    Molecular Formula C15H12N2O2
    XLogP31.7
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count0
    Exact Mass252.089877630 g/mol
    Monoisotopic Mass252.089877630 g/mol
    Topological Polar Surface Area63.4 Ų
    Heavy Atom Count19
    Formal Charge0
    Complexity382
    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 6  
    Drug NameOxcarbazepine
    PubMed HealthOxcarbazepine (By mouth)
    Drug ClassesAnticonvulsant
    Drug LabelOxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula isOxcarbazepine is a whit...
    Active IngredientOxcarbazepine
    Dosage FormTablet; Suspension
    RouteOral
    Strength150mg; 600mg; 300mg; 300mg/5ml
    Market StatusPrescription
    CompanyAmneal Pharms; Ranbaxy; Breckenridge Pharm; Apotex; Sun Pharm Inds; Taro; Roxane; Glenmark Generics; Cadista Pharms

    2 of 6  
    Drug NameOxtellar xr
    Drug LabelOxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is...
    Active IngredientOxcarbazepine
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 600mg; 300mg
    Market StatusPrescription
    CompanySupernus Pharms

    3 of 6  
    Drug NameTrileptal
    PubMed HealthOxcarbazepine (By mouth)
    Drug ClassesAnticonvulsant
    Drug LabelTrileptal is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Trileptal is also available as a 300 mg/5 mL (60mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepi...
    Active IngredientOxcarbazepine
    Dosage FormTablet; Suspension
    RouteOral
    Strength150mg; 600mg; 300mg; 300mg/5ml
    Market StatusPrescription
    CompanyNovartis

    4 of 6  
    Drug NameOxcarbazepine
    PubMed HealthOxcarbazepine (By mouth)
    Drug ClassesAnticonvulsant
    Drug LabelOxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula isOxcarbazepine is a whit...
    Active IngredientOxcarbazepine
    Dosage FormTablet; Suspension
    RouteOral
    Strength150mg; 600mg; 300mg; 300mg/5ml
    Market StatusPrescription
    CompanyAmneal Pharms; Ranbaxy; Breckenridge Pharm; Apotex; Sun Pharm Inds; Taro; Roxane; Glenmark Generics; Cadista Pharms

    5 of 6  
    Drug NameOxtellar xr
    Drug LabelOxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is...
    Active IngredientOxcarbazepine
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 600mg; 300mg
    Market StatusPrescription
    CompanySupernus Pharms

    6 of 6  
    Drug NameTrileptal
    PubMed HealthOxcarbazepine (By mouth)
    Drug ClassesAnticonvulsant
    Drug LabelTrileptal is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Trileptal is also available as a 300 mg/5 mL (60mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepi...
    Active IngredientOxcarbazepine
    Dosage FormTablet; Suspension
    RouteOral
    Strength150mg; 600mg; 300mg; 300mg/5ml
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Oxcarbazepine is indicated for monotherapeutic or adjunctive therapeutic use in the treatment of partial seizures in adults and children ages 4 to 16 with epilepsy. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2234

    /EXPL THER:/ ... Oxcarbazepine /was compared/ with acamprosate in relapse prevention in recently withdrawn alcohol-dependent patients. /They/ investigated the efficacy and safety of oxcarbazepin (vs acamprosate) by conducting a 24-week randomized, parallel-group, open-label, clinical trial on 30 acutely detoxified alcoholic patients. Survival analyses (Kaplan-Meier) were performed to look for evidence of a longer "survival" of patients receiving oxcarbazepine. ... After withdrawal, time to severe relapse and time to first consumption of any ethanol by oxcarbazepin patients were not longer than for acamprosate patients. Abstinent patients in both study groups showed a significantly lower obsessive compulsive drinking scale-German version (OCDS-G) than relapsed patients. No undesired effects occurred when oxcarbazepin patients consumed alcohol. ... It is noteworthy that oxcarbazepine is well tolerated, even when alcohol is on board. ...

    PMID:16573580 Croissant B et al; Alcohol Clin Exp Res 30 (4): 630-5 (2006)

    /EXPL THER:/ ... Data related to 150 patients harboring supratentorial brain gliomas with the aim to assess the efficacy of oxcarbazepine in preventing the occurrence or the recurrence of early postoperative seizures and its tolerability when it is rapidly titrated /was analyzed/. Only four patients (2.7%) experienced seizures within the first week after surgery. Patients did not report disturbances during the titration phase. Regarding adverse events in the first week, six patients (4%) showed minor skin rash. Persistent symptomatic hyponatremia never occurred. ... Oxcarbazepine can be a good alternative to traditional antiepileptic agents in the prevention of perioperative seizures being efficacy, ease of use (rapid titration in 3 days, not requiring close plasma concentration monitoring) and good tolerability (no major side effects during titration and during the first postoperative week) the key factors. Moreover, oxcarbazepine can be a valid choice when long-term therapy is required because of the low interaction with other drugs and the low hematological side effects.

    PMID:16944312 Mauro AM et al; J Neurooncol 81 (3): 279-85 (2007)

    4.3 Drug Warning

    Multiorgan hypersensitivity reactions occurring days to weeks or months (range 4-60 days) after initiation of oxcarbazepine therapy have been reported in adults and pediatric patients. Although these reactions have been reported rarely, many of these patients required hospitalization, and some reactions were considered life-threatening. Manifestations may include (but are not limited to) fever, rash, lymphadenopathy, hepatitis, abnormal liver function test results, eosinophilia, thrombocytopenia, neutropenia, pruritus, nephritis, oliguria, hepatorenal syndrome, arthralgia, and asthenia.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2245

    While severe hyponatremia is reported to be more frequent in adults treated with oxcarbazepine than with carbamazepine, there is not sufficient data about the incidence of hyponatremia in childhood during treatment with oxcarbazepine. ... Changes in serum electrolyte balance in 75 children with epilepsy before and during treatment with oxcarbazepine and after replacing carbamazepine therapy with oxcarbazepine therapy /were evaluate/. All patients had normal sodium serum levels at the onset of oxcarbazepine. During treatment with oxcarbazepine ... hyponatremia (Na +< 135 mmol/L) without clinical symptoms /were found/ in 26.6 % of the children (n = 20), /and/ sodium levels below 125 mmol/L were observed in 2 children (2.6 %). Clinically relevant hyponatremia occurred in one girl only (1.3 %). In a subgroup of 27 children, in whom carbamazepine was directly replaced with oxcarbazepine, hyponatremia without symptoms was found in one child under carbamazepine (3.7 %) and in six children under oxcarbazepine (22.2 %). Dosage of oxcarbazepine, serum levels of the active metabolite of oxcarbazepine, antiepileptic comedication or patients' age and gender were of no predictive value for the development of hyponatremia. ...

    PMID:12571784 Holtmann M et al; Neuropediatrics 33 (6): 298-300 (2002)

    Adverse effects occurring in 5% or more of patients and more frequently than placebo include dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2246

    Serious dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in adults and children receiving oxcarbazepine; reactions have been life-threatening, have required hospitalization, and rarely have been fatal. The incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis reported in patients receiving oxcarbazepine exceeds the rate in the general population by threefold to tenfold. The median time to onset of these reactions was 19 days. Recurrence of serious dermatologic reactions following rechallenge with oxcarbazepine has occurred.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2245

    For more Drug Warnings (Complete) data for OXCARBAZEPINE (11 total), please visit the HSDB record page.

    4.4 Drug Indication

    In the United States, oxcarbazepine is indicated as monotherapy in the treatment of partial-onset seizures in patients 4 years of age and older, and as adjunctive therapy in the treatment of partial-onset seizures in patients 2 years of age and older. In Canada, oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 6 years of age and older.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Oxcarbazepine is an anticonvulsant drug that reduces the incidence of seizures in epilepsy by inhibiting abnormal electrical activity in the brain. There have been rare reports of oxcarbazepine resulting in the development of hematologic abnormalities, including agranulocytosis and aplastic anemia. Patients should be undergo frequent laboratory testing and should be monitored closely for signs and symptoms of blood dyscrasias. Oxcarbazepine has also been associated with the development of dermatologic reactions which can progress from a simple rash to potentially fatal reactions such as toxic epidermal necrolysis (TEN) or Stevens-Johnson Syndrome (SJS). Patients with the HLA-A*3101 and/or HLA-B*1502 alleles may be at higher risk of this reaction. Oxcarbazepine should be discontinued at the first sign of a drug-induced skin reaction.

    5.2 MeSH Pharmacological Classification

    Anticonvulsants

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

    Cytochrome P-450 CYP3A Inducers

    Drugs and compounds that induce the synthesis of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inducers.)

    Voltage-Gated Sodium Channel Blockers

    A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    OXCARBAZEPINE
    5.3.2 FDA UNII
    VZI5B1W380
    5.3.3 Pharmacological Classes
    Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]
    5.4 ATC Code

    N - Nervous system

    N03 - Antiepileptics

    N03A - Antiepileptics

    N03AF - Carboxamide derivatives

    N03AF02 - Oxcarbazepine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oxcarbazepine is completely absorbed following oral administration. A single 600mg dose of oxcarbazepine resulted in an MHD Cmax of 34 mol/L and a median Tmax of 4.5 hours. When administered twice daily, steady-state levels of MHD are attained within 2-3 days. The rate and extent of absorption of oxcarbazepine is not affected by food intake.

    Route of Elimination

    Following oral administration, more than 95% of the administered dose of oxcarbazepine is found in the urine. Of this, approximately 49% is MHD glucuronide metabolites, 27% is unchanged MHD, 3% is inactive DHD metabolites, 13% is conjugated oxcarbazepine, and less than 1% is unchanged parent drug. Fecal elimination accounts for only 4% of the administered dose.

    Volume of Distribution

    The apparent volume of distribution of oxcarbazepine is 49 L. The apparent volumes of distribution of (S)- and (R)-MHD were found to be 23.6 L and 31.7 L, respectively.

    Clearance

    Plasma clearance of oxcarbazepine has been estimated to be approximately 84.9 L/h, whereas plasma clearance of its active metabolite, MHD, was estimated to be 2.0 L/h. Rapid metabolic clearance appears to be the main pathway for oxcarbazepine, while clearance of its metabolites occurs mainly via renal excretion.

    Oxcarbazepine is completely absorbed. Food does not alter the rate and extent of absorption of oxcarbazepine.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2235

    Both oxcarbazepine and its active 10-monohydroxy metabolite (MHD) are distributed into milk in humans.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2246

    Elimination: Renal: greater than 95%, with more than 99% of the dose excreted in the form of metabolites. Fecal: less than 4%.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2235

    Oxcarbazepine is an antiepileptic drug with a chemical structure similar to carbamazepine, but with different metabolism. Oxcarbazepine is rapidly reduced to 10,11-dihydro-10-hydroxy-carbazepine (monohydroxy derivative, MHD), the clinically relevant metabolite of oxcarbazepine. MHD has (S)-(+)- and the (R)-(-)-enantiomer, but the pharmacokinetics of the racemate are usually reported. The bioavailability of the oral formulation of oxcarbazepine is high (>95%). It is rapidly absorbed after oral administration, reaching peak concentrations within about 1-3 hours after a single dose, whereas the peak of MHD occurs within 4-12 hours. At steady state, the peak of MHD occurs about 2-4 hours after drug intake. The plasma protein binding of MHD is about 40%. Cerebrospinal fluid concentrations of MHD are in the same range as unbound plasma concentrations of MHD. Oxcarbazepine can be transferred significantly through the placenta in humans. Oxcarbazepine and MHD exhibit linear pharmaco-kinetics and no autoinduction occurs. ...

    PMID:12959634 May TW et al; Clin Pharmacokinet 42 (12): 1023-42 (2003)

    For more Absorption, Distribution and Excretion (Complete) data for OXCARBAZEPINE (9 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Oxcarbazepine is rapidly and extensively metabolized to its primary metabolite, MHD, which is responsible for the bulk of its anti-epileptic activity and exists in much higher concentrations in the plasma than the parent drug. MHD is formed via reduction by several members of the aldo-keto reductase family of cytosolic liver enzymes and exists as a racemate in plasma in an approximate ratio of 80% (S)-MHD to 20% (R)-MHD. MHD is further metabolized to glucuronide conjugate metabolites for excretion, and small amounts are oxidized to 10-,11-dihydro-10,11-dihydroxycarbamazepine (DHD) which is pharmacologically inactive. Only 10% of an administered dose of oxcarbazepine will remain as either the parent drug or glucuronide conjugates of the parent drug.

    Oxcarbazepine is rapidly reduced by cytosolic enzymes in the liver to its 10-monohydroxy metabolite, MHD, which is primarily responsible for the pharmacological effect of Trileptal. MHD is metabolized further by conjugation with glucuronic acid. Minor amounts (4% of the dose) are oxidized to the pharmacologically inactive 10,11-dihydroxy metabolite (DHD). Oxcarbazepine is cleared from the body mostly in the form of metabolites which are predominantly excreted by the kidneys. More than 95% of the dose appears in the urine, with less than 1% as unchanged oxcarbazepine. Fecal excretion accounts for less than 4% of the administered dose. Approximately 80% of the dose is excreted in the urine either as glucuronides of MHD (49%) or as unchanged MHD (27%); the inactive DHD accounts for approximately 3% and conjugates of MHD and oxcarbazepine account for 13% of the dose.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2300

    The disposition of the new anti-epileptic agent oxcarbazepine (10,11-dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide) has been studied in two healthy volunteers following an oral 400 mg dose of (14)C-labelled drug. The dose was excreted almost completely in the urine (94.6 and 97.1%) within six days. Fecal excretion amounted to 4.3 and 1.9% of the dose in the two subjects. In the 0-6 days urine samples the biotransformation products have been isolated and identified. 10,11-Dihydro-10-hydroxycarbamazepine (GP 47,779) and its two diastereoisomeric O-glucuronides were found as main metabolites. Taken together, they accounted for 79% of urinary (14)C. Unchanged oxcarbazepine, and its sulfate and glucuronide conjugates were isolated in smaller amounts only (13%). Other minor metabolites were the trans- and cis-isomers of 10,11-dihydro-10,11-dihydroxy-carbamazepine (approximately 4%), and a phenolic derivative of GP 47,779 (less than 1%). The biotransformation of oxcarbazepine proceeds mainly by reduction to GP 47,779, and subsequent conjugation with glucuronic acid. Reduction is stereospecific, favoring the S-configuration of GP 47,779. Direct conjugation of oxcarbazepine, in the enol form, is a minor pathway. Oxidative reactions are unimportant.

    PMID:3765657 Schutz H et al; Xenobiotica 16 (8): 769-78 (1986)

    ... The interaction potential of oxcarbazepine is relatively low. However, enzyme-inducing antiepileptic drugs such as phenytoin, phenobarbital or carbamazepine can reduce slightly the concentrations of 10,11-dihydro-10-hydroxy-carbazepine (monohydroxy derivative, MHD). Verapamil may moderately decrease MHD concentrations, but this effect is probably without clinical relevance. The influence of oxcarbazepine on other antiepileptic drugs is not clinically relevant in most cases. However, oxcarbazepine appears to increase concentrations of phenytoin and to decrease trough concentrations of lamotrigine and topiramate. Oxcarbazepine lowers concentrations of ethinylestradiol and levonorgestrel, and women treated with oxcarbazepine should consider additional contraceptive measures. Due to the absent or lower enzyme-inducing effect of oxcarbazepine, switching from carbamazepine to oxcarbazepine can result in increased serum concentrations of comedication, sometimes associated with adverse effects. ...

    PMID:12959634 May TW et al; Clin Pharmacokinet 42 (12): 1023-42 (2003)

    5.7 Biological Half-Life

    The plasma half-life of oxcarbazepine is approximately 2 hours and the plasma half-life of MHD is approximately 9 hours.

    Oxcarbazepine: 2 hours. 10-Monohydroxy metabolite: 9 hours. Note: In patients with renal function impairment with a creatinine clearance < 30 mL/minute, the half life of 10 monohydroxy metabolite is prolonged to 10 hours ...

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2235

    ... Elimination half-lives in healthy volunteers are 1-5 hours for oxcarbazepine and 7-20 hours for 10,11-dihydro-10-hydroxy-carbazepine (monohydroxy derivative, MHD). Longer and shorter elimination half-lives have been reported in elderly volunteers and children, respectively. ...

    PMID:12959634 May TW et al; Clin Pharmacokinet 42 (12): 1023-42 (2003)

    5.8 Mechanism of Action

    The exact mechanism through which oxcarbazepine and its active metaoblite, MHD, exert their anti-epileptic effects is unclear, but is thought to primarily involve the blockade of voltage-gated sodium channels. The opening and closing of sodium channels allows for the propagation of action potentials along neurons - in epilepsy, these action potentials can occur in excess of that required for normal function, and the repetitive and pathological firing of these action potentials leads to seizure activity. Both oxcarbazepine and MHD are thought to inhibit seizure activity by binding to the inactive state of voltage-gated sodium channels, thus prolonging the period in which the receptor is unavailable for action potential propagation. This helps to stabilize hyperexcited neuronal membranes, inhibit repetitive neuron firing, and prevent the spread of seizure activity within the CNS without affecting normal neuronal transmission. Increased potassium conductance and modulation of voltage-activated calcium channels is also thought to play a role in the anti-seizure activity of oxcarbazepine. Inhibition of glutamatergic activity was thought to contribute to oxcarbazepine's activity, but this effect could not be replicated _in vivo_.

    The pharmacological activity of Trileptal (oxcarbazepine) is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2300

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    06-Jan-2022
    14-Nov-2025
    KGS
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    Drugs in Development

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    • Development Update
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    • WHO-GMP
    Virtual BoothAucta is a global brand that creates better products from proven molecules.

    Aucta Announced FDA Approval of A Generic Version of Trileptal®(oxcarbazepine) Oral Suspension

    Details:

    Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat partial seizures.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Trileptal-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2022

    Aucta Company Banner

    01

    Aucta Pharmaceuticals

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAucta is a global brand that creates better products from proven molecules.

    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aucta Announced FDA Approval of A Generic Version of Trileptal®(oxcarbazepine) Oral Suspension

    Details : Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat parti...

    Product Name : Trileptal-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 05, 2022

    Aucta Company Banner

    Stock Recap
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    Virtual Booth

    • Development Update
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lupin receives tentative US FDA approval for Oxcarbazepine ER tablets

    Details:

    Oxtellar XR-Generic (oxcarbazepine) is an antiepileptic drug (AED) indicated for the treatment of partial-onset seizures in patients aged six years and older.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Oxtellar XR-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 09, 2025

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    Lupin Ltd

    India
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    CPhI Milan
    Exhibiting
    • fda
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    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin receives tentative US FDA approval for Oxcarbazepine ER tablets

    Details : Oxtellar XR-Generic (oxcarbazepine) is an antiepileptic drug (AED) indicated for the treatment of partial-onset seizures in patients aged six years and older.

    Product Name : Oxtellar XR-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 09, 2025

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    • Development Update
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    USFDA Gives Final Nod to Zydus’ Tablets for Treatment of Seizures

    Details:

    Oxcarbazepine tablets produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat partial seizures.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Trileptal-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 04, 2023

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    03

    Zydus Lifesciences

    India
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    BIO Partnering at JPM
    Not Confirmed

    Zydus Lifesciences

    India
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    USFDA Gives Final Nod to Zydus’ Tablets for Treatment of Seizures

    Details : Oxcarbazepine tablets produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to tre...

    Product Name : Trileptal-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 04, 2023

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    A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

    Details:

    Padsevonil is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.


    Lead Product(s): Padsevonil,Oxcarbazepine,Levetiracetam,Lamotrigine,Brivaracetam

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 03, 2018

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    04

    UCB Pharma S.A

    Belgium
    arrow
    BIO Partnering at JPM
    Not Confirmed

    UCB Pharma S.A

    Belgium
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Padsevonil,Oxcarbazepine,Levetiracetam,Lamotrigine,Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability o...

    Details : Padsevonil is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 03, 2018

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    Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

    Details:

    Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bipolar Disorder.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Massachusetts General Hospital

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 26, 2018

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    05

    Collaborative Care Initiative, LLC

    Country
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Collaborative Care Initiative, LLC

    Country
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Massachusetts General Hospital

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

    Details : Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bipolar Disorder.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 26, 2018

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    Protective Role of Oxcarbazepine in Multiple Sclerosis

    Details:

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


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: National Multiple Sclerosis Society | Novartis Pharmaceuticals Corporation | Barts & The London NHS Trust | University College, London | Royal Free Hospital NHS FT | Mid and South Essex NHS FT | St George's Healthcare NHS Trust | Barnet and Chase Farm Hos

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 04, 2014

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    06

    Queen Mary University of London

    Country
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Queen Mary University of London

    Country
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : National Multiple Sclerosis Society | Novartis Pharmaceuticals Corporation | Barts & The London NHS Trust | University College, London | Royal Free Hospital NHS FT | Mid and South Essex NHS FT | St George's Healthcare NHS Trust | Barnet and Chase Farm Hos

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Protective Role of Oxcarbazepine in Multiple Sclerosis

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

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 04, 2014

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    Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

    Details:

    Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Seizures.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 10, 2012

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    07

    Hikma Pharmaceuticals

    United Kingdom
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Hikma Pharmaceuticals

    United Kingdom
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

    Details : Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Seizures.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 10, 2012

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    Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

    Details:

    Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Seizures.


    Lead Product(s): Oxcarbazepine,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 08, 2012

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    08

    Hikma Pharmaceuticals

    United Kingdom
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Hikma Pharmaceuticals

    United Kingdom
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Oxcarbazepine,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

    Details : Oxcarbazepine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Seizures.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 08, 2012

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    Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

    Details:

    BIA 2-093 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.


    Lead Product(s): Eslicarbazepine Acetate,Oxcarbazepine

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 05, 2012

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    09

    Bial

    Portugal
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Bial

    Portugal
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Eslicarbazepine Acetate,Oxcarbazepine

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in H...

    Details : BIA 2-093 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 05, 2012

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    Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

    Details:

    BIA 2-093 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.


    Lead Product(s): Eslicarbazepine Acetate,Oxcarbazepine

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 05, 2012

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    10

    Bial

    Portugal
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Bial

    Portugal
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Eslicarbazepine Acetate,Oxcarbazepine

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

    Details : BIA 2-093 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 05, 2012

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    Only 10 entries up to this point, click to access all click full view read-more
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    INTERMEDIATE SUPPLIERS

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    01

    Amara Labs

    India
    Biotech Showcase
    Not Confirmed
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    Amara Labs

    India
    Biotech Showcase
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    10-METHOXYIMINOSTILBENE (MIS)

    CAS Number : 4698-11-7

    End Use API : Oxcarbazepine

    About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...

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    02

    Maisuriya Pharma Solutions

    India
    Biotech Showcase
    Not Confirmed
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    Maisuriya Pharma Solutions

    India
    Biotech Showcase
    Not Confirmed
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    10-methoxy Iminostilbene

    CAS Number : 4698-11-7

    End Use API : Oxcarbazepine

    About The Company : Maisuriya Pharma Solutions is a research-driven & technology-oriented company. Continuous innovations & improvement are the lifeblood of our business. Our major...

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    03

    Sagar Life Sciences

    India
    Biotech Showcase
    Not Confirmed
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    Sagar Life Sciences

    India
    Biotech Showcase
    Not Confirmed
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    Iminostilbene

    CAS Number : 256-96-2

    End Use API : Oxcarbazepine

    About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

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    04

    Sagar Life Sciences

    India
    Biotech Showcase
    Not Confirmed
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    Sagar Life Sciences

    India
    Biotech Showcase
    Not Confirmed
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    Para Fluoro Phenol

    CAS Number : 371-41-5

    End Use API : Oxcarbazepine

    About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

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    05

    Shivam Petrochem Industries

    India
    Biotech Showcase
    Not Confirmed
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    Shivam Petrochem Industries

    India
    Biotech Showcase
    Not Confirmed
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    10-Methoxy-Iminostilbene (10-MIS)

    CAS Number : 4698-11-7

    End Use API : Oxcarbazepine

    About The Company : Shivam Petrochem Industries was founded with the aim of meeting the needs of pharmaceutical companies by offering tailored solutions. As an ISO 9001:2015 certif...

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    06

    Zhejiang Jiuzhou Pharmaceutical

    China
    Biotech Showcase
    Not Confirmed
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    Zhejiang Jiuzhou Pharmaceutical

    China
    Biotech Showcase
    Not Confirmed
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    10-Methoxy Iminostilbene (10-MISB)

    CAS Number : 4698-11-7

    End Use API : Oxcarbazepine

    About The Company : Zhejiang Jiuzhou Pharmaceutical Co., Ltd. is a medium-scale private enterprise, which focuses in the production of APIs. Our company grows out of Dongshan Chemi...

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

    Europe

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    01

    Towa Pharmaceutical Sa

    Japan
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    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Regulatory Info : Authorized

    Registration Country : Spain

    Oxcarbazepine

    Brand Name : Oxcarbazepine Pensa

    Dosage Form : Film Coated Tablet

    Dosage Strength : 300MG

    Packaging :

    Approval Date : 2013-07-23

    Application Number : 77769

    Regulatory Info : Authorized

    Registration Country : Spain

    Towa Pharmaceutical

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    02

    Towa Pharmaceutical Sa

    Japan
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Regulatory Info : Authorized

    Registration Country : Spain

    Oxcarbazepine

    Brand Name : Oxcarbazepine Pensa

    Dosage Form : Film Coated Tablet

    Dosage Strength : 600MG

    Packaging :

    Approval Date : 2013-07-17

    Application Number : 77761

    Regulatory Info : Authorized

    Registration Country : Spain

    Towa Pharmaceutical

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    03

    Novartis Norge (2)

    Switzerland
    BIO Partnering at JPM
    Not Confirmed
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    Novartis Norge (2)

    Switzerland
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    BIO Partnering at JPM
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Okskarbazepin

    Brand Name : Trileptal

    Dosage Form : Tablet, film-coated

    Dosage Strength : 150 mg

    Packaging : Blisterpakning 100item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    04

    Novartis Pharmaceuticals Sa

    Switzerland
    BIO Partnering at JPM
    Not Confirmed
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    Novartis Pharmaceuticals Sa

    Switzerland
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    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Oxcarbazepine

    Brand Name : Trileptal

    Dosage Form : Oral Suspension

    Dosage Strength : 60MG

    Packaging :

    Approval Date : 2001-11-23

    Application Number : 64398

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Orifarm AS

    Denmark
    BIO Partnering at JPM
    Not Confirmed
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    Orifarm AS

    Denmark
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    BIO Partnering at JPM
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    Regulatory Info :

    Registration Country : Norway

    Oxcarbazepine

    Brand Name : Trileptal

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 150 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Orifarm Ab

    Denmark
    BIO Partnering at JPM
    Not Confirmed
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    Orifarm Ab

    Denmark
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    BIO Partnering at JPM
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Oxcarbazepine

    Brand Name : Trileptal

    Dosage Form : Film Coated Tablet

    Dosage Strength : 300mg

    Packaging :

    Approval Date : 21/04/2020

    Application Number : 20190415000086

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    07

    Orifarm Ab

    Denmark
    BIO Partnering at JPM
    Not Confirmed
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    Orifarm Ab

    Denmark
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Oxcarbazepine

    Brand Name : Trileptal

    Dosage Form : Oral Suspension

    Dosage Strength : 60mg/ml

    Packaging :

    Approval Date : 01/09/2010

    Application Number : 20100429000071

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    08

    Orifarm Ab

    Denmark
    BIO Partnering at JPM
    Not Confirmed
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    Orifarm Ab

    Denmark
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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Oxcarbazepine

    Brand Name : Trileptal

    Dosage Form : Film Coated Tablet

    Dosage Strength : 600mg

    Packaging :

    Approval Date : 08/02/2017

    Application Number : 20160504000082

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Oxcarbazepine

    Brand Name : ZIGABAL

    Dosage Form : Tablets

    Dosage Strength : 300 mg

    Packaging : 50 UNITS 300 MG - ORAL USE

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    Registration Country : Italy

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    Regulatory Info : Deregistered

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    Oxcarbazepine

    Brand Name : Oxcarbazepine Teva

    Dosage Form : Film Coated Tablet

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 30/10/2009

    Application Number : 20080111000025

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    DOSAGE - TABLET;ORAL - 150MG

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    Oxcarbazepine API needed in India [ENA23903]
    A company that focuses on the development and manufacturing of various liquids, ointments and personal care products is looking for suppliers of Oxcarbazepine API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    30 Aug 2025

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    30 Aug 2025

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    Oxcarbazepine API needed in India [ENA23829]
    A non-profit organization that focuses on medicines, dietary supplements and foods is looking for suppliers of Oxcarbazepine API. The required quantity is 50 g - 200 g for development purposes. The suppliers must support this enquiry with CoA.
    22 Aug 2025

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    22 Aug 2025

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    Oxcarbazepine (1.75 MT) API needed in Russia [ENA19809]
    A company that focuses on manufacturing and development of various finished formulations is looking for suppliers of Oxcarbazepine (1.75 MT) API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    27 Jun 2024

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    27 Jun 2024

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    Oxcarbazepine (1 MT) API needed in India [ENA19611]
    A research-based company that focuses on diabetes, oncology, immunology, and other non-communicable diseases is looking for suppliers of Oxcarbazepine (1 MT) API for commercial purposes. The suppliers must support this enquiry with USDMF, GMP & CoA.
    30 May 2024

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    30 May 2024

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    USP Grade Oxcarbazepine (3 kg) API needed in India [ENA18029]
    A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of USP Grade Oxcarbazepine (3 kg) API for commercial purposes.
    14 Sep 2023

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    14 Sep 2023

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    Various APIs needed in India [ENA17568]
    A company that specializes in manufacturing liquid ampoules, liquid vials, dry injections, eye/ ear drops, tablets and syrups is looking for suppliers of Various APIs for both development and commercial purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA. 1. Silodosin API 2. Valsartan API 3. Paliperidone API 4. Oxcarbazepine API 5. Nitrofurantoin API 6. Ursodeoxycholic Acid API 7. Rosuvastatin API 8. Fenofibrate API 9. Aripiprazole API 10. Clonazepam API 11. Sacubitril API
    15 Jul 2023

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    15 Jul 2023

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    Various APIs needed in India [ENA13691]
    A company that deals in the development & manufacturing of finished formulations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. IP Grade Oxcarbamazepine API 2. IP Grade Citicoline Sodium API 3. Cinitapride Hydrogen Tartrate API 4. Clopidogrel Bisulphate API 5. IP Grade Chlordiazepoxide API
    20 May 2022

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    20 May 2022

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    Oxcarbazepine & Zinc Bisglycinate APIs needed in India [ENA13166]
    A pharmaceutical manufacturing company that deals in beta-lactam, non beta-lactam and food supplements for both tablets and capsules is looking for suppliers of Oxcarbazepine & Zinc Bisglycinate APIs for commercial purpose. The required quantity is 10 kg for each. The suppliers must support this enquiry with CoA.
    31 Mar 2022

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    31 Mar 2022

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    Various APIs needed in India [ENA12704]
    A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Ketoconazole (25 kg) API 2. Fexofenadine (25 kg) API 3. Mupirocin (1 kg) API 4. Naproxen (50 kg) API 5. IP Grade Domperidone (50 kg) API 6. Myoinositol (200 kg) API 7. L-Glutathione (10 kg) API 8. Oxcarbazepine (5 kg) API
    15 Feb 2022

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    15 Feb 2022

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    Various APIs needed in India [ENA12291]
    A company that deals in research, development & manufacturing of nephrology, CNS, gastroenterology, gynecology, urology, orthopedics, respiratory and cardio-metabolic formulations is looking for suppliers of Various APIs for commercial purpose. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA. 1. Thiamine API 2. Oxcarbazepine API 3. Esomeprazole Magnesium API
    03 Jan 2022

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    03 Jan 2022

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    EDQM

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    EDQM, Council of Europe

    Oxcarbazepine impurity mixture

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    EDQM, Council of Europe

    France
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    Oxcarbazepine impurity mixture

    CAS Number : n/a

    Quantity Per Vial : 0.008 mg

    Sale Unit : 1

    Order Code : Y0001549

    Batch No : 1

    Price (€) : 79

    Storage : +5°C ± 3°C

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    Oxcarbazepine

    CAS Number : 28721-07-5

    Quantity Per Vial : 120 mg

    Sale Unit : 1

    Order Code : Y0001576

    Batch No : 1

    Price (€) : 79

    Storage : +5°C ± 3°C

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    N-Carbamoyl Oxcarbazepine

    CAS Number : 2642430-30-4

    Quantity Per Vial :

    Price ($) : 1200

    Catalog Number : 1A08190

    Current Lot : 25 mg

    Previous Lot :

    NDC Code :

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    Methoxy Carbamazepine

    CAS Number : 28721-09-7

    Quantity Per Vial :

    Price ($) : 750

    Catalog Number : 1A07840

    Current Lot : 25 mg

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    Dibenzazepinodione

    CAS Number : 19579-83-0

    Quantity Per Vial :

    Price ($) : 1100

    Catalog Number : 1A03260

    Current Lot : 50 mg

    Previous Lot :

    NDC Code :

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    ANALYTICAL

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    ABOUT THIS PAGE

    Looking for 28721-07-5 / Oxcarbazepine API manufacturers, exporters & distributors?

    Oxcarbazepine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Oxcarbazepine

    Synonyms

    28721-07-5, Trileptal, Oxcarbamazepine, Oxcarbazepina, Oxcarbazepinum, Gp 47680

    Cas Number

    28721-07-5

    Unique Ingredient Identifier (UNII)

    VZI5B1W380

    About Oxcarbazepine

    A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.

    Oxetol Manufacturers

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

    Oxetol Suppliers

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

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

    Oxetol USDMF

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

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

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

    Oxetol KDMF

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

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

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

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

    Oxetol CEP

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

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

    Oxetol WC

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

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

    Oxetol 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 Oxetol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Oxetol GMP

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

    Oxetol CoA

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

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

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