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    Chemistry

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    Also known as: 85622-93-1, Methazolastone, Temodar, Temodal, Temozolamide, 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide
    Molecular Formula
    C6H6N6O2
    Molecular Weight
    194.15  g/mol
    InChI Key
    BPEGJWRSRHCHSN-UHFFFAOYSA-N
    FDA UNII
    YF1K15M17Y
    Temozolomide
    A dacarbazine derivative that is used as an alkylating antineoplastic agent for the treatment of MALIGNANT GLIOMA and MALIGNANT MELANOMA.
    Temozolomide is an Alkylating Drug. The mechanism of action of temozolomide is as an Alkylating Activity.
    1 2D Structure

    Temozolomide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide
    2.1.2 InChI
    InChI=1S/C6H6N6O2/c1-11-6(14)12-2-8-3(4(7)13)5(12)9-10-11/h2H,1H3,(H2,7,13)
    2.1.3 InChI Key
    BPEGJWRSRHCHSN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1C(=O)N2C=NC(=C2N=N1)C(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    YF1K15M17Y
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3h)-one

    2. Ccrg 81045

    3. Ccrg-81045

    4. Ccrg81045

    5. M And B 39831

    6. M And B-39831

    7. M And B39831

    8. Methazolastone

    9. Nsc 362856

    10. Nsc-362856

    11. Nsc362856

    12. Temodal

    13. Temodar

    14. Temozolomide Hexyl Ester

    15. Tmz Bioshuttle

    16. Tmz-bioshuttle

    17. Tmza-he

    2.3.2 Depositor-Supplied Synonyms

    1. 85622-93-1

    2. Methazolastone

    3. Temodar

    4. Temodal

    5. Temozolamide

    6. 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    7. Sch 52365

    8. Ccrg-81045

    9. Temozolomidum [latin]

    10. Temozolodida [spanish]

    11. Temozolomidum

    12. Ccrg 81045

    13. Nsc 362856

    14. Sch-52365

    15. M&b 39831

    16. M&b-39831

    17. Nsc-362856

    18. Ccris 8996

    19. Mb 39831

    20. 8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3h)-one

    21. M & B 39831

    22. Brn 5547136

    23. M-39831

    24. 3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide

    25. 3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide

    26. 3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide

    27. Nsc362856

    28. 3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    29. Chembl810

    30. Mls002701861

    31. Yf1k15m17y

    32. Chebi:72564

    33. Mk-7365

    34. Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

    35. Tmz

    36. Ncgc00167429-01

    37. Temozolodida

    38. 3-methyl-4-oxo-3h,4h-imidazo[4,3-d][1,2,3,5]tetrazine-8-carboxamide

    39. 8-carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3h)-one

    40. Dsstox_cid_23714

    41. Dsstox_rid_80068

    42. Dsstox_gsid_43714

    43. 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide

    44. 3-methyl-4-oxo-3,4-dihydroimidazo-[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    45. 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide.

    46. 3-methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic Acid Amide

    47. Smr000466338

    48. Temodal (tn)

    49. Temodar (tn)

    50. Cas-85622-93-1

    51. Temozolomide, Vetranal(tm), Analytical Standard

    52. Sr-01000759347

    53. Temozolomida

    54. Unii-yf1k15m17y

    55. Temozolomide (jan/usan/inn)

    56. Temozolomide [usan:inn:ban]

    57. Imidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

    58. Mfcd00866492

    59. Temozolomide- Bio-x

    60. Temozolomide [mi]

    61. Temozolomide [inn]

    62. Temozolomide [jan]

    63. Temodar (tn) (schering)

    64. Temozolomide [usan]

    65. Schembl3739

    66. 4-methyl-5-oxo-2,3,4,6,8-pentazabicyclo[4.3.0]nona-2,7,9-triene-9-carboxamide

    67. Temozolomide [vandf]

    68. Temozolomide [mart.]

    69. Mls000759447

    70. Mls001424028

    71. Bidd:gt0204

    72. Temozolomide [usp-rs]

    73. Temozolomide [who-dd]

    74. Gtpl7301

    75. Temozolomide [ema Epar]

    76. Dtxsid5043714

    77. Temozolomide, >=98% (hplc)

    78. Hms2051o12

    79. Hms2090b08

    80. Hms2232n13

    81. Hms3264i14

    82. Hms3269p05

    83. Hms3372k13

    84. Hms3393o12

    85. Hms3413d06

    86. Hms3654n05

    87. Hms3677d06

    88. Hms3713h16

    89. Pharmakon1600-01502289

    90. Temozolomide [orange Book]

    91. Temozolomide [ep Monograph]

    92. 3-methyl-4-oxo-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    93. Albb-021358

    94. Bcp03692

    95. Zinc1482184

    96. Temozolomide [usp Monograph]

    97. Tox21_112433

    98. Ac-758

    99. Bdbm50034562

    100. Dl-190

    101. Nsc759883

    102. S1237

    103. Stk623541

    104. 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    105. 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetraazine-8-carboxamide

    106. Akos005557098

    107. Tox21_112433_1

    108. Ccg-100870

    109. Cs-0943

    110. Db00853

    111. Ks-1216

    112. Nc00120

    113. Nsc-759883

    114. Imidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

    115. Ncgc00167429-02

    116. Ncgc00167429-04

    117. Ncgc00167429-05

    118. Bp-25388

    119. Bt164447

    120. Hy-17364

    121. Nci60_003316

    122. Bcp0726000154

    123. Temozolomide 100 Microg/ml In Acetonitrile

    124. Am20110227

    125. Ft-0630936

    126. Ft-0674845

    127. Sw197500-4

    128. T2744

    129. D06067

    130. Ab00639915-06

    131. Ab00639915-08

    132. Ab00639915-09

    133. Ab00639915_10

    134. Ab00639915_11

    135. 622t931

    136. A841386

    137. Q425088

    138. Q-201786

    139. Sr-01000759347-4

    140. Sr-01000759347-5

    141. Brd-k32107296-001-04-5

    142. Z1551429743

    143. 3-methyl-4-oxo-8-imidazo[5,1-d][1,2,3,5]tetrazinecarboxamide

    144. Temozolomide, United States Pharmacopeia (usp) Reference Standard

    145. 3-methyl-4-oxidanylidene-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

    146. 3-methyl-8-aminocarbonyl-imidazo[5,1-d]-1,2,3,5-tetrazin-4(3h)-one

    147. Imidazo[5,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

    148. {imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide,} 3, 4-dihydro-3-methyl-4-oxo-

    149. Temozolomide, Pharmaceutical Secondary Standard; Certified Reference Material

    150. 3-methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic Acid Amide (temozolomide)

    151. 3-methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic Acid Amide(temozolomide)

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 194.15 g/mol
    Molecular Formula C6H6N6O2
    XLogP3-1.1
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count1
    Exact Mass194.05522346 g/mol
    Monoisotopic Mass194.05522346 g/mol
    Topological Polar Surface Area106 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity315
    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 NameTemodar
    PubMed HealthTemozolomide (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelTEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:The material is a white to light tan/light pink powder...
    Active IngredientTemozolomide
    Dosage FormCapsule; Powder
    RouteOral; Intravenous
    Strength180mg; 250mg; 140mg; 5mg; 100mg/vial; 100mg; 20mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 4  
    Drug NameTemozolomide
    PubMed HealthTemozolomide
    Drug ClassesAntineoplastic Agent
    Drug LabelTEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:The material is a white to light tan/light pink powder...
    Active IngredientTemozolomide
    Dosage FormCapsule
    RouteOral
    Strength180mg; 250mg; 140mg; 5mg; 100mg; 20mg
    Market StatusPrescription
    CompanySun Pharma Global; Barr

    3 of 4  
    Drug NameTemodar
    PubMed HealthTemozolomide (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelTEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:The material is a white to light tan/light pink powder...
    Active IngredientTemozolomide
    Dosage FormCapsule; Powder
    RouteOral; Intravenous
    Strength180mg; 250mg; 140mg; 5mg; 100mg/vial; 100mg; 20mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 4  
    Drug NameTemozolomide
    PubMed HealthTemozolomide
    Drug ClassesAntineoplastic Agent
    Drug LabelTEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:The material is a white to light tan/light pink powder...
    Active IngredientTemozolomide
    Dosage FormCapsule
    RouteOral
    Strength180mg; 250mg; 140mg; 5mg; 100mg; 20mg
    Market StatusPrescription
    CompanySun Pharma Global; Barr

    4.2 Drug Indication

    Temozolomide is indicated in adult patients for the treatment of newly diagnosed glioblastoma concomitantly with radiotherapy and for use as maintenance treatment thereafter. It is also indicated for the treatment of refractory anaplastic astrocytoma in adult patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

    FDA Label

    For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

    For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

    For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    Temodal hard capsules is indicated for the treatment of:

    - adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment;

    - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    Temomedac hard capsules is indicated for the treatment of:

    - adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;

    - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

    For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    Temozolomide Sun is indicated for the treatment of:

    - adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;

    - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

    For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

    Treatment of malignant glioma

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Temozolomide is a prodrug of the imidazotetrazine class that requires nonenzymatic hydrolysis at physiological pH _in vivo_ to perform alkylation of adenine/guanine residues, leading to DNA damage through futile repair cycles and eventual cell death. Temozolomide treatment is associated with myelosuppression, which is likely to be more severe in females and geriatric patients. Patients must have an ANC of 1.5 x 109/L and a platelet count of 100 x 109/L before starting therapy and must be monitored weekly during the concomitant radiotherapy phase, on days one and 22 of maintenance cycles, and weekly at any point where the ANC/platelet count falls below the specified values until recovery. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed following temozolomide administration. Pneumocystis pneumonia may occur in patients undergoing treatment, and prophylaxis should be provided for patients in the concomitant phase of therapy with monitoring at all stages. Severe hepatotoxicity has also been reported, and liver testing should be performed at baseline, midway through the first cycle, before each subsequent cycle, and approximately two to four weeks after the last dose. Animal studies suggest that temozolomide has significant embryo-fetal toxicity; male and female patients should practice contraception up to three and six months following the last dose of temozolomide, respectively.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents, Alkylating

    A class of drugs that differs from other alkylating agents used clinically in that they are monofunctional and thus unable to cross-link cellular macromolecules. Among their common properties are a requirement for metabolic activation to intermediates with antitumor efficacy and the presence in their chemical structures of N-methyl groups, that after metabolism, can covalently modify cellular DNA. The precise mechanisms by which each of these drugs acts to kill tumor cells are not completely understood. (From AMA, Drug Evaluations Annual, 1994, p2026) (See all compounds classified as Antineoplastic Agents, Alkylating.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TEMOZOLOMIDE
    5.3.2 FDA UNII
    YF1K15M17Y
    5.3.3 Pharmacological Classes
    Alkylating Drug [EPC]; Alkylating Activity [MoA]
    5.4 ATC Code

    L01AX03

    L01AX03

    L01AX03

    L01AX03

    L01AX03

    L01AX03

    L01AX03

    L01AX03

    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

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01A - Alkylating agents

    L01AX - Other alkylating agents

    L01AX03 - Temozolomide

    5.5 Absorption, Distribution and Excretion

    Absorption

    Temozolomide is rapidly and completely absorbed in the gastrointestinal tract and is stable at both acidic and neutral pH. Therefore, temozolomide may be administered both orally and intravenously with a median Tmax of one hour. Following a single oral dose of 150 mg/m2, temozolomide and its active MTIC metabolite had Cmax values of 7.5 g/mL and 7.5 g/mL and AUC values of 23.4 g\*hr/mL and 864 ng\*hr/mL, respectively. Similarly, following a single 90-minute IV infusion of 150 mg/m2, temozolide and its active MTIC metabolite had Cmax values of 7.3 g/mL and 276 ng/mL and AUC values of 24.6 g\*hr/mL and 891 ng\*hr/mL, respectively. Temozolomide kinetics are linear over the range of 75-250 mg/m2/day. Oral temozolomide absorption is affected by food. Administration following a high-fat breakfast of 587 calories caused the mean Cmax and AUC to decrease by 32% and 9%, respectively, and the median Tmax to increase by 2-fold (from 1-2.25 hours).

    Route of Elimination

    Roughly 38% of administered temozolomide can be recovered over seven days, with 38% in the urine and only 0.8% in the feces. The recovered material comprises mainly metabolites: unidentified polar metabolites (17%), AIC (12%), and the temozolomide acid metabolite (2.3%). Only 6% of the recovered dose represents unchanged temozolomide.

    Volume of Distribution

    Temozolomide has a mean apparent volume of distribution (%CV) of 0.4 (13%) L/kg.

    Clearance

    Temozolomide has a clearance of approximately 5.5 L/hr/m2.

    5.6 Metabolism/Metabolites

    After absorption, temozolomide undergoes nonenzymatic chemical conversion to the active metabolite 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) plus carbon dioxide and to a temozolomide acid metabolite, which occurs at physiological pH but is enhanced with increasing alkalinity. MTIC subsequently reacts with water to produce 5-aminoimidazole-4-carboxamide (AIC) and a highly reactive methyl diazonium cation, the active alkylating species. The cytochrome P450 system plays only a minor role in temozolomide metabolism. Relative to the AUC of temozolomide, the exposure to MTIC and AIC is 2.4% and 23%, respectively.

    5.7 Biological Half-Life

    Temozolomide has a mean elimination half-life of 1.8 hours.

    5.8 Mechanism of Action

    Glioblastoma (glioblastoma multiforme) is the most common and aggressive adult primary brain tumour, accounting for 45.6% of all primary malignant brain tumours. Primarily defined histopathologically by necrosis and microvascular proliferation (WHO grade IV classification), glioblastomas are commonly treated through radiotherapy and concomitant alkylation-based chemotherapy with temozolomide. Temozolomide (TMZ) is a small (194 Da) lipophilic alkylating agent of the imidazotetrazine class that is stable at acidic pH, allowing for both oral and intravenous dosing, and can cross the blood-brain barrier to affect CNS tumours. After absorption, TMZ undergoes spontaneous nonenzymatic breakdown at physiological pH to form 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC), which then reacts with water to produce 5-aminoimidazole-4-carboxamide (AIC) and a highly reactive methyl diazonium cation. Brain tumours such as glioblastoma typically possess a more alkaline pH than healthy tissue, favouring TMZ activation within tumour tissue. The methyl diazonium cation is highly reactive and methylates DNA at the N7 position of guanine (N7-MeG, 70%), the N3 position of adenine (N3-MeA, 9%), and the O6 position of guanine (O6-MeG, 6%). Although more prevalent, N7-MeG and N3-MeA are rapidly repaired by the base excision repair pathway and are not primary mediators of temozolomide toxicity, although N3-MeA lesions are lethal if not repaired. By comparison, repair of O6-MeG requires action by the suicide enzyme methylguanine-DNA methyltransferase (MGMT), which removes the methyl group to restore guanine. If not repaired by MGMT, O6-MeG mispairs with thymine, activating the DNA mismatch repair (MMR) pathway that removes the thymine (not the O6-MeG), resulting in futile cycles of repair and eventual DNA strand breaks leading to apoptosis. As MMR activity is crucial for temozolomide cytotoxicity, cells that have reduced or absent MGMT function and an intact MMR pathway are the most sensitive to temozolomide treatment. Glioblastomas that upregulate MGMT downregulate MMR or alter both are resistant to TMZ, leading to treatment failure. More recently, increased interest has also been shown in the immunomodulatory effects of TMZ, related to its myelosuppressive effects. Counterintuitively, lymphodepletion may enhance the antitumour effects of cellular immunotherapy and improve the dynamics of memory cells by altering tumour-specific versus tumour-tolerant populations. The depletion of tumour-localized immunosuppressive Treg cells may contribute to an improved response to immunotherapy. Hence, TMZ treatment may also form the backbone of immunotherapy strategies against glioblastoma in the future.

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1639765800,"product":"TEMOZOLOMIDE USP","address":"SY.NO. 342, PLOT NOS. 118,119 & 120 ALEAP INDL. ESTATE, ROAD NO. 6","city":"PRAGATHI NAGAR, HYDERABAD,TELANGANA","supplier":"SAINTSUN PHARMA","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"THERDOSE PHARMA","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"2000","totalValueFC":"5114.3","currency":"USD","unitRateINR":"154300","date":"18-Dec-2021","totalValueINR":"385750","totalValueInUsd":"5114.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"6732785","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"","customerAddress":"SY.NO. 342, PLOT NOS. 118,119 & 120 ALEAP INDL. ESTATE, ROAD NO. 6"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654021800,"product":"TEMOZOLOMIDE","address":"Ashvich Towers 3rd Floor, No 3, Developed Plots In","city":"Chennai","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"11","totalValueFC":"554.1","currency":"USD","unitRateINR":"864.6","date":"01-Jun-2022","totalValueINR":"43230","totalValueInUsd":"554.1","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"8920774","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Ashvich Towers 3rd Floor, No 3, Developed Plots In"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659897000,"product":"TEMOZOLOMIDE","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"6.13","actualQuantity":"6.13","unit":"KGS","unitRateFc":"4700","totalValueFC":"29058.3","currency":"USD","unitRateINR":"377175","date":"08-Aug-2022","totalValueINR":"2312082.75","totalValueInUsd":"29058.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9914495","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659897000,"product":"TEMOZOLOMIDE","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"23.46","actualQuantity":"23.46","unit":"KGS","unitRateFc":"4700","totalValueFC":"111208.3","currency":"USD","unitRateINR":"377175","date":"08-Aug-2022","totalValueINR":"8848525.5","totalValueInUsd":"111208.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9914495","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662316200,"product":"CHEMICAL : TEMOZOLOMIDE(FINE)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAOYUAN","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"58.00","actualQuantity":"58","unit":"KGS","unitRateFc":"5506.6","totalValueFC":"320616.3","currency":"USD","unitRateINR":"443009","date":"05-Sep-2022","totalValueINR":"25694523","totalValueInUsd":"320616.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1003624","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAOYUAN","supplierAddress":"36 HOPING STREET, LOUCHU COUNTY TAOYUAN TAIWAN-33842","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676917800,"product":"TEMOZOLOMIDE RELATED COMPOUND B (QTY:3 X 15 MG, PRICE USD:838\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.000045","unit":"KGS","unitRateFc":"55866666.7","totalValueFC":"2699","currency":"USD","unitRateINR":"4953561778","date":"21-Feb-2023","totalValueINR":"222910.28","totalValueInUsd":"2699","indian_port":"HYDERABAD AIR","hs_no":"29242190","bill_no":"4742118","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676917800,"product":"TEMOZOLOMIDE(QTY:1 X 200 MG, PRICE USD:622)(FOC)","address":"P.NO. 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LTD","customerCountry":"INDIA","quantity":"1.35","actualQuantity":"1.35","unit":"KGS","unitRateFc":"5200","totalValueFC":"7084.9","currency":"USD","unitRateINR":"431339.9","date":"31-Jul-2023","totalValueINR":"582308.65","totalValueInUsd":"7084.9","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690741800,"product":"TEMOZOLOMIDE","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"FORMOSA LABORATOREIS INC","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"5200","totalValueFC":"20992.5","currency":"USD","unitRateINR":"431339.9","date":"31-Jul-2023","totalValueINR":"1725360.413","totalValueInUsd":"20992.5","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697049000,"product":"TEMOZOLOMIDE USP","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"6.61","actualQuantity":"6.61","unit":"KGS","unitRateFc":"4800","totalValueFC":"32513.5","currency":"USD","unitRateINR":"409390.9","date":"12-Oct-2023","totalValueINR":"2706074.13","totalValueInUsd":"32513.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8255204","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"36 HOPING STREET, LOUCHU TAOYUAN 33842, TAIWANSDNF Taiwan, Province of China","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697049000,"product":"TEMOZOLOMIDE USP","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"20.99","actualQuantity":"20.99","unit":"KGS","unitRateFc":"4800","totalValueFC":"103246.3","currency":"USD","unitRateINR":"409390.9","date":"12-Oct-2023","totalValueINR":"8593115.89","totalValueInUsd":"103246.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8255204","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"36 HOPING STREET, LOUCHU TAOYUAN 33842, TAIWANSDNF Taiwan, Province of China","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698604200,"product":"TEMOZOLOMIDE","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"JODAS EXPOIM PVT. 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M.N. DESAI PETROL PUMP","city":"AHMEDABAD, GUJARAT","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"SAKAR HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"1.08","actualQuantity":"1.08","unit":"KGS","unitRateFc":"5300","totalValueFC":"5790.3","currency":"USD","unitRateINR":"449705","date":"21-Aug-2024","totalValueINR":"485681.4","totalValueInUsd":"5790.3","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"5160826","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 33842, TAIWAN.SDNF TAIWAN","customerAddress":"10\/13, NR. M.N. DESAI PETROL PUMP"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"TEMOZOLOMIDE","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"1.02","actualQuantity":"1.02","unit":"KGS","unitRateFc":"5500","totalValueFC":"5675","currency":"USD","unitRateINR":"466675","date":"26-Aug-2024","totalValueINR":"476008.5","totalValueInUsd":"5675","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5249085","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"36 HOPING STREET LOUCHU TAOYUAN 33842SDNF Taiwan","customerAddress":"101, SITARAM MANSION,"}]
    13-Jan-2021
    27-Nov-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - 100MG

    USFDA APPLICATION NUMBER - 21029

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    DOSAGE - CAPSULE;ORAL - 140MG

    USFDA APPLICATION NUMBER - 21029

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    DOSAGE - CAPSULE;ORAL - 180MG

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    DOSAGE - CAPSULE;ORAL - 20MG

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    DOSAGE - CAPSULE;ORAL - 250MG

    USFDA APPLICATION NUMBER - 21029

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    DOSAGE - CAPSULE;ORAL - 5MG

    USFDA APPLICATION NUMBER - 21029

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    ABOUT THIS PAGE

    Temozolomide Manufacturers

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

    Temozolomide Suppliers

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

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

    Temozolomide USDMF

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

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

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

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

    Temozolomide KDMF

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

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

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

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

    Temozolomide CEP

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

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

    Temozolomide WC

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

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

    Temozolomide 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 Temozolomide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Temozolomide GMP

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

    Temozolomide CoA

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

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

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