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Temozolamide

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43 API Suppliers, 16 USDMF, 8 CEP/COS, 3 JDMF, 8 EU WC, 7 KDMF, 13 NDC API, 31 Listed Suppliers, $ API Reference Price

43 API Suppliers
16 USDMF
8 CEP/COS
3 JDMF
8 EU WC
7 KDMF
13 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

69 Drugs in Development

69 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

480 FDF Dossiers, 102 FDA Orange Book, 227 Europe, 25 Canada, 35 Australia, 18 South Africa, 73 Listed Dossiers

480 FDF Dossiers
102 FDA Orange Book
227 Europe
25 Canada
35 Australia
18 South Africa
73 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 140MG, CAPSULE;ORAL - 180MG, CAPSULE;ORAL - 20MG, CAPSULE;ORAL - 250MG, CAPSULE;ORAL - 5MG

drugProductComposition
CAPSULE;ORAL - 100MG
CAPSULE;ORAL - 140MG
CAPSULE;ORAL - 180MG
CAPSULE;ORAL - 20MG
CAPSULE;ORAL - 250MG
CAPSULE;ORAL - 5MG

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 167 Finished Drug Prices, 5 Annual Reports

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1 US Medicaid Prescriptions
167 Finished Drug Prices
5 Annual Reports

MARKET PLACE

8 APIs, 12 FDF Dossiers

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8 APIs
12 FDF Dossiers

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12 Health Canada Patents

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4 USP , 9 Others

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4 USP
9 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 6,755

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

480

FDF Dossiers

102

FDA Orange Book

227

Europe

Canada

Australia

South Africa

Listed Dossiers

69DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

117,038

Annual Reports (USD Million)

1,067

Finished Drug Prices

175 RELATED EXCIPIENT COMPANIES

295EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₆H₆N₆O₂
Molecular Weight	194.15 g/mol
XLogP3	-1.1
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	1
Exact Mass	194.05522346 g/mol
Monoisotopic Mass	194.05522346 g/mol
Topological Polar Surface Area	106 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	315
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Temodar
PubMed Health	Temozolomide (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	TEMODAR 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 Ingredient	Temozolomide
Dosage Form	Capsule; Powder
Route	Oral; Intravenous
Strength	180mg; 250mg; 140mg; 5mg; 100mg/vial; 100mg; 20mg
Market Status	Prescription
Company	Merck Sharp Dohme

2 of 4
Drug Name	Temozolomide
PubMed Health	Temozolomide
Drug Classes	Antineoplastic Agent
Drug Label	TEMODAR 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 Ingredient	Temozolomide
Dosage Form	Capsule
Route	Oral
Strength	180mg; 250mg; 140mg; 5mg; 100mg; 20mg
Market Status	Prescription
Company	Sun Pharma Global; Barr

3 of 4
Drug Name	Temodar
PubMed Health	Temozolomide (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	TEMODAR 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 Ingredient	Temozolomide
Dosage Form	Capsule; Powder
Route	Oral; Intravenous
Strength	180mg; 250mg; 140mg; 5mg; 100mg/vial; 100mg; 20mg
Market Status	Prescription
Company	Merck Sharp Dohme

4 of 4
Drug Name	Temozolomide
PubMed Health	Temozolomide
Drug Classes	Antineoplastic Agent
Drug Label	TEMODAR 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 Ingredient	Temozolomide
Dosage Form	Capsule
Route	Oral
Strength	180mg; 250mg; 140mg; 5mg; 100mg; 20mg
Market Status	Prescription
Company	Sun 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.

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;

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

Temozolomide Sun is indicated for the treatment of:

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

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

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

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 T_max of one hour. Following a single oral dose of 150 mg/m², temozolomide and its active MTIC metabolite had C_max 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 C_max 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 C_max and AUC to decrease by 32% and 9%, respectively, and the median T_max 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 T_reg 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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Temozolomide (non-sterile Bulk Drug Substance)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23547

Submission : 2010-02-17

Status : Active

Type : II

02

Wavelength Enterprises Ltd

France

Antibody Engineering

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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Digital Content

Temozolomide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19347

Submission : 2006-04-10

Status : Active

Type : II

03

Beijing Lunarsun Pharmaceutical Co L...

China

Antibody Engineering

Not Confirmed

Antibody Engineering

Not Confirmed

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API Reference Price

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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,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724869800,"product":"TEMOZOLOMIDE (FINE) 3-METHYL-4-OXOIMIDAZO 5,1- D1,2,3,5TETRAZINE-8- CARBOXAMIDE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAOYUAN","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"4500","totalValueFC":"113802.9","currency":"USD","unitRateINR":"381825","date":"29-Aug-2024","totalValueINR":"9545625","totalValueInUsd":"113802.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"5301157","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAOYUAN","supplierAddress":"36 Hoping Street, Louchu Taoyuan 33842, Taiwan SDNF Taiwan","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

Taro Pharmaceutical Industries

U.S.A

Medlab Asia & Asia Health

Not Confirmed

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Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

TEMOZOLOMIDE

Brand Name : TARO-TEMOZOLOMIDE

Dosage Form : CAPSULE

Dosage Strength : 5MG

Packaging : May-20

Approval Date :

Application Number : 2443473

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

Taro Pharmaceutical Industries

U.S.A

Medlab Asia & Asia Health

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

TEMOZOLOMIDE

Brand Name : TARO-TEMOZOLOMIDE

Dosage Form : CAPSULE

Dosage Strength : 20MG

Packaging : May-20

Approval Date :

Application Number : 2443481

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

Taro Pharmaceutical Industries

U.S.A

Medlab Asia & Asia Health

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

TEMOZOLOMIDE

Brand Name : TARO-TEMOZOLOMIDE

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging : May-20

Approval Date :

Application Number : 2443511

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

04

Taro Pharmaceutical Industries

U.S.A

Medlab Asia & Asia Health

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

TEMOZOLOMIDE

Brand Name : TARO-TEMOZOLOMIDE

Dosage Form : CAPSULE

Dosage Strength : 140MG

Packaging : May-20

Approval Date :

Application Number : 2443538

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

Taro Pharmaceutical Industries

U.S.A

Medlab Asia & Asia Health

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

TEMOZOLOMIDE

Brand Name : TARO-TEMOZOLOMIDE

Dosage Form : CAPSULE

Dosage Strength : 250MG

Packaging : May-20

Approval Date :

Application Number : 2443554

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

Alfred E Tiefenbacher GmbH

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Alfred E Tiefenbacher GmbH

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 140MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Alfred E Tiefenbacher GmbH

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Alfred E Tiefenbacher GmbH

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Alfred E Tiefenbacher GmbH

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

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Digital Content

Website

Corporate PDF

Only 10 entries up to this point, click to access all

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FDA Orange Book

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Europe

01

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

04

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 140MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 180MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Temozolomide

Brand Name :

Dosage Form : Capsule

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Accord Healthcare AG

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

08

Sun Pharmaceutical Industries

India

Medlab Asia & Asia Health

Not Confirmed

09

SUN PHARMACEUTICAL IND.EU.B.V.

India

Medlab Asia & Asia Health

Not Confirmed

10

TEVA B.V.

Israel

Medlab Asia & Asia Health

Not Confirmed

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 21029

DOSAGE - CAPSULE;ORAL - 140MG

USFDA APPLICATION NUMBER - 21029

DOSAGE - CAPSULE;ORAL - 180MG

USFDA APPLICATION NUMBER - 21029

DOSAGE - CAPSULE;ORAL - 20MG

USFDA APPLICATION NUMBER - 21029

DOSAGE - CAPSULE;ORAL - 250MG

USFDA APPLICATION NUMBER - 21029

DOSAGE - CAPSULE;ORAL - 5MG

USFDA APPLICATION NUMBER - 21029

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Solubilizers

Direct Compression

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Lubricants & Glidants

Granulation

Topical

Parenteral

Coating Systems & Additives

Co-Processed Excipients

Taste Masking

Controlled & Modified Release

Film Formers & Plasticizers

Chewable & Orodispersible Aids

Empty Capsules

Emulsifying Agents

API Stability Enhancers

Coloring Agents

Surfactant & Foaming Agents

Rheology Modifiers

Digital Content

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DATA COMPILATION #PharmaFlow

NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

01

Brand Name : Temodal

U.S.A

United Kingdom

Antibody Engineering

Not Confirmed

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Annual Reports

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Market Place

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APIs

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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Health Canada Patents

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REF. STANDARDS & IMPURITIES

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USP

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ACCESS ALL DATA

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers

16 USDMF

8 CEP/COS

3 JDMF

8 EU WC

7 KDMF

13 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

69 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

480 FDF Dossiers

102 FDA Orange Book

227 Europe

25 Canada

35 Australia

18 South Africa

73 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG

CAPSULE;ORAL - 140MG

CAPSULE;ORAL - 180MG

CAPSULE;ORAL - 20MG

CAPSULE;ORAL - 250MG

CAPSULE;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

1 Evonik

1 Rochem International Inc

13 SPI Pharma

2 Seqens

8 DKSH

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Capital Farma

4 ACG Worldwide

8 Actylis

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

27 BASF

3 DFE Pharma

2 Finar

10 Gangwal Chemicals

3 Ingredion Pharma Solutions

9 Kerry

3 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qualicaps

10 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

4 Sigachi Industries

1 Ulanqab Kema New Material

1 Valens Pharmachem

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders

25 Solubilizers

23 Direct Compression

22 Disintegrants & Superdisintegrants

18 Thickeners and Stabilizers

17 Lubricants & Glidants