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38 API Suppliers, 21 USDMF, 6 CEP/COS, 6 EU WC, 17 NDC API, 19 Listed Suppliers, $ API Reference Price

38 API Suppliers
21 USDMF
6 CEP/COS
6 EU WC
17 NDC API
19 Listed Suppliers
$ API Reference Price

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79 FDA Orange Book
15 Europe
8 Canada
9 Australia
6 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML), SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML), SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)

drugProductComposition
INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 25MG
CAPSULE;ORAL - 50MG
SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML)
SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML)
SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)

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Synopsis

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Chemistry

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Also known as: 50-18-0, Cyclophosphamid, Cyclophosphane, Cytoxan, Cytophosphan, Procytox

Molecular Formula

C₇H₁₅Cl₂N₂O₂P

Molecular Weight

261.08 g/mol

InChI Key

CMSMOCZEIVJLDB-UHFFFAOYSA-N

FDA UNII

6UXW23996M

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Cyclophosphamide anhydrous is an Alkylating Drug. The mechanism of action of cyclophosphamide anhydrous is as an Alkylating Activity.

1 2D Structure

Cyclophosphamide

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N,N-bis(2-chloroethyl)-2-oxo-1,3,25-oxazaphosphinan-2-amine

2.1.2 InChI

InChI=1S/C7H15Cl2N2O2P/c8-2-5-11(6-3-9)14(12)10-4-1-7-13-14/h1-7H2,(H,10,12)

2.1.3 InChI Key

CMSMOCZEIVJLDB-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CNP(=O)(OC1)N(CCCl)CCCl

2.2 Other Identifiers

2.2.1 UNII

6UXW23996M

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (+,-)-2-(bis(2-chloroethyl)amino)tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide Monohydrate

2. B 518

3. B-518

4. B518

5. Cyclophosphamide Anhydrous

6. Cyclophosphamide Monohydrate

7. Cyclophosphamide, (r)-isomer

8. Cyclophosphamide, (s)-isomer

9. Cyclophosphane

10. Cytophosphan

11. Cytophosphane

12. Cytoxan

13. Endoxan

14. Neosar

15. Nsc 26271

16. Nsc-26271

17. Nsc26271

18. Procytox

19. Sendoxan

2.3.2 Depositor-Supplied Synonyms

1. 50-18-0

2. Cyclophosphamid

3. Cyclophosphane

4. Cytoxan

5. Cytophosphan

6. Procytox

7. Clafen

8. Endoxan

9. Cyclophosphan

10. Cyclostin

11. Neosar

12. Sendoxan

13. Cyclophosphamidum

14. Cytophosphane

15. Claphene

16. Endoxana

17. Endoxanal

18. Genoxal

19. Endoxan-asta

20. Endoxan R

21. Zyklophosphamid

22. Mitoxan

23. (rs)-cyclophosphamide

24. Cyclophosphoramide

25. Cyklofosfamid

26. Endoxane

27. Enduxan

28. Semdoxan

29. Senduxan

30. (+-)-cyclophosphamide

31. Cyclophosphamide Anhydrous

32. Cyclophosphanum

33. Rcra Waste Number U058

34. Asta B 518

35. 2h-1,3,2-oxazaphosphorin-2-amine, N,n-bis(2-chloroethyl)tetrahydro-, 2-oxide

36. Nsc 26271

37. Nsc-26271

38. Bis(2-chloroethyl)phosphoramide Cyclic Propanolamide Ester

39. B 518

40. Cb 4564

41. Nci-c04900

42. Sk 20501

43. Cyclofosphamide

44. Chebi:4027

45. N,n-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide

46. (-)-cyclophosphamide

47. Cyclophosphamide (inn)

48. N,n-bis(2-chloroethyl)tetrahydro-2h-1,3,2-oxazaphosphorin-2-amine 2-oxide

49. Nsc26271

50. Anhydrous Cyclophosphamide

51. Cytoxan (tn)

52. 50-18-0 (anhydrous)

53. 2-[bis(2-chloroethylamino)]-tetrahydro-2h-1,3,2-oxazaphosphorine-2-oxide

54. Ciclophosphamide

55. 2-(bis(2-chloroethyl)amino)-2h-1,3,2-oxazaphosphorine 2-oxide

56. Asta

57. 6uxw23996m

58. N,n-bis(2-chloroethyl)-n',o-propylenephosphoric Acid Ester Diamide

59. N,n-di(2-chloroethyl)-n,o-propylene-phosphoric Acid Ester Diamide

60. 2h-1,3,2-oxazaphosphorin-2-amine, N,n-bis(2-chloroethyl)tetrahydro-,2-oxide

61. Phosphorodiamidic Acid, N,n-bis(2-chloroethyl)-n'-(3-hydroxypropyl)-, Intramol. Ester

62. Lyophilized Cytoxan

63. Cy

64. Ciclofosfamida

65. D,l-cyclophosphamide

66. Cyklofosfamid [czech]

67. N,n-bis(2-chloroethyl)-2-oxo-1,3,2$l^{5}-oxazaphosphinan-2-amine

68. Ciclophosphamide [inn]

69. 2-[bis(2-chloroethyl)amino]tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide

70. Zyklophosphamid [german]

71. Cyclophosphamide [inn]

72. Cyclophosphamide (anhydrous)

73. Asta B518

74. Ciclofosfamida [inn-spanish]

75. Cyclophosphamidum [inn-latin]

76. Occupation, Cyclophosphamide Exposure

77. Ccris 188

78. 4-hydroxy-cyclophosphan-mamophosphatide

79. Cyclophosphamide (anhydrous Form)

80. Cyclophosphamide (tn)

81. Hsdb 3047

82. Sr-01000075737

83. Ncgc00015209-05

84. Einecs 200-015-4

85. Rcra Waste No. U058

86. Brn 0011744

87. Cyclophosphamide [usp:inn]

88. 2-(bis(2-chloroethyl)amino)-2h-1,2-oxazaphosphorine 2-oxide

89. 2-[bis(2-chloroethyl)amino]-2h-1,2-oxazaphosphorine 2-oxide

90. Unii-6uxw23996m

91. 1-bis(2-chloroethyl)amino-1-oxo-2-aza-5-oxaphosphoridin

92. Ai3-26198

93. (bis(chloro-2-ethyl)amino)-2-tetrahydro-3,5,6-oxazaphosphorine-1,3,2-oxide-2 Hydrate

94. [bis(chloro-2-ethyl)amino]-2-tetrahydro-3,5,6-oxazaphosphorine-1,3,2-oxide-2 Hydrate

95. 173547-45-0

96. Cb-4564

97. Cyclophosphamide-[d4]

98. Spectrum_000858

99. Chembl88

100. Spectrum2_001146

101. Spectrum3_000370

102. Spectrum4_000304

103. Spectrum5_000795

104. Lopac-c-0768

105. N,n-bis(beta-chloroethyl)-n',o-propylenephosphoric Acid Ester Diamide

106. N,n-bis(beta-chloroethyl)-n',o-trimethylenephosphoric Acid Ester Diamide

107. Epitope Id:131782

108. 2-(bis(2-chloroethyl)amino)tetrahydro-2h-1,3,2-oxazophosphorine 2-oxide

109. C 0768

110. N,n-bis-(beta-chloraethyl)-n',o-propylen-phosphorsaeure-ester-diamid [german]

111. Schembl4346

112. (.+/-.)-cyclophosphamide

113. Lopac0_000238

114. Bspbio_002099

115. Kbiogr_000888

116. Kbioss_001338

117. Divk1c_000246

118. Spbio_001071

119. Cyclophosphamide [hsdb]

120. Gtpl7154

121. Schembl4345553

122. Dtxsid5020364

123. Schembl10262910

124. Cmsmoczeivjldb-uhfffaoysa-

125. Kbio1_000246

126. Kbio2_001338

127. Kbio2_003906

128. Kbio2_006474

129. Kbio3_001319

130. Cyclophospamide Monohydrate

131. Cyclophosphamide [who-dd]

132. Wln: T6mpotj Bo Bn2g2g

133. Cyclophosphamide, Anhydrous

134. Ninds_000246

135. 2-(bis(2-chloroethyl)amino)-1,3,2-oxazaphosphinane 2-oxide

136. Cyclophosphamide Lyophilized

137. Hms2090a12

138. Hms3260p17

139. Hms3715j05

140. Pharmakon1600-01500213

141. Amy33449

142. Bcp02139

143. Tox21_500238

144. 2-chloro-5-methylbenzanilide

145. Bdbm50237604

146. N,n-bis(2-chloroethyl)-2-oxo-1,3,2lambda5-oxazaphosphinan-2-amine

147. N,n-bis-(beta-chloraethyl)-n',o-propylen-phosphorsaeure-ester-diamid

148. Nsc273033

149. Nsc273034

150. Nsc756711

151. Stk177249

152. 2h-1,3,2-oxazaphosphorine, 2-(bis(2-chloroethyl)amino)tetrahydro-, 2-oxide

153. Akos005410738

154. Cs-1425

155. Cyclophosphamide Anhydrous [mi]

156. Db00531

157. Lp00238

158. Nsc-273033

159. Nsc-273034

160. Sdccgsbi-0050226.p004

161. Idi1_000246

162. N,3,2-oxazaphosphorin-2-amine-2-oxide

163. N,o-propylen-phosphorsaeure-ester-diamid

164. Ncgc00015209-01

165. Ncgc00015209-02

166. Ncgc00015209-03

167. Ncgc00015209-04

168. Ncgc00015209-06

169. Ncgc00015209-07

170. Ncgc00015209-08

171. Ncgc00015209-09

172. Ncgc00015209-12

173. Ncgc00015209-28

174. Ncgc00091741-02

175. Ncgc00091741-03

176. Ncgc00260923-01

177. As-73255

178. Bp-25411

179. Hy-17420

180. Nci60_002097

181. N,o-propylenephosphoric Acid Ester Diamide

182. Sbi-0050226.p003

183. Db-082057

184. N,o-propylene-phosphoric Acid Ester Diamide

185. A2343

186. Eu-0100238

187. Ft-0624276

188. Ft-0665387

189. N,o-trimethylenephosphoric Acid Ester Diamide

190. En300-74526

191. C07888

192. D07760

193. Ab00053446-09

194. Ab00053446-11

195. Ab00053446-12

196. Ab00053446_13

197. Ab00053446_14

198. Ab00053446_15

199. 005c978

200. Q408524

201. W-60377

202. N,o-propylenephosphoric Acid Ester Amide Monohydrate

203. Sr-01000075737-1

204. Sr-01000075737-6

205. W-105248

206. Brd-a09722536-002-02-4

207. 2-(bis(2-chloroethyl)amino)-1,3,2-oxazaphosphinane2-oxide

208. 2-[bis(2-chloroethyl)amino]-1,3,2??-oxazaphosphinan-2-one

209. 2-[bis(2-chloroethyl)amino]-1,3,2$l^{5}-oxazaphosphinan-2-one

210. N,n-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide #

211. 2-(di(2-chloroethyl)amino)-2-phospha(v)-tetrahydro-2h-1,3-oxazine-2-one

212. 2-[bis(2-chloroethyl)amino]tetrahydro-1,3,2-oxazaphosphorin-2-oxide

213. 2h-1,2-oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide

214. 2h-1,3,2-oxazaphosphorine, 2-(bis(2-chloroethyl)amino)tetrahydro-,2-oxide

215. N,n-bis(.beta.-chloroethyl)-n',o-trimethylenephosphoric Acid Ester Diamide

216. N,n-bis(2-chloroethyl)tetrahydro-2h-1,3,2-oxazaphosphorin-2-amine-2-oxide

217. N,n-bis-(.beta.-chloraethyl)-n',o-propylen-phosphorsaeure-ester-diamid

218. (+/-)-2-(bis(2-chloroethyl)amino)tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide

219. (+/-)-2-[bis(2-chloroethyl)amino]tetrahydro-2 H-1,3,2-oxazaphosphorine 2-oxide

220. (r)-2-[bis(2-chloroethyl)amino]tetrahydro-2h-1,3,2-oxazaphosphorin 2-oxide

221. (s)-2-[bis(2-chloroethyl)amino]tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide

222. 2h-1,2-oxazaphosphorin-2-amine, N,n-bis(2-chloroethyl)tetrahydro-, 2-oxide

223. 2h-1,2-oxazaphosphorin-2-amine, N,n-bis(2-chloroethyl)tetrahydro-, 2-oxide, (+)-

224. 2h-1,2-oxazaphosphorin-2-amine, N,n-bis(2-chloroethyl)tetrahydro-, 2-oxide, (-)-

225. 2h-1,2-oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, Monohydrate

226. N,n-bis(2-chloroethyl)-2-oxo-1-oxa-3-aza-2$l^{5}-phosphacyclohexan-2-amine

227. Phosphorodiamidic Acid,n-bis(2-chloroethyl)-n'-(3-hydroxypropyl)-, Intramol. Ester

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₇H₁₅Cl₂N₂O₂P
Molecular Weight	261.08 g/mol
XLogP3	0.6
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	5
Exact Mass	260.0248201 g/mol
Monoisotopic Mass	260.0248201 g/mol
Topological Polar Surface Area	41.6 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	212
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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 2
Drug Name	Cyclophosphamide
PubMed Health	Cyclophosphamide
Drug Classes	Alkylating Agent, Antineoplastic Agent, Antirheumatic, Cytotoxic, Nitrogen Mustard
Drug Label	Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2P H2O and a molecular weight of 279.1. The chemical name for cy...
Active Ingredient	Cyclophosphamide
Dosage Form	Injectable; Tablet; Capsule
Route	Injection; Oral
Strength	500mg/vial; 25mg; 50mg; 2gm/vial; 1gm/vial
Market Status	Prescription
Company	Baxter Hlthcare; Roxane

2 of 2
Drug Name	Cyclophosphamide
PubMed Health	Cyclophosphamide
Drug Classes	Alkylating Agent, Antineoplastic Agent, Antirheumatic, Cytotoxic, Nitrogen Mustard
Drug Label	Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2P H2O and a molecular weight of 279.1. The chemical name for cy...
Active Ingredient	Cyclophosphamide
Dosage Form	Injectable; Tablet; Capsule
Route	Injection; Oral
Strength	500mg/vial; 25mg; 50mg; 2gm/vial; 1gm/vial
Market Status	Prescription
Company	Baxter Hlthcare; Roxane

4.2 Therapeutic Uses

Alkylating Agents; Antineoplastic Agents, Alkylating; Antirheumatic Agents; Carcinogens; Immunosuppressive Agents; Mutagens; Teratogens

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

MEDICATION (VET): ... CYTOTOXIC AGENT FOR CARCINOMA, LEUKOSIS, ADENOMA, FIBROMA, & MIXED MAMMARY TUMORS OF DOGS ... MYCOTIC DERMATITIS ... OF SHEEP & TRYPANOSOMIASIS ... OF CATTLE ... ALSO ... CYTOTOXIC ... & IMMUNOSUPPRESSIVE IN RATS ... AGAINST EXPTL ALLERGIC ENCEPHALOMYELITIS.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 148

The clinical spectrum of activity for cyclophosphamide is very broad. It is an essential component of many effective drug combinations for non-Hodgkin's lymphomas. Complete remissions & presumed cures have been reported when cyclophosphamide was given as a single agent for Burkitt's lymphoma. It is frequently used in combination with methotrexate (or doxorubicin) & fluorouracil as adjuvant therapy after surgery for carcinoma of the breast. Notable advantages of this drug are the availability of the oral route of admin & the possibility of giving fractionated doses over prolonged periods. For these reasons it possesses a versatility of action that allows an intermediate range of use, between that of the highly reactive iv mechlorethamine & that of oral chlorambucil. Beneficial results have been obtained in multiple myeloma; chronic lymphocytic leukemia; carcinomas of the lung, breast, cervix, & ovary; & neuroblastoma, retinoblastoma, & other neoplasms of childhood. Because of its potent immunosuppressive properties, cyclophosphamide has received considerable attention for the control of organ refection after transplantation & in nonneoplastic disorders associated with altered immune reactivity, including Wegener's granulomatosis, rheumatoid arthritis, & the nephrotic syndrome in children.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1395

Furosemide may improve, renal blood flow, decrease resorption of sodium and chloride, and increase free water excretion. The initial dose of furosemide is 2 mg/kg, IV. This dosage can be doubled or tripled if urine output does not increase within 1 hr. However, if there is no response to 6 mg/kg, another approach should be tried. If effective, furosemide can be given parenterally at 2 mg/kg, tid., to maintain a diuresis.

Aiello, S.E. (ed). The Merck Veterinary Manual. 8th ed. Merck & Co., Inc., National Publishing Inc., Philadelphia, PA. 1998., p. 1732

For more Therapeutic Uses (Complete) data for CYCLOPHOSPHAMIDE (30 total), please visit the HSDB record page.

4.3 Drug Warning

Appropriate caution is advised when the drug is considered for use in ... /nonneoplastic/ conditions, not only because of its acute toxic effects but also because of its high potential for inducing sterility, teratogenic effects, & leukemia. ... Administration of the drug should be interrupted at the first indication of dysuria or hematuria. The syndrome of inappropriate secretion of antidiuretic hormone (ADH) has been observed in patients receiving cyclophosphamide, usually at doses higher than 50 mg/kg. It is important to be aware of the possibility of water intoxication, since these patients are usually vigorously hydrated.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1395

POTENTIAL ADVERSE EFFECTS ON FETUS: Various fetal malformations, especially skeletal defects and dysmorphic features, but other chemotherapeutic agents given concurrently. POTENTIAL SIDE EFFECTS ON BREAST-FED INFANT: Transient neutropenia from cyclophosphamide with prednisone and vincristine. Potential mutagenicity, carcinogenicity, adverse effects on fetus. FDA Category: D (D = There is evidence of human fetal risk, but the potential benefits from use in pregnant women may be acceptable despite the potential risks (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective.)) /from Table II/

PMID:2195076 Stockton DL and Paller AS; J Am Acad Dermatol 23 (1):87-103 (1990)

Drugs that are Contraindicated during Breast-Feeding: Cyclophosphamide: Possible immune suppression; unknown effect on growth or association with carcinogenesis; neutropenia. /from Table 1./

Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 138 (1994)

THE DRUG IS MOST TOXIC TO THE HUMAN FETUS DURING 1ST 3 MO & CONGENITAL ABNORMALITIES HAVE BEEN DETECTED AFTER IV INJECTION OF LARGE DOSES TO PREGNANT WOMEN DURING THIS PERIOD OF PREGNANCY. /MONOHYDRATE/

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V9 146 (1975)

For more Drug Warnings (Complete) data for CYCLOPHOSPHAMIDE (27 total), please visit the HSDB record page.

4.4 Drug Indication

Cyclophosphamide is indicated for the treatment of malignant lymphomas, multiple myeloma, leukemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast. It is also indicated for the treatment of biopsy-proven minimal change nephrotic syndrome in pediatric patients.

Treatment of malignant diseases

Treatment of all malignant neoplasms

5 Pharmacology and Biochemistry

5.1 Pharmacology

Cyclophosphamide is an antineoplastic in the class of alkylating agents and is used to treat various forms of cancer. Alkylating agents are so named because of their ability to add alkyl groups to many electronegative groups under conditions present in cells. They stop tumor growth by cross-linking guanine bases in DNA double-helix strands - directly attacking DNA. This makes the strands unable to uncoil and separate. As this is necessary in DNA replication, the cells can no longer divide. In addition, these drugs add methyl or other alkyl groups onto molecules where they do not belong which in turn inhibits their correct utilization by base pairing and causes a miscoding of DNA. Alkylating agents are cell cycle-nonspecific. Alkylating agents work by three different mechanisms all of which achieve the same end result - disruption of DNA function and cell death.

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.)

Myeloablative Agonists

Agents that destroy bone marrow activity. They are used to prepare patients for BONE MARROW TRANSPLANTATION or STEM CELL TRANSPLANTATION. (See all compounds classified as Myeloablative Agonists.)

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

Mutagens

Chemical agents that increase the rate of genetic mutation by interfering with the function of nucleic acids. A clastogen is a specific mutagen that causes breaks in chromosomes. (See all compounds classified as Mutagens.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CYCLOPHOSPHAMIDE ANHYDROUS

5.3.2 FDA UNII

6UXW23996M

5.3.3 Pharmacological Classes

Alkylating Drug [EPC]; Alkylating Activity [MoA]

5.4 ATC Code

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01A - Alkylating agents

L01AA - Nitrogen mustard analogues

L01AA01 - Cyclophosphamide

5.5 Absorption, Distribution and Excretion

Absorption

After oral administration, peak concentrations occur at one hour.

Route of Elimination

Cyclophosphamide is eliminated primarily in the form of metabolites. 10-20% is excreted unchanged in the urine and 4% is excreted in the bile following IV administration.

Volume of Distribution

30-50 L

Clearance

Total body clearance = 63 7.6 L/kg.

Cyclophosphamide is well absorbed orally.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1395

PLACENTAL TRANSFER OF (14)CARBON-CYCLOPHOSPHAMIDE HAS BEEN DEMONSTRATED IN MICE; AND A POSITIVE CORRELATION BETWEEN THE ALKYLATION OF EMBRYONIC DNA AND PRODUCTION OF CONGENITAL ABNORMALITIES IN MICE HAS BEEN REPORTED. A SIMILAR CORRELATION HAS BEEN FOUND FOR NUCLEAR-DNA-DEPENDENT RNA POLYMERASES IN RAT EMBRYOS. IN MOST SPECIES, CYCLOSPHSPHAMIDE IS RAPIDLY ABSORBED, METABOLIZED AND EXCRETED. IN RATS, THE SPECIFIC ACTIVITY IN TISSUES IS HIGHEST WITHIN 20-30 MIN FOLLOWING IP INJECTION; UP TO 75% OF THE RADIOACTIVITY IS EXCRETED WITHIN 5-8 HR. /MONOHYDRATE/

AFTER ITS IV INJECTION, THE DRUG IS RAPIDLY ABSORBED FROM THE BLOOD. IN PATIENTS RECEIVING 6.7-80 MG/KG BODY WT PER DAY OF RING LABELLED CYCLOPHOSPHAMIDE, RADIOACTIVITY WAS DISTRIBUTED RAPIDLY TO ALL TISSUES: ITS HALF LIFE IN THE PLASMA WAS 6.5 HOURS. NO RADIOACTIVITY WAS FOUND IN THE EXPIRED AIR OR FECES. RECOVERY OF RADIOACTIVITY IN URINE HAS BEEN REPORTED TO BE BETWEEN 50-68%, MAINLY IN THE FORM OF CARBOXYPHOSPHAMIDE AND PHOSPHORAMIDE MUSTARD; 10-40% OF THE DRUG WAS EXCRETED UNCHANGED; AND 56% OF THE REACTIVE METABOLITES WERE BOUND TO PLASMA PROTEINS. /MONOHYDRATE/

In a cross sectional study, the urine of 20 hospital workers occupationally exposed to cyclophosphamide and 21 unexposed controls was monitored for excretion of cyclophosphamide. During the week in which samples were collected, most of the workers handled cyclophosphamide fewer than 5 times and the amount handled each time ranged from 100-1000 mg (mean + or - 350 mg). All workers claimed to have taken regular safety precautions; ie, at least wearing gloves during handling. The drug was identified in 5 cases (range: 0.7-2.5 ug cyclophosphamide excreted/24 hr urine). A clear relationship between cyclophosphamide handling and urinary detection was shown. 4 of 5 persons with detectable urinary cyclophosphamide had handled cyclophosphamide 10 times or more during the week.

PMID:3744569 Evelo CTA et al; Int Arch Occup Environ Health 58: 151-5 (1986)

For more Absorption, Distribution and Excretion (Complete) data for CYCLOPHOSPHAMIDE (7 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Metabolism and activation occurs at the liver. 75% of the drug is activated by cytochrome P450 isoforms, CYP2A6, 2B6, 3A4, 3A5, 2C9, 2C18, and 2C19. The CYP2B6 isoform is the enzyme with the highest 4-hydroxylase activity. Cyclophosphamide undergoes activation to eventually form active metabolites, phosphoramide mustard and acrolein. Cyclophosphamide appears to induce its own metabolism which results in an overall increase in clearance, increased formation of 4-hydroxyl metabolites, and shortened t1/2 values following repeated administration.

... /Cyclophosphamide/ is activated by the hepatic cytochrome P450 system. Cyclophosphamide is first converted to 4-hydroxycyclophosphamide, which is in a steady state with the acyclic tautomer aldophosphamide. In vitro studies with human liver microsones & cloned P450 isoenzymes have shown that cyclophosphamide is activated by the CYP2B group of P450 isoenzymes... . 4-hydroxycyclophosphamide may be oxidized further by aldehyde oxidase either in liver or in tumor tissue & perhaps by other enzymes, yielding the metabolites carboxyphosphamide & 4-ketocyclophsphamide, neither of which possesses significant biological activity. It appears that hepatic damage is minimized by theses secondary reactions, whereas significantl amoutns of the active metabolies, such as 4-hydroxycyclophosphamide & its tautomer, aldophosphamed, are transported to the target sites by the circulatory system. In tumor cells, the aldophosphamide cleaves spontaneously, generating stoichiometric amounts of phosphoramide mustard & acrolein. The former is believed to be responsible for antitumor effects. The latter cmpd may be responsible for the hemorrhagic cystitis seen during therapy with cyclophosphamide. Cystitis can be reduced in intensity or prevented by the pareneteral admin of mesna, a sulfhydryl cmpd that reacts readily with acrolein in the acid environment of the urinary tract. ... Urinary & fecal recovery of unchanged cyclophosphamide is minimal after iv admin. Maximal concns in plasma are achieved 1 hr after oral admin, & the half-life in plasma is about 7 hr.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1395

SHEEP WERE ORALLY DOSED WITH CYCLOPHOSPHAMIDE. IN COLLECTED URINE, 2 METABOLITES WERE OBSERVED AND CHARACTERIZED AS O-(2-CARBOXYETHYL)-N,N-BIS (2-CHLOROETHYL)PHOSPHORODIAMIDATE & 2-(BIS (2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZOPHOSPHORINE 2,4-DIOXIDE (4-KETOCYCLOPHOSPHAMIDE).

Menzie, C. M. Metabolism of Pesticides, An Update. U.S. Department of the Interior, Fish, Wild-life Service, Special Scientific Report - Wildlife No. 184, Washington, DC: U.S. Government Printing Office, l974., p. 119

A REACTIVE METABOLITE, N,N-BIS-(2-CHLOROETHYL)PHOSPHORODIAMIDIC ACID, WHICH POSSESSES POTENT ALKYLATING & CYTOTOXIC PROPERTIES, HAS RECENTLY BEEN ISOLATED FROM THE OXYGENATION PRODUCTS OF CYCLOPHOSPHAMIDE AND MOUSE LIVER MICROCHROMOSOMES.

The Chemical Society. Foreign Compound Metabolism in Mammals Volume 3. London: The Chemical Society, 1975., p. 473

Cyclophosphamide is well absorbed orally, and peak plasma levels appear about one hour after oral use. It is also administered intravenously. This drug is metabolized in the liver to the cytotoxic metabolite, 4-hydroxycyclophosphamide, which is in equilibrium with the acyclic tautomer, aldophosphamide. Although the major fraction of these metabolites is oxidized further to inactive products, some aldophosphamide is converted to phophoramidemustard, which alkylates DNA, and to acrolein.

American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 2012

For more Metabolism/Metabolites (Complete) data for CYCLOPHOSPHAMIDE (8 total), please visit the HSDB record page.

5.7 Biological Half-Life

3-12 hours

Maximal concns in plasma are achieved 1 hr after oral admin, & the half-life in plasma is about 7 hr.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1395

5.8 Mechanism of Action

Alkylating agents work by three different mechanisms: 1) attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, preventing DNA synthesis and RNA transcription from the affected DNA, 2) DNA damage via the formation of cross-links (bonds between atoms in the DNA) which prevents DNA from being separated for synthesis or transcription, and 3) the induction of mispairing of the nucleotides leading to mutations.

The chemotherapeutic alkylating agents have in common the property of becoming strong electrophiles through the formation of carbonium ion intermediates or of transition complexes with the target molecules. These reactions result in the formation of covalent linkages by alkylation of various nucleophilic moieties such as phosphate, amino, sulfhydryl, hydroxyl, carboxyl, & imidazole groups. The chemotherapeutic & cytotoxic effects are directly related to the alkylation of DNA. The 7 nitrogen atom of guanine is particularly susceptible to the formation of a covalent bond with bifunctional alkylating agents & may well represent the key target that determines their biological effects. It must be appreciated, however, that other atoms in the purine & pyrimidine bases of DNA- particularly, the 1 & 3 nitrogens of adenine, the 3 nitrogen of cytosine, & the 6 oxygen of guanine- also may be alkylated, as will be the phosphate atoms of the DNA chains & amino & sulfhydryl groups of proteins. /Alkylating agents/

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1389

Cyclophosphamide can be used to cause immunologically mediated regression of the immunogenic, cyclophosphamide-resistant L5178Y lymphoma in syngeneic and semisyngeneic mice (B6D2F1 (C57BL/6 x DBA/2) females). In order to cause tumor regression it was necessary to give cyclophosphamide (125-200 mg/kg of body wt, iv shortly before or shortly after tumor implantation. Regardless of whether cyclophosphamide was given before or after tumor implantation, tumor regression was associated with the presence in the spleen of an incr number of Lyt-2+ T-cells capable of passively transferring immunity to tumor bearing recipients. This augmented level of immunity was sustained throughout the period of tumor regression. In contrast, a lower level of concomitant immunity generated by control tumor bearers decayed after day 12 of tumor growth. Because the therapeutic effect of cyclophosphamide could be inhibited by passive transfer of L3T4+ T-cells from normal donor mice it is apparent that the therapeutic effect of cyclophosphamide is based on its ability to preferentially destroy L3T4+ suppressor T-cells. These putative precursor suppressor T-cells were regenerated 4 days after being destroyed by cyclophosphamide.

PMID:2522344 Awwad M, North RJ; Cancer Res 49 (7): 1649-54 (1989)

These studies enable the pattern of emesis and nausea for 3 days following high-dose cyclophosphamide to be described and give some insight into the mechanisms of emesis which may be operating. Nausea and vomiting induced by cyclophosphamide-based chemotherapy has long latency of onset (8-13 hr) and continues for at least 3 days. These findings are of particular importance as many of these patients receive chemotherapy as outpatients and emphasize the need for appropriate anti-emetic prophylaxis for patients at home. Ondansetron was extremely effective over this time in the control of emesis and nausea. These results suggest that high-dose cyclophosphamide-induced emesis over days 1-3 is largely mediated via 5-hydroxytryptamine (5-HT) and 5-HT3 receptors.

Beck TM; Anticancer Dugs 6 (2): 237-42 (1995)

The most likely mechanism by which cyclophosphamide augments immune responses relates to preferential elimination of suppressor and relative sparing of effector and helper cells. Thus, precursors and mature murine suppressor cells are very sensitive to cyclophosphamide whereas the mature effector cells are relatively insensitive ... . Cyclophosphamide induced immunological regression of murine leukemia is reversed by the infusion of normal spleen cells as a source of precursors of suppressor cells ... . Memory and helper T cells are relatively resistant to the cytotoxic effect of cyclophosphamide ... . NK activity against YAC lymphoma targets by non T and non B cells is depressed by cyclophosphamide ... .

Foye, W.O. (ed.). Cancer Chemotherapeutic Agents. ACS Professional Reference Book. Washington, D.C.: American Chemical Society, 1995., p. 469

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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DOSAGE - INJECTABLE;INJECTION - 100MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12142

DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12142

DOSAGE - INJECTABLE;INJECTION - 200MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12142

DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12142

DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12142

DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 203856

DOSAGE - CAPSULE;ORAL - 50MG

USFDA APPLICATION NUMBER - 203856

DOSAGE - SOLUTION;INTRAVENOUS - 1GM/5ML (200M...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML)

USFDA APPLICATION NUMBER - 212501

DOSAGE - SOLUTION;INTRAVENOUS - 2GM/10ML (200...DOSAGE - SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML)

USFDA APPLICATION NUMBER - 212501

DOSAGE - SOLUTION;INTRAVENOUS - 500MG/2.5ML (...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)

USFDA APPLICATION NUMBER - 212501

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ABOUT THIS PAGE

Cyclophosphamide Manufacturers

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

Cyclophosphamide Suppliers

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

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

Cyclophosphamide USDMF

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

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

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

Cyclophosphamide CEP

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

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

Cyclophosphamide WC

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

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

Cyclophosphamide 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 Cyclophosphamide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cyclophosphamide GMP

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

Cyclophosphamide CoA

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

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

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

38 API Suppliers

21 USDMF

6 CEP/COS

6 EU WC

17 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

314 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

139 FDF Dossiers

79 FDA Orange Book

15 Europe

8 Canada

9 Australia

6 South Africa

22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 25MG

CAPSULE;ORAL - 50MG

SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML)

SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML)

SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)

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EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders

32 Direct Compression

18 Thickeners and Stabilizers

17 Co-Processed Excipients

16 Chewable & Orodispersible Aids

16 Lubricants & Glidants

14 Taste Masking

12 Disintegrants & Superdisintegrants

12 Granulation

INJECTABLE;INJECTION - 100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 200MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons