Cyclophosphamide

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ACTIVE PHARMA INGREDIENTS

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1137 Drugs in Development

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FINISHED DOSAGE FORMULATIONS

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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INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML), SOLUTION;INTRAVENOUS - 2GM/10ML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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1 Minakem, 2 Rochem International Inc, 18 SPI Pharma, 7 DKSH, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 ACG Worldwide, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 4 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 1 Ideal Cures, 3 Ingredion Pharma Solutions, 11 Kerry, 1 Keval Exports, 3 Lonza Capsugel, 11 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 17 Roquette, 2 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 Silverline Chemicals, 1 Valens Pharmachem, 2 Vasa Pharmachem

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PATENTS & EXCLUSIVITIES

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15 US Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 203856 / DOSAGE - CAPSULE;ORAL - 25MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYCLOPHOSPHAMIDE(UNII: 8N3DW7272P) (CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M)	CYCLOPHOSPHAMIDE ANHYDROUS	25mg

Inactive Ingredients

Ingredient Name	ANI Pharmaceuticals, Inc.	STI Pharma LLC	Avera McKennan Hospital	Cipla USA Inc.
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
ISOPROPYL ALCOHOL(ND2M416302)
METHYL ALCOHOL(Y4S76JWI15)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Setid 4d188a0e A2cc 49a4 Abe9 A3b82f104267 Applno 203856 Form Capsule Oral Dosage 25mg - Drug Product Composition: Cyclophosphamide