Mycophenolate Mofetil

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 29 USDMF, 18 CEP/COS, 2 JDMF, 9 EU WC, 10 KDMF, 22 NDC API, 32 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

144 Drugs in Development

144 Drugs in Development

FINISHED DOSAGE FORMULATIONS

161 FDF Dossiers, 45 FDA Orange Book, 57 Europe, 12 Canada, 13 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 250MG, TABLET;ORAL - 500MG, FOR SUSPENSION;ORAL - 200MG/ML

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 19 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 26 BASF, 2 CD Formulation, 2 Clariant, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 12 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 25 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 34 Thickeners and Stabilizers, 29 Controlled & Modified Release, 26 Solubilizers, 23 Film Formers & Plasticizers, 23 Topical, 20 Direct Compression, 19 Disintegrants & Superdisintegrants, 19 Granulation, 17 Parenteral, 17 Lubricants & Glidants, 15 Co-Processed Excipients, 15 Taste Masking, 10 Rheology Modifiers, 10 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 Emulsifying Agents, 8 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

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1 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 36 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

13 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 4 Others

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USFDA APPLICATION NUMBER - 50759 / DOSAGE - FOR SUSPENSION;ORAL - 200MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MYCOPHENOLATE MOFETIL HYDROCHLORIDE(UNII: UXH81S8ZVB) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)	MYCOPHENOLIC ACID	500mg in 20
MYCOPHENOLATE MOFETIL(UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)	MYCOPHENOLATE MOFETIL	500mg \| 250mg \| 200mg in 1

Inactive Ingredients

Ingredient Name	Genentech, Inc.	airis PHARMA Private Limited	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
ANHYDROUS CITRIC ACID(XF417D3PSL)
ASPARTAME(Z0H242BBR1)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROCHLORIC ACID(QTT17582CB)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K90(RDH86HJV5Z)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)

Setid 37241e87 4af4 4dc3 A1aa Ea6f20d8dc40 Applno 50759 Form For Suspension Oral Dosage 200mg Ml - Drug Product Composition: Mycophenolate Mofetil