Mycophenolate Mofetil

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ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 29 USDMF, 18 CEP/COS, 2 JDMF, 8 EU WC, 9 KDMF, 17 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 45 FDA Orange Book, 60 Europe, 16 Canada, 13 South Africa, 28 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, 2 Seqens, 17 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 2 Clariant, 10 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 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, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 33 Controlled & Modified Release, 30 Thickeners and Stabilizers, 26 Solubilizers, 24 Film Formers & Plasticizers, 21 Topical, 20 Direct Compression, 19 Disintegrants & Superdisintegrants, 19 Granulation, 17 Parenteral, 17 Lubricants & Glidants, 14 Taste Masking, 13 Co-Processed Excipients, 9 Empty Capsules, 9 Emulsifying Agents, 9 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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21 NEWS #PharmaBuzz

21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 55 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

13 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 4 Others

$ Xls

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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)

Drug Product Composition: Mycophenolate Mofetil