Morphine sulfate pentahydrate

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ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 12 USDMF, 6 CEP/COS, 4 KDMF, 14 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

589 FDF Dossiers, 223 FDA Orange Book, 146 Europe, 53 Canada, 81 Australia, 22 South Africa, 64 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR - 10MG/0.7ML (10MG/0.7ML), INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION - 8MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 130MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, CAPSULE, EXTENDED RELEASE;ORAL - 70MG, CAPSULE, EXTENDED RELEASE;ORAL - 80MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 100MG/5ML, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 20MG/5ML, TABLET;ORAL - 15MG, TABLET;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 12 Evonik, 4 Rochem International Inc, 18 SPI Pharma, 23 DKSH, 2 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 13 Kirsch Pharma, 4 ACG Worldwide, 15 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 36 BASF, 1 Bioplus Life Sciences, 4 CD Formulation, 2 Clariant, 17 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 4 Finar, 12 Gangwal Chemicals, 14 Ideal Cures, 3 Ingredion Pharma Solutions, 26 Kerry, 1 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 9 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 15 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 79 Coating Systems & Additives, 54 Controlled & Modified Release, 48 Thickeners and Stabilizers, 43 Parenteral, 39 Solubilizers, 39 Topical, 38 Direct Compression, 32 Granulation, 30 Taste Masking, 27 Film Formers & Plasticizers, 21 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 15 Co-Processed Excipients, 15 Disintegrants & Superdisintegrants, 13 Rheology Modifiers, 12 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 121 News #PharmaBuzz

GLOBAL SALES INFORMATION

26 US Medicaid Prescriptions, 162 Regulatory FDF Prices

MARKET PLACE

21 APIs, 19 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 11 Others

$ Xls

Filters

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USFDA APPLICATION NUMBER - 20616 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 70MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	20mg

Inactive Ingredients

Ingredient Name	Actavis Kadian LLC	Actavis Pharma, Inc.	Allergan, Inc.	Bryant Ranch Prepack	Lake Erie Medical DBA Quality Care Products LLC	Par Pharmaceutical Inc.	St Marys Medical Park Pharmacy
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
DIETHYL PHTHALATE(UF064M00AF)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
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)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K30(U725QWY32X)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Morphine sulfate pentahydrate