Di(morphine) dihydrogen sulfate pentahydrate

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ACTIVE PHARMA INGREDIENTS

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

625 FDF Dossiers, 223 FDA Orange Book, 169 Europe, 47 Canada, 106 Australia, 20 South Africa, 60 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- 60MG, INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR - 10MG/0.7ML (10MG/0.7ML), INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION -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30MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or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

3 Evonik, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 20 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 15 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 17 Corel Pharma Chem, 5 DFE Pharma, 4 Finar, 12 Gangwal Chemicals, 16 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 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, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

110 Fillers, Diluents & Binders, 78 Coating Systems & Additives, 52 Controlled & Modified Release, 42 Direct Compression, 39 Thickeners and Stabilizers, 35 Solubilizers, 35 Topical, 33 Parenteral, 28 Taste Masking, 27 Granulation, 27 Film Formers & Plasticizers, 22 Lubricants & Glidants, 22 Co-Processed Excipients, 16 Chewable & Orodispersible Aids, 14 Disintegrants & Superdisintegrants, 11 Emulsifying Agents, 9 API Stability Enhancers, 9 Rheology Modifiers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 119 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 186 Finished Drug Prices

MARKET PLACE

15 APIs, 19 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents, 4 US Exclusivities, 26 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 7 Others

$ Xls

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USFDA APPLICATION NUMBER - 20616 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

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

Inactive Ingredients

Ingredient Name	Pfizer Laboratories Div Pfizer Inc	Actavis Kadian LLC	Actavis Pharma, Inc.	Allergan, Inc.	Bryant Ranch Prepack	Lake Erie Medical DBA Quality Care Products LLC	Par Pharmaceutical Inc.	Watson Laboratories, Inc.	St Marys Medical Park Pharmacy
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)
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 BLACK(XM0M87F357)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
FUMARIC ACID(88XHZ13131)
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)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE (FZ989GH94E)
POVIDONE K30(U725QWY32X)
POVIDONES(FZ989GH94E)
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: Di(morphine) dihydrogen sulfate pentahydrate