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- 60MG, INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR - 10MG/0.7ML (10MG/0.7ML), INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION -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30MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or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

Filters

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USFDA APPLICATION NUMBER - 22195 / DOSAGE - SOLUTION;ORAL - 10MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	30mg

Inactive Ingredients

Ingredient Name	ANI Pharmaceuticals, Inc.	Caraco Pharmaceutical Laboratories, Ltd.	Nostrum Laboratories, Inc.	Qualitest Pharmaceuticals	VistaPharm, Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ATLANTIC BIOLOGICALS CORP.	Precision Dose Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
EDETATE DISODIUM ANHYDROUS(8NLQ36F6MM)
EDETATE DISODIUM(7FLD91C86K)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 40(WZB9127XOA)
GLYCERIN(PDC6A3C0OX)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
WATER(059QF0KO0R)

Drug Product Composition: Di(morphine) dihydrogen sulfate pentahydrate