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- 60MG, INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR - 10MG/0.7ML (10MG/0.7ML), INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION -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30MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or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

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Veranova	U.S.A	VERANOVA LP	21588	MORPHINE SULFATE USP	2008-04-30	Active	II	Complete	2014-08-29	2014-08-18
28/10/2024	Noramco	U.S.A	NORAMCO LLC	6967	MORPHINE SULFATE	1987-05-08	Active	II	Complete	2013-02-05	2012-11-23

Di(morphine) Dihydrogen Sulfate Pentahydrate

Di(morphine) dihydrogen sulfate pentahydrate

ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

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

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

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

INJECTABLE;INJECTION - 15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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