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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 23 NDC API, 9 Listed Suppliers, $ API Reference Price

20 API Suppliers
11 USDMF
7 CEP/COS
1 JDMF
2 KDMF
23 NDC API
9 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 75 FDA Orange Book, 36 Europe, 42 Canada, 40 Australia, 5 South Africa, 20 Listed Dossiers

218 FDF Dossiers
75 FDA Orange Book
36 Europe
42 Canada
40 Australia
5 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
INJECTABLE;INJECTION - 0.2MG/ML
INJECTABLE;INJECTION - 0.5MG/0.5ML
INJECTABLE;INJECTION - 10MG/ML
INJECTABLE;INJECTION - 1MG/ML
INJECTABLE;INJECTION - 2MG/ML
INJECTABLE;INJECTION - 4MG/ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 2MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG
TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Evonik
2 Rochem International Inc
14 SPI Pharma
2 Seqens
4 DKSH
1 Jai Radhe Sales
4 Faran Shimi Pharmaceutical
6 Boai NKY Pharmaceuticals Ltd
11 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 ACG Worldwide
11 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
26 BASF
1 Clariant
12 Corel Pharma Chem
6 DFE Pharma
2 Finar
11 Gangwal Chemicals
1 Huzhou Sunflower Pharmaceutical
7 Ideal Cures Pvt Ltd
2 Ingredion Pharma Solutions
39 Kerry
3 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
3 Pharmatrans-Sanaq
5 Pluviaendo
3 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
24 Roquette
12 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 The Dow Chemical Company
2 Ulanqab Kema New Material
1 Valens Pharmachem
3 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 36 Controlled & Modified Release, 29 Film Formers & Plasticizers, 28 Solubilizers, 27 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 21 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 18 Taste Masking, 18 Topical, 13 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
46 Finished Drug Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

marketPlace
1 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 US Exclusivities, 12 Health Canada Patents

patents
14 US Patents
2 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 3 USP , 5 Others

otherSolutions
2 EDQM
3 USP
5 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 7,574

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

218

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,347,796

Annual Reports (USD Million)

Finished Drug Prices

292 RELATED EXCIPIENT COMPANIES

503EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 71-68-1, Hydromorphone hcl, Dilaudid, Palladone, Hymorphan, Exalgo

Molecular Formula

C₁₇H₂₀ClNO₃

Molecular Weight

321.8 g/mol

InChI Key

XHILEZUETWRSHC-NRGUFEMZSA-N

FDA UNII

L960UP2KRW

An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.

1 2D Structure

Hydromorphone Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aR,7aR,12bS)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

2.1.2 InChI

InChI=1S/C17H19NO3.ClH/c1-18-7-6-17-10-3-5-13(20)16(17)21-15-12(19)4-2-9(14(15)17)8-11(10)18;/h2,4,10-11,16,19H,3,5-8H2,1H3;1H/t10-,11+,16-,17-;/m0./s1

2.1.3 InChI Key

XHILEZUETWRSHC-NRGUFEMZSA-N

2.1.4 Canonical SMILES

CN1CCC23C4C1CC5=C2C(=C(C=C5)O)OC3C(=O)CC4.Cl

2.1.5 Isomeric SMILES

CN1CC[C@]23[C@@H]4[C@H]1CC5=C2C(=C(C=C5)O)O[C@H]3C(=O)CC4.Cl

2.2 Other Identifiers

2.2.1 UNII

L960UP2KRW

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dihydromorphinone

2. Dilaudid

3. Hydromorphon

4. Hydromorphone

5. Laudacon

6. Palladone

2.3.2 Depositor-Supplied Synonyms

1. 71-68-1

2. Hydromorphone Hcl

3. Dilaudid

4. Palladone

5. Hymorphan

6. Exalgo

7. Dihydromorphinone Hydrochloride

8. Dilaudid-hp

9. L960up2krw

10. Hydromorphone Hydrochloride Cii

11. Nsc-117862

12. Dea No. 9150

13. (4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

14. 4,5-alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

15. Chebi:5791

16. Morphinone, Dihydro-, Hydrochloride

17. Einecs 200-762-6

18. Unii-l960up2krw

19. Nsc 117862

20. Hydromorphone Hydrochloride [usp]

21. Palladone (tn)

22. Dilaudid (tn)

23. (4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

24. Exalgo (tn)

25. 4,5alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

26. Schembl30521

27. Hydromorphone Hydrochloride Usp

28. Chembl1237055

29. Dtxsid90991291

30. Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, Hydrochloride

31. Hydromorphone Hydrochloride (jan/usp)

32. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5alpha)-

33. Hydromorphone Hydrochloride [mi]

34. Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5'-alpha)-

35. Hydromorphone Hydrochloride [jan]

36. Hydromorphone Hydrochloride [mart.]

37. Hydromorphone Hydrochloride [vandf]

38. Hydromorphone Hydrochloride [who-dd]

39. D00839

40. Hydromorphone Hydrochloride [orange Book]

41. Hydromorphone Hydrochloride Cii [usp-rs]

42. Hydromorphone Hydrochloride [ep Monograph]

43. Hydromorphone Hydrochloride [usp Monograph]

44. Q27106892

45. 4,5.alpha.-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

46. Hydromorphone Hydrochloride Solution, Drug Standard, 1.0 Mg/ml In Methanol

47. Hydromorphone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

48. Hydromorphone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

49. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride (1:1), (5.alpha.)

50. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5.alpha.)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₀ClNO₃
Molecular Weight	321.8 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	0
Exact Mass	321.1131712 g/mol
Monoisotopic Mass	321.1131712 g/mol
Topological Polar Surface Area	49.8 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	494
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Exalgo
Drug Label	EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist.Hydromorphone hydrochloride USP is 4,5-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that...
Active Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	32mg; 12mg; 16mg; 8mg
Market Status	Prescription
Company	Mallinckrodt

2 of 4
Drug Name	Hydromorphone hydrochloride
PubMed Health	Hydromorphone
Drug Classes	Analgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug Label	Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration.Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.The chemical name of hydromorphone hydrochloride...
Active Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Injectable; Solution
Route	Injection; Oral
Strength	2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market Status	Prescription
Company	Hospira; Actavis Labs Fl; Mallinckrodt; Roxane; Lannett; Elite Labs; Akorn; Barr

3 of 4
Drug Name	Exalgo
Drug Label	EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist.Hydromorphone hydrochloride USP is 4,5-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that...
Active Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	32mg; 12mg; 16mg; 8mg
Market Status	Prescription
Company	Mallinckrodt

4 of 4
Drug Name	Hydromorphone hydrochloride
PubMed Health	Hydromorphone
Drug Classes	Analgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug Label	Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration.Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.The chemical name of hydromorphone hydrochloride...
Active Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Injectable; Solution
Route	Injection; Oral
Strength	2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market Status	Prescription
Company	Hospira; Actavis Labs Fl; Mallinckrodt; Roxane; Lannett; Elite Labs; Akorn; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

API SUPPLIERS

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USDMF

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CEP/COS

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DRUG PRODUCT COMPOSITIONS

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