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ACTIVE PHARMA INGREDIENTS

46 API Suppliers, 18 USDMF, 6 JDMF, 5 EU WC, 14 KDMF, 18 NDC API, 8 VMF, 32 Listed Suppliers, $ API Reference Price

46 API Suppliers
18 USDMF
6 JDMF
5 EU WC
14 KDMF
18 NDC API
8 VMF
32 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

98 FDF Dossiers, 58 FDA Orange Book, 6 Europe, 15 Canada, 8 South Africa, 11 Listed Dossiers

98 FDF Dossiers
58 FDA Orange Book
6 Europe
15 Canada
8 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

drugProductComposition
SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

RELATED EXCIPIENT COMPANIES

2 Actylis

relatedExcipients
2 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 51 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
51 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
4 Finished Drug Prices
1 Annual Reports

MARKET PLACE

19 APIs, 7 FDF Dossiers

marketPlace
19 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

64 US Patents, 7 US Exclusivities, 3 Health Canada Patents

patents
64 US Patents
7 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

Fermion Dexmedetomidine HCl

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 892,458

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

39DRUGS 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)

Annual Reports (USD Million)

177

Finished Drug Prices

2 RELATED EXCIPIENT COMPANIES

2EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 145108-58-3, Dexmedetomidine hcl, Precedex, Dexdomitor, Dexdor, Sileo

Molecular Formula

C₁₃H₁₇ClN₂

Molecular Weight

236.74 g/mol

InChI Key

VPNGEIHDPSLNMU-MERQFXBCSA-N

FDA UNII

1018WH7F9I

A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound.

1 2D Structure

Dexmedetomidine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride

2.1.2 InChI

InChI=1S/C13H16N2.ClH/c1-9-5-4-6-12(10(9)2)11(3)13-7-14-8-15-13;/h4-8,11H,1-3H3,(H,14,15);1H/t11-;/m0./s1

2.1.3 InChI Key

VPNGEIHDPSLNMU-MERQFXBCSA-N

2.1.4 Canonical SMILES

CC1=C(C(=CC=C1)C(C)C2=CN=CN2)C.Cl

2.1.5 Isomeric SMILES

CC1=C(C(=CC=C1)[C@H](C)C2=CN=CN2)C.Cl

2.2 Other Identifiers

2.2.1 UNII

1018WH7F9I

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dexmedetomidine

2. Hydrochloride, Dexmedetomidine

3. Mpv 1440

4. Mpv-1440

5. Mpv1440

6. Precedex

2.3.2 Depositor-Supplied Synonyms

1. 145108-58-3

2. Dexmedetomidine Hcl

3. Precedex

4. Dexdomitor

5. Dexdor

6. Sileo

7. Dexmedetomidine (hydrochloride)

8. Cepedex

9. Sedadex

10. (s)-5-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazole Hydrochloride

11. (+)-medetomidine Hydrochloride

12. Dexmedetomidine Hcl (precedex)

13. Dexmedetomidine Hydrochloride [usan]

14. 4-((s)-alpha,2,3-trimethylbenzyl)imidazole Monohydrochloride

15. D-medetomidine Hydrochloride

16. Chebi:31472

17. 1018wh7f9i

18. Precedex (tn)

19. (s)-4-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazole Hydrochloride

20. 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

21. 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole;hydrochloride

22. 145108-58-3 (hcl)

23. 1h-imidazole, 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-, Monohydrochloride

24. 1h-imidazole, 4-(1-(2,3-dimethylphenyl)ethyl)-, Monohydrochloride, (s)-

25. 1h-imidazole, 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-, Hydrochloride (1:1)

26. (s)-medetomidine Hydrochloride

27. Primadex

28. Unii-1018wh7f9i

29. (s)-4-[1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

30. 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole;hydrochloride

31. Dexmedetomidinehcl

32. Igalmi

33. Mls006011569

34. Schembl406837

35. Chembl2106195

36. Dtxsid40873215

37. Dexmedetomidine Hcl [vandf]

38. Act04745

39. 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

40. Ac-310

41. Hy-17034a

42. Mfcd22683223

43. S2090

44. Akos024457275

45. Akos025402024

46. Bcp9000600

47. Ccg-266849

48. H08d583

49. Dexmedetomidine Hydrochloride (jan/usp)

50. As-12485

51. Dexmedetomidine Hydrochloride [mi]

52. Smr004703327

53. Bcp0726000002

54. Dexmedetomidine Hydrochloride [jan]

55. Am20080946

56. D5062

57. Dexmedetomidine Hydrochloride [mart.]

58. Sw219607-2

59. 4-((s)-a,2,3-trimethylbenzyl)imidazole Hcl

60. Dexmedetomidine Hydrochloride [usp-rs]

61. Dexmedetomidine Hydrochloride [who-dd]

62. D01205

63. Dexmedetomidine Hydrochloride [ema Epar]

64. A808325

65. Dexmedetomidine Hydrochloride [green Book]

66. Dexmedetomidine Hydrochloride [orange Book]

67. Dexmedetomidine Hydrochloride [usp Monograph]

68. Q-100166

69. Q27114321

70. Z1617901127

71. Dexmedetomidine Hydrochloride (ema Epar: Veterinary)

72. (+)-medetomidine Hydrochloride;(s)-medetomidine Hydrochloride

73. (s)-4-(alpha,2,3-trimethybenzyl)-1h-imidazole Hydrochloride

74. (s)-5-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazolehydrochloride

75. 4-((s)-.alpha.,2,3-trimethylbenzyl)imidazole Monohydrochloride

2.4 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₁₃H₁₇ClN₂
Molecular Weight	236.74 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	2
Exact Mass	236.1080262 g/mol
Monoisotopic Mass	236.1080262 g/mol
Topological Polar Surface Area	28.7 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	205
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
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	Dexmedetomidine hydrochloride
PubMed Health	Dexmedetomidine (Injection)
Drug Classes	Analgesic, Anesthetic Adjunct, Sedative
Drug Label	Dexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[...
Active Ingredient	Dexmedetomidine hydrochloride
Dosage Form	Injectable
Route	injection; Injection
Strength	eq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market Status	Tentative Approval; Prescription
Company	Par Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

2 of 4
Drug Name	Precedex
Drug Label	Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t...
Active Ingredient	Dexmedetomidine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market Status	Prescription
Company	Hospira

3 of 4
Drug Name	Dexmedetomidine hydrochloride
PubMed Health	Dexmedetomidine (Injection)
Drug Classes	Analgesic, Anesthetic Adjunct, Sedative
Drug Label	Dexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[...
Active Ingredient	Dexmedetomidine hydrochloride
Dosage Form	Injectable
Route	injection; Injection
Strength	eq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market Status	Tentative Approval; Prescription
Company	Par Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

4 of 4
Drug Name	Precedex
Drug Label	Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t...
Active Ingredient	Dexmedetomidine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market Status	Prescription
Company	Hospira

4.2 Drug Indication

For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.

Alleviation of acute anxiety and fear associated with noise in dogs.

Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Premedication in cats before induction and maintenance of general anaesthesia with ketamine.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs before induction and maintenance of general anaesthesia.

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia.

Treatment of bipolar disorder, Treatment of schizophrenia

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic alpha-2 Receptor Agonists

Compounds that bind to and activate ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Agonists.)

Analgesics, Non-Narcotic

A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)

Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Central alpha-2 Adrenergic Agonist [EPC]; General Anesthesia [PE]; Adrenergic alpha2-Agonists [MoA]

5.3 ATC Code

N05CM18

QN05CM18

API SUPPLIERS

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USDMF

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JDMF

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EU WC

01

Emcure Pharmaceuticals

India

26th North American ISSX

Not Confirmed

02

GLAND PHARMA LIMITED

India

26th North American ISSX

Not Confirmed

03

GLAND PHARMA LIMITED

India

26th North American ISSX

Not Confirmed

04

GLAND PHARMA LIMITED

India

26th North American ISSX

Not Confirmed

05

Pioneer Agro Extracts

India

26th North American ISSX

Not Confirmed

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KDMF

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NDC API

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VMF

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API Reference Price

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K","supplierAddress":"1764 LITCHFIELD TURNPIKE SUITE 202WOODBRIDGE, CT, 06525 USA\/\/MFG-STREM CHEMICALS INC-USA United States","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717007400,"product":"DEXMEDETOMIDINE HYDROCHLORIDE - RMI3000487 - BATCH # 17004224 (QTY 50 GRMS)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"RECIPHARM AB","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"1095","totalValueFC":"55611.9","currency":"USD","unitRateINR":"92363.3","date":"30-May-2024","totalValueINR":"4618162.5","totalValueInUsd":"55611.9","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"3747702","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"Strada Statale dei Giovi, 131 20037Paderno Dugnano (MI)SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719513000,"product":"DEXMEDETOMIDINE HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"RECIPHARM AB","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"2205","totalValueFC":"223838.5","currency":"USD","unitRateINR":"185881.5","date":"28-Jun-2024","totalValueINR":"18588150","totalValueInUsd":"223838.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4232723","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA STATALE DEI GIOVI, 131, 20037 PADERNO DUGNANO(MI)-ITALYSDNF Italy","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"DEXMEDETOMIDINE HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"RECIPHARM AB","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"2205","totalValueFC":"223838.5","currency":"USD","unitRateINR":"185881.5","date":"12-Jul-2024","totalValueINR":"18588150","totalValueInUsd":"223838.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4462192","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA STATALE DEI GIOVI, 131, 20037 PADERNO DUGNANO(MI)-ITALYSDNF Italy","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"DEXMEDETOMIDINE HYDROCHLORIDE (QTY: 1 X 200MG, VALUE USD: 273) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"USP","supplierCountry":"JAPAN","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1365000","totalValueFC":"294.2","currency":"USD","unitRateINR":"122153800","date":"26-Aug-2024","totalValueINR":"24430.76","totalValueInUsd":"294.2","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"5258202","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD 21704 USA Frederick, , United States United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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