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Medetomidine Hydrochloride

Fermion Dexmedetomidine HCl

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Moehs Dexmedetomidine Hydrochloride

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 18 USDMF, 5 JDMF, 5 EU WC, 13 KDMF, 18 NDC API, 8 VMF, 32 Listed Suppliers, $ API Reference Price

47 API Suppliers
18 USDMF
5 JDMF
5 EU WC
13 KDMF
18 NDC API
8 VMF
32 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers, 60 FDA Orange Book, 6 Europe, 15 Canada, 8 South Africa, 11 Listed Dossiers

100 FDF Dossiers
60 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, 53 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
53 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices, 4 Annual Reports

globalSalesInformation
4 Finished Drug Prices
4 Annual Reports

MARKET PLACE

19 APIs, 7 FDF Dossiers

marketPlace
19 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

66 US Patents, 9 US Exclusivities, 3 Health Canada Patents

patents
66 US Patents
9 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

47

API Suppliers

18

USDMF

0

CEP/COS

CEP/COS Certifications

5

JDMF

5

EU WC

13

KDMF

18

NDC API

8

VMF

32

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 892,458

MARKET PLACE

19

API

7

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

100

FDF Dossiers

60

FDA Orange Book

FDA (Orange Book)

6

Europe

15

Canada

0

Australia

8

South Africa

11

Listed Dossiers

40DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

1

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

66

US Patents

9

US Exclusivities

3

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

53

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

NA

Annual Reports (USD Million)

893

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

Dexmedetomidine Hydrochloride

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

QN05CM18

QN05CM18

QN05CM18

API SUPPLIERS

01

Fermion Oy

Finland

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Lifecare Laboratories Pvt Ltd

India

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Moehs Iberica

Spain

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ChemWerth Inc

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Transo-Pharm Handels GmbH

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Suanfarma

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Deccan Nutraceuticals Pvt. Ltd

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Supriya Lifescience

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USDMF

01

Fermion Oy

Finland

Bio-Europe 2024

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Digital Content

Dexmedetomidine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2021-08-31

Pay. Date : 2021-08-26

DMF Number : 13810

Submission : 1998-10-30

Status : Active

Type : II

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Moehs Iberica Sl

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DMF Review : Complete

Rev. Date : 2022-09-08

Pay. Date : 2022-01-27

DMF Number : 36478

Submission : 2022-01-10

Status : Active

Type : II

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Moehs Iberica Sl

Spain

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DMF Review : Complete

Rev. Date : 2019-03-21

Pay. Date : 2018-12-11

DMF Number : 33404

Submission : 2018-12-03

Status : Active

Type : II

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Chemwerth Inc

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Dexmedetomidine Hcl

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Submission : 2011-12-15

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Sterling Wisconsin Llc

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Asymchem Laboratories Tianjin Co Ltd

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Gland Pharma Ltd

India

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Jiangsu Hengrui Pharmaceuticals Co L...

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Reliable Biopharmaceutical Llc

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Cygnus Therapeutic Systems

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API Reference Price

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BOX 28,02101 FI ESP OO FINLAND FINLAND","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707330600,"product":"DEXMEDETOMIDINE HYDROCHLORIDE USP","address":"NO 28","city":"BOMBAY ,MAHARASHTRA","supplier":"M\/S GUANGZHOU CHEERLAND IMPORT EXPORT LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RUSKIN CHEMIPHARM","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"2","unit":"GMS","unitRateFc":"1450","totalValueFC":"2934.1","currency":"USD","unitRateINR":"121727.5","date":"08-Feb-2024","totalValueINR":"243455","totalValueInUsd":"2934.1","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"2055264","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM NO 703-2 363 DONG FENG ZHONG ROAD GUANGZHOU CHINASDNF China","customerAddress":"NO 28"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711132200,"product":"DEXMEDETOMIDINE HYDROCHLORIDE USP-NF 2023 (LICENCE NO- TL\/AZ\/21\/002189)(FOR R&D PURPOSE)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"4","unit":"GMS","unitRateFc":"1815","totalValueFC":"7322.4","currency":"USD","unitRateINR":"152006.3","date":"23-Mar-2024","totalValueINR":"608025","totalValueInUsd":"7322.4","indian_port":"Ahmedabad Air","hs_no":"29332990","bill_no":"2714911","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/.Roma, 8-12 NAU 08191 RUBI BarcelonaSDNF Spain","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714329000,"product":"DEXMEDETOMIDINE HYDROCHLORIDE USP (QTY- 132.5 GMS X 1400 USD\/GMS) (CAS NO:145108-58-3)ASPER INV","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"CHEMISTRY & HEALTH FZ-LLC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.13","actualQuantity":"0.1325","unit":"KGS","unitRateFc":"1400000","totalValueFC":"187483","currency":"USD","unitRateINR":"118160000","date":"29-Apr-2024","totalValueINR":"15656200","totalValueInUsd":"187483","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"3253316","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"P.O BOX 452820 DUBAI SCIENCE PARK DUBAI\/\/OFFICE EO 05 2ND FLOOR DSP LABORATORY COMPLEX DUBAI SCIENCE PARK United Arab Emirates","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715279400,"product":"DEXMEDETOMIDINE HYDROCHLORIDE","address":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB","city":"HYDERABAD,TELANGANA","supplier":"INTERQUIM SA","supplierCountry":"MEXICO","foreign_port":"N\/A","customer":"CRONUS PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.16","actualQuantity":"160","unit":"GMS","unitRateFc":"1500","totalValueFC":"242867.3","currency":"USD","unitRateINR":"126525","date":"10-May-2024","totalValueINR":"20244000","totalValueInUsd":"242867.3","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29332990","bill_no":"1003933","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"AV. ANTOINE LAVOISIER,NO. 22 PARQUE INDUSTRIAL CUAMATLA CUAUTITLAN IZCALLI,ESTADO DE MEEXICO,C.P.54730 MX","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"},{"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":"55404.1","currency":"USD","unitRateINR":"92363.3","date":"30-May-2024","totalValueINR":"4618162.5","totalValueInUsd":"55404.1","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":"222667.4","currency":"USD","unitRateINR":"185881.5","date":"28-Jun-2024","totalValueINR":"18588150","totalValueInUsd":"222667.4","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":1720636200,"product":"DEXMEDETOMIDINE HYDROCHLORIDE USP","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.009","unit":"KGS","unitRateFc":"1400000","totalValueFC":"13829.8","currency":"EUR","unitRateINR":"128450000","date":"11-Jul-2024","totalValueINR":"1156050","totalValueInUsd":"13829.8","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"4450497","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"KOIVU MANKKAAN TIE 6A P O BOX 28SDNFSDNF Finland","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"DEXMEDETOMIDINE HYDROCHLORIDE","address":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB","city":"HYDERABAD,TELANGANA","supplier":"INTERQUIM SA","supplierCountry":"MEXICO","foreign_port":"JUAREZ","customer":"CRONUS PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.16","actualQuantity":"160","unit":"GMS","unitRateFc":"1500","totalValueFC":"243003.6","currency":"USD","unitRateINR":"127275","date":"03-Sep-2024","totalValueINR":"20364000","totalValueInUsd":"243003.6","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29332990","bill_no":"5394899","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"JUAREZ","supplierAddress":"AV. ANTOINE LAVOISIER, No.22 PARQUE INDUSTRIAL CUAMATLA CUAUTITLAN SDNF Mexico","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"}]

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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Drugs in Development

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FDF Dossiers

01

Aspen Pharmacare Holdings

South Africa

SupplySide West 2024

Not Confirmed

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South Africa

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Regulatory Info : Generic

Registration Country : South Africa

Dexmedetomidine

Brand Name : Eccladex

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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02

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info :

Registration Country : Sweden

dexmedetomidine hydrochloride

Brand Name : Dexdor

Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION

Dosage Strength : 100 MICROGRAM / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

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03

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info :

Registration Country : Norway

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

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04

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info :

Registration Country : Norway

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

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05

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info :

Registration Country : Norway

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

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06

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info :

Registration Country : Norway

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

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Digital Content

Corporate PDF

07

Orion Corporation

Finland

SupplySide West 2024

Not Confirmed

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Finland

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXDOMITOR

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging : 10ML

Approval Date :

Application Number : 2333929

Regulatory Info : Prescription

Registration Country : Canada

Fermion Orion Company Banner

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08

Ethypharm

France

SupplySide West 2024

Not Confirmed

Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

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France

Digital Content

Regulatory Info :

Registration Country : France

Dexmedetomidine Hydrochloride

Brand Name :

Dosage Form : Solution for Infusion

Dosage Strength : 4MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Product Web Link

Digital Content

09

Ethypharm

France

SupplySide West 2024

Not Confirmed

Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

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France

Digital Content

Regulatory Info :

Registration Country : France

Dexmedetomidine Hydrochloride

Brand Name :

Dosage Form : Vial

Dosage Strength : 100MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Product Web Link

Digital Content

10

Ever Pharma

Austria

SupplySide West 2024

Not Confirmed

Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances & suspensions.

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Austria

Digital Content

Regulatory Info :

Registration Country : Austria

Dexmedetomidine

Brand Name :

Dosage Form : Concentrate for Solution for Infusion

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Product Web Link

Digital Content

Corporate PDF

Only 10 entries up to this point, click to access all

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FDA Orange Book

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Europe

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Canada

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

USFDA APPLICATION NUMBER - 206628

DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 206628

DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

USFDA APPLICATION NUMBER - 206628

DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 206628

DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/2...DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 21038

DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

USFDA APPLICATION NUMBER - 21038

DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 21038

DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 21038

DOSAGE - INJECTABLE;INJECTION - EQ 80MCG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

USFDA APPLICATION NUMBER - 21038

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Finished Drug Prices

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Annual Reports

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Patents & EXCLUSIVITIES

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US Patents

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