Find Dexmedetomidine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Related ProductsRelated Products

Synopsis

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

GLOBAL SALES INFORMATION

Regulatory FDF Prices

NA

MARKET PLACE

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
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 Weight 236.74 g/mol
Molecular Formula C13H17ClN2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count1
Rotatable Bond Count2
Exact Mass236.1080262 g/mol
Monoisotopic Mass236.1080262 g/mol
Topological Polar Surface Area28.7 Ų
Heavy Atom Count16
Formal Charge0
Complexity205
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameDexmedetomidine hydrochloride
PubMed HealthDexmedetomidine (Injection)
Drug ClassesAnalgesic, Anesthetic Adjunct, Sedative
Drug LabelDexmedetomidine 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 IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market StatusTentative Approval; Prescription
CompanyPar Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

2 of 4  
Drug NamePrecedex
Drug LabelPrecedex (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 IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market StatusPrescription
CompanyHospira

3 of 4  
Drug NameDexmedetomidine hydrochloride
PubMed HealthDexmedetomidine (Injection)
Drug ClassesAnalgesic, Anesthetic Adjunct, Sedative
Drug LabelDexmedetomidine 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 IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market StatusTentative Approval; Prescription
CompanyPar Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

4 of 4  
Drug NamePrecedex
Drug LabelPrecedex (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 IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market StatusPrescription
CompanyHospira

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

read-more
read-more

01

Fermion Oy

Finland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF arrow-down ASMF, BR... arrow-down AUDIT
fermion

02

Lifecare Laboratories Pvt Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
LifeCare Laboratories

03

ChemWerth Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Chemwerth Compnay Banner

04

Transo-Pharm USA LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

Flag U.S.A
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF US arrow-down AUDIT
Transo Pharm USA Company Banner

05

Transo-Pharm Handels GmbH

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTranso-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

Flag Germany
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Transo Pharm Handels GmbH

06

Moehs Iberica

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF arrow-down VMF Others AUDIT arrow-down
Moehs Iberica

07

Norchim

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
Norchim

08

Shandong Chenghui Shuangda Pharmac...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
Shandong Chenghui Shuangda Pharmaceutical

09

Deccan Nutraceuticals Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDeccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Deccan Nutraceuticals

10

Supriya Lifescience

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT arrow-down
Supriya
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

read-more
read-moreread-more

01

Fermion Oy

Finland
arrow
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

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

fermion

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-27

Pay. Date : 2012-12-17

DMF Number : 24202

Submission : 2011-12-15

Status : Active

Type : II

Chemwerth Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-21

Pay. Date : 2018-12-11

DMF Number : 33404

Submission : 2018-12-03

Status : Active

Type : II

Moehs Iberica

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2022-09-08

Pay. Date : 2022-01-27

DMF Number : 36478

Submission : 2022-01-10

Status : Active

Type : II

Moehs Iberica

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

Flag India
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38761

Submission : 2023-08-30

Status : Active

Type : II

Company Banner

06

AOCS Annual Meeting
Not Confirmed

06

AOCS Annual Meeting
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-09

Pay. Date : 2012-12-24

DMF Number : 22681

Submission : 2009-03-31

Status : Active

Type : II

blank

07

AOCS Annual Meeting
Not Confirmed

07

AOCS Annual Meeting
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-19

Pay. Date : 2012-12-19

DMF Number : 26223

Submission : 2012-07-16

Status : Active

Type : II

blank

08

Gland Pharma Ltd

India

USDMF

arrow
AOCS Annual Meeting
Not Confirmed

08

AOCS Annual Meeting
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23232

Submission : 2009-10-30

Status : Active

Type : II

blank

09

AOCS Annual Meeting
Not Confirmed

09

AOCS Annual Meeting
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23132

Submission : 2009-09-28

Status : Inactive

Type : II

blank

10

Cygnus Therapeutic Systems

Country

USDMF

arrow
AOCS Annual Meeting
Not Confirmed

10

Cygnus Therapeutic Systems

Country
arrow
AOCS Annual Meeting
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9303

Submission : 1991-08-23

Status : Inactive

Type : II

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

JDMF

read-more
read-moreread-more

01

Fermion Oy

Finland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

Dexmedetomidine hydrochloride (for manufacturing purposes only)

Registration Number : 218MF10833

Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland

Initial Date of Registration : 2006-10-20

Latest Date of Registration : 2021-07-01

fermion

02

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registration Number : 228MF10234

Registrant's Address : 53 Krustpils Street, Riga, Latvia

Initial Date of Registration : 2016-12-26

Latest Date of Registration : 2016-12-26

blank

03

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Registration Number : 303MF10179

Registrant's Address : 53 Krustpils Street, Riga, Latvia

Initial Date of Registration : 2021-12-15

Latest Date of Registration : 2021-12-15

blank

04

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride “Hengrui”

Registration Number : 228MF10029

Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jia...

Initial Date of Registration : 2016-02-02

Latest Date of Registration : 2022-07-06

blank

05

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride "Tateyama"

Registration Number : 229MF10055

Registrant's Address : 1133 Ōe, Imizu City, Toyama Prefecture

Initial Date of Registration : 2017-02-28

Latest Date of Registration : 2017-02-28

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EU WC

read-more
read-moreread-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.

Flag India
Digital Content Digital Content

Dexmedetomidine Hydrochloride USP

Date of Issue : 2023-02-08

Valid Till : 2026-02-07

Written Confirmation Number : WC-0548

Address of the Firm : 102, Doyen Chambers, Behind Saradhi Studio, Yousufguda Road, Ameerpet Hyderabad ...

LifeCare Laboratories

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

Flag India
Digital Content Digital Content

Dexmedetomidine HCl

Date of Issue : 2024-02-12

Valid Till : 2027-02-11

Written Confirmation Number : WC-0407

Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...

Company Banner

03

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride USP

Date of Issue : 2022-04-08

Valid Till : 2025-04-03

Written Confirmation Number : WC-0427

Address of the Firm : Plot No.49 & 50, J.N. Pharma City, Parawada (M), Visakhapatanam

blank

04

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride USP

Date of Issue : 2026-01-19

Valid Till : 2028-12-09

Written Confirmation Number : WC-0174

Address of the Firm : Plot No.8,7,6,20 & 24, MIDC Industrial Area, Post Kulgaon, Badlapur, Dist. Thane...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

read-more
read-moreread-more

01

Fermion Oy

Finland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

Dexmedetomidine hydrochloride

Registrant Name : Pfizer Korea

Registration Date : 2010-05-27

Registration Number : Su5382-1-ND

Manufacturer Name : Fermion Oy

Manufacturer Address : Laaketehtaantie 2. FIN-90660 Oulu_x000D_

fermion

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content

Dexmedetomidine hydrochloride

Registrant Name : Wooshin Labotach Co., Ltd.

Registration Date : 2025-09-29

Registration Number : Su579-6-ND

Manufacturer Name : MOEHS IBÉRICA, SL MGRC

Manufacturer Address : Poligono Industrial Rubí Sur C/ César Martinell i Brunet, 1008191 Rubí (Barcelona)...

Moehs Iberica

03

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2026-03-18

Registration Number : Su69-30-ND

Manufacturer Name : Emcure Pharmaceuticals Limit...

Manufacturer Address : Plot No. D-24 & D-24/1, MIDC, Kurkumbh Tal.: Daund, Dist.: Pune, 413 802, Maharashtra...

blank

04

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Fresenius Kabi Korea Co., Ltd.

Registration Date : 2021-03-12

Registration Number : Su181-5-ND

Manufacturer Name : Gland Pharm Limited

Manufacturer Address : Sy.No.143 to 148, 150 & 151, Near Gandimaisamma Cross Roads, DP Pally, Dundigal post,...

blank

05

Grindeks AS

Latvia
Arvo
Not Confirmed
arrow

Grindeks AS

Latvia
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-04-03

Registration Number : Su55-5-ND(1)

Manufacturer Name : Joint Stock Company "Grindek...

Manufacturer Address : 53, Krustpils Street, Riga, LV 1057, Latvia

blank

06

Grindeks AS

Latvia
Arvo
Not Confirmed
arrow

Grindeks AS

Latvia
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : MPK Korea Co., Ltd.

Registration Date : 2017-09-29

Registration Number : Su55-5-ND

Manufacturer Name : Joint Stock Company "Grindek...

Manufacturer Address : 53, Krustpils Street, Riga, LV 1057, Latvia

blank

07

Grindeks AS

Latvia
Arvo
Not Confirmed
arrow

Grindeks AS

Latvia
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Pamire Co., Ltd.

Registration Date : 2022-12-20

Registration Number : Su 55-5-ND(A)

Manufacturer Name : Joint Stock Company "Grindek...

Manufacturer Address : 53, Krustpils Street, Riga, LV 1057, Latvia

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Toru Co., Ltd.

Registration Date : 2021-01-13

Registration Number : Number 6580-24-ND(3)

Manufacturer Name : Jiangsu Hengrui Pharmaceutic...

Manufacturer Address : No. 22, Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone...

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : Penmix Co., Ltd.

Registration Date : 2016-10-27

Registration Number : Number 6580-24-ND(1)

Manufacturer Name : Jiangsu Hengrui Pharmaceutic...

Manufacturer Address : No. 22, Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone...

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine hydrochloride

Registrant Name : JW Life Science Co., Ltd.

Registration Date : 2020-05-27

Registration Number : Su295-2-ND

Manufacturer Name : Strem Chemical, Inc

Manufacturer Address : 7 Mulliken Way, Newburyport, MA 01950, USA

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

read-more
read-moreread-more

01

Fermion Oy

Finland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 12780-4640

Start Marketing Date : 1998-10-30

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

fermion

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 81912-0001

Start Marketing Date : 2021-07-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Moehs Iberica

03

NORCHIM

France

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 56087-0001

Start Marketing Date : 2019-01-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

Norchim

04

NORCHIM

France

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 56087-0002

Start Marketing Date : 2019-01-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

Norchim

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 61281-9800

Start Marketing Date : 2023-12-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Supriya

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

Flag India
Digital Content Digital Content

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 70600-046

Start Marketing Date : 2023-08-14

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Company Banner

07

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 72015-001

Start Marketing Date : 2018-01-23

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 33656-0020

Start Marketing Date : 2025-02-12

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

MEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 40074-0006

Start Marketing Date : 2019-12-27

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

NDC Package Code : 57884-0024

Start Marketing Date : 2012-09-04

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (0.4kg/.4kg)

Marketing Category : BULK INGREDIENT

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

VMF

read-more
read-moreread-more

01

Fermion Oy

Finland
arrow
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

VMF Number : 5721

Submission : 2001-05-21

Status : Active

Type : II

fermion

02

Fermion Oy

Finland
arrow
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

VMF Number : 5150

Submission : 1987-02-13

Status : Active

Type : II

fermion
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

Fermion Oy

Finland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

Flag Finland
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio inc...

Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio includes over 30 generic APIs and more than 10 NCEs, with two manufacturing sites and R&D facilities in Finland. Fermion has expanded capabilities in HPAPI production. Drug product CMO services cover hormonal and non-hormonal semi-solids, cytotoxic oral solids, and packaging, supported by three manufacturing sites and one packaging center under Orion. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
fermion

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.

Flag India
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting cu...

Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting customer requirements and building long-term partnerships. With state-of-the-art manufacturing facilities and dedicated production units, Lifecare Labs emphasizes quality, operational excellence, and responsible business practices, serving pharmaceutical markets with a commitment to reliability and sustainability. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LifeCare Laboratories

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Flag U.S.A
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...

ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships for product development, compliance, and secure logistics. ChemWerth accesses over 500 APIs and 30 manufacturing facilities across the US, Europe, India, and China, acts as a regulatory agent for 25+ FDA-approved facilities, sells 100+ products, and operates in 38 countries. In 2020, it filed its 500th DMF with the FDA . Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Chemwerth Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

Flag U.S.A
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...

Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and acts as a sourcing and regulatory marketing agent for API manufacturers. Transo-Pharm assists with DMF setup, GMP consulting, and regulatory activities, supported by a regulatory team, warehouse facilities, proprietary API process IPs, and laboratory partnerships, with offices in Shanghai, Hong Kong, Singapore, and the US. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Transo Pharm USA Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTranso-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

Flag Germany
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...

Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API lifecycle, from development to sales, offering diverse products and qualifying manufacturers for compliance. Acting as a sourcing and regulatory marketing agent, Transo-Pharm has offices in Shanghai, Hong Kong, Singapore, the United States, and an affiliated office in Mumbai. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Transo Pharm Handels GmbH

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Flag Spain
Digital Content Digital Content

Dexmedetomidine HCl

About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...

Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical, veterinary, agrochemical, nutraceutical, cosmetic, and fine chemical products. Our facilities meet the highest standards, including GMP, ICH, FDA, and TGA approvals, ensuring reliable and safe manufacturing. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only.
Moehs Iberica

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

Flag China
Digital Content Digital Content

Dexmedetomidine HCl

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished Formulation Technology Transfer. With 24 years' expertise, our 6 GMP workshops ensure 100-ton monthly cGMP-compliant capacity. We hold 21 NMPA-registered APIs, 4 US-DMF filings, 8 CEP applications, and passed US FDA, Korea MFDS, and global client audits. Note: Patent-protected products are for R&D use only per Patent Act, not for commercial sale.
Shandong Chenghui Shuangda Pharmaceutical

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDeccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

Flag India
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...

Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their commitment to quality and adherence to CGMP are integral to their operations. The company has been successfully audited by USFDA (5 times) and EDQM (2 times). The company manufactures high quality phytochemicals, semi-synthetic and synthetic APIs. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Deccan Nutraceuticals

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...

Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its facilities in Lote and Ambernath are approved by USFDA, EUGMP, Health Canada, and other agencies. Specializing in antihistamines, antiallergics, vitamins, anesthetics, and anti-asthmatics, Supriya serves 1500+ customers in over 86 countries, with 15+ USDMFs, 10+ CEPs, and a 1050 KL manufacturing capacity. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Supriya

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

Flag India
Digital Content Digital Content

Dexmedetomidine Hydrochloride

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Company Banner
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more

Details:

Dexmedetomidine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 23, 2019

Fermion Orion Company Banner

01

Details : Dexmedetomidine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 23, 2019

Fermion Orion Company Banner

Details:

Dr. Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Neurology Brand Name: Dexmedetomidine Hydrochloride-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 25, 2020

Dr Reddy Company Banner

02

Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Dr. Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively.

Product Name : Dexmedetomidine Hydrochloride-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 25, 2020

Dr Reddy Company Banner

Details:

Dexmedetomidine HCl is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of stress disorders, traumatic, acute.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: U.S. Department of War

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 08, 2026

blank

03

AOCS Annual Meeting
Not Confirmed
AOCS Annual Meeting
Not Confirmed

Details : Dexmedetomidine HCl is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of stress disorders, traumatic, acute.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 08, 2026

blank

Details:

Dexmedetomidine is a small molecule drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of alzheimer disease.


Lead Product(s): Dexmedetomidine Hydrochloride,Midodrine

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Stanford University | Washington State University

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 25, 2026

blank

04

AOCS Annual Meeting
Not Confirmed
AOCS Annual Meeting
Not Confirmed

Details : Dexmedetomidine is a small molecule drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of alzheimer disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 25, 2026

blank
  • Development Update

Details:

Dexmedetomidine HCl is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of breast neoplasms.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Shanghai Hengrui Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 20, 2026

blank

05

Tianjin Medical University Cancer Institute and Hospital

Country
arrow
AOCS Annual Meeting
Not Confirmed

Tianjin Medical University Cancer Institute and Hospital

Country
arrow
AOCS Annual Meeting
Not Confirmed

Details : Dexmedetomidine HCl is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of breast neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 20, 2026

blank
  • Development Update

Details:

Dexmedetomidine is a small molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Sleep Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Miscellaneous

Sponsor: Inner Mongolia Autonomous Region Mental Health Center

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 28, 2025

blank

06

Beijing Tiantan Hospital

Country
arrow
AOCS Annual Meeting
Not Confirmed

Beijing Tiantan Hospital

Country
arrow
AOCS Annual Meeting
Not Confirmed

Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area : Sleep

Highest Development Status : Undisclosed

Partner/Sponsor/Collaborator : Inner Mongolia Autonomous Region Mental Health Center

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Dexmedetomidine is a small molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 28, 2025

blank
  • Development Update

Details:

Dexmedetomidine HCl is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pharyngitis.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 02, 2025

blank

07

Prince Sultan Military Medical City

Country
arrow
AOCS Annual Meeting
Not Confirmed

Prince Sultan Military Medical City

Country
arrow
AOCS Annual Meeting
Not Confirmed

Details : Dexmedetomidine HCl is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pharyngitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 02, 2025

blank

Details:

Dexmedetomidine HCl is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Sedation.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 11, 2025

blank

08

AOCS Annual Meeting
Not Confirmed
AOCS Annual Meeting
Not Confirmed

Details : Dexmedetomidine HCl is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Sedation.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 11, 2025

blank

Details:

Strengthened cash position will support advancement of SERENITY trial, to evaluate BXCL501, an ODT of dexmedetomidine, for agitation associated with bipolar disorders or schizophrenia.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Igalmi

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: $14.0 million Upfront Cash: Undisclosed

Deal Type: Financing March 11, 2025

blank

09

AOCS Annual Meeting
Not Confirmed
AOCS Annual Meeting
Not Confirmed

Details : Strengthened cash position will support advancement of SERENITY trial, to evaluate BXCL501, an ODT of dexmedetomidine, for agitation associated with bipolar disorders or schizophrenia.

Product Name : Igalmi

Product Type : Miscellaneous

Upfront Cash : Undisclosed

March 11, 2025

blank

Details:

An orally dissolving film formulation of BXCL501 (dexmedetomidine), in the at-home setting is being investigated for acute treatment of agitation associated with bipolar disorders or schizophrenia.


Lead Product(s): Dexmedetomidine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Igalmi

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 07, 2025

blank

10

AOCS Annual Meeting
Not Confirmed
AOCS Annual Meeting
Not Confirmed

Details : An orally dissolving film formulation of BXCL501 (dexmedetomidine), in the at-home setting is being investigated for acute treatment of agitation associated with bipolar disorders or schizophrenia.

Product Name : Igalmi

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 07, 2025

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

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

02

Dexmedetomidine Hydrochloride

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 17-09-2018

Application Number : 111718004

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

03

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 10-11-2011

Application Number : 11718006

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

04

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 10-11-2011

Application Number : 11718002

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

05

Medetomidine Hydrochloride

Brand Name : Domitor Vet.

Dosage Form : Injection Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 05-05-1987

Application Number : 28101276086

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

06

Dexmedetomidin

Brand Name : Dexdomitor

Dosage Form : Injection Solution

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 30-08-2012

Application Number : 28105039811

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

07

Dexmedetomidin

Brand Name : Sileo

Dosage Form : Oral Hygiene

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 10-06-2015

Application Number : 28105336613

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

08

Dexmedetomidin

Brand Name : Dexdomitor

Dosage Form : Injection Solution

Dosage Strength : 0.5mg/ml

Packaging :

Approval Date : 30-08-2002

Application Number : 28103261101

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

09

Dexmedetomidin

Brand Name : Dexdor

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 16-09-2011

Application Number : 28104789810

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

10

Dexmedetomidinhydroklorid

Brand Name : Dexdor

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 16-09-2011

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AP

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date : 2026-02-25

Application Number : 220315

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AP

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date : 2026-02-25

Application Number : 220315

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

03

AMNEAL

U.S.A
Arvo
Not Confirmed
arrow

AMNEAL

U.S.A
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date : 2023-05-15

Application Number : 216604

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

blank

04

AMNEAL

U.S.A
Arvo
Not Confirmed
arrow

AMNEAL

U.S.A
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date : 2023-05-15

Application Number : 216604

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

blank

05

CAPLIN

India
Arvo
Not Confirmed
arrow

CAPLIN

India
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date : 2016-06-14

Application Number : 91465

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

blank

06

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date : 2015-09-18

Application Number : 201072

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

blank

07

HOSPIRA

U.S.A
Arvo
Not Confirmed
arrow

HOSPIRA

U.S.A
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Approval Date : 2020-01-31

Application Number : 21038

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

Approval Date : 2015-10-21

Application Number : 206628

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

Approval Date : 2015-10-21

Application Number : 206628

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date : 2017-09-19

Application Number : 209065

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

read-more
read-more

01

Dexmedetomidine Hydrochloride

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 17-09-2018

Application Number : 111718004

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

02

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 10-11-2011

Application Number : 11718006

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

03

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 10-11-2011

Application Number : 11718002

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

04

Medetomidine Hydrochloride

Brand Name : Domitor Vet.

Dosage Form : Injection Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 05-05-1987

Application Number : 28101276086

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

05

Dexmedetomidin

Brand Name : Dexdomitor

Dosage Form : Injection Solution

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 30-08-2012

Application Number : 28105039811

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

06

Dexmedetomidin

Brand Name : Sileo

Dosage Form : Oral Hygiene

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 10-06-2015

Application Number : 28105336613

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

07

Dexmedetomidin

Brand Name : Dexdomitor

Dosage Form : Injection Solution

Dosage Strength : 0.5mg/ml

Packaging :

Approval Date : 30-08-2002

Application Number : 28103261101

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

08

Dexmedetomidin

Brand Name : Dexdor

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 16-09-2011

Application Number : 28104789810

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

09

Dexmedetomidinhydroklorid

Brand Name : Dexdor

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 16-09-2011

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

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

Flag Austria
Digital Content Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Deksmedetomidinhydroklorid

Brand Name : Dexmedetomidine Ever Pharma

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Ever Pharma CB
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Canada

read-more
read-more

01

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

02

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : SILEO

Dosage Form : GEL

Dosage Strength : 0.1MG/ML

Packaging :

Approval Date :

Application Number : 2530392

Regulatory Info : PRESCRIPTION

Registration Country : Canada

Fermion Orion Company Banner

03

ACCORD HEALTHCARE INC

United Kingdom
Arvo
Not Confirmed
arrow

ACCORD HEALTHCARE INC

United Kingdom
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION

Dosage Form : SOLUTION

Dosage Strength : 100MCG/ML

Packaging : 2ML

Approval Date :

Application Number : 2477327

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

04

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION

Dosage Form : SOLUTION

Dosage Strength : 100MCG/ML

Packaging : 25X2ML

Approval Date :

Application Number : 2464381

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

05

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXMEDESED

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number : 2524945

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

06

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

MEDETOMIDINE HYDROCHLORIDE

Brand Name : ZENALPHA

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number : 2537648

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

07

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION

Dosage Form : SOLUTION

Dosage Strength : 100MCG/ML

Packaging :

Approval Date :

Application Number : 2528886

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : SEDAJECT

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number : 2492431

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE INJECTION

Dosage Form : SOLUTION

Dosage Strength : 400MCG/100ML

Packaging :

Approval Date :

Application Number : 2487373

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXVETIDINE

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number : 2483947

Regulatory Info : PRESCRIPTION

Registration Country : Canada

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

South Africa

read-more
read-more

01

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

02

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Sedalpha 100 µg/ml

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

03

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine

Brand Name : Precia

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

04

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Sedmedex 100 µg/ml

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

05

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine hydrochloride

Brand Name : Precedex

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

blank

06

Pharmacorp (Pty) Ltd

South Africa
AOCS Annual Meeting
Not Confirmed
arrow

Pharmacorp (Pty) Ltd

South Africa
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine HCl

Brand Name : TOMEXA 200 μg/2 ml

Dosage Form : INJ

Dosage Strength : 100μg/ml

Packaging : 2X5μg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

07

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE

Brand Name : DEXISUN

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

08

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEMETEV

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank

09

AOCS Annual Meeting
Not Confirmed
arrow
arrow
AOCS Annual Meeting
Not Confirmed

Dexmedetomidine hydrochloride

Brand Name : Demodinex

Dosage Form : INJ

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Dossiers

read-more
read-more

01

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content 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

Ethypharm

01

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content Digital Content

Packaging :

Regulatory Info :

Dexmedetomidine Hydrochloride

Dosage : Solution for Infusion

Dosage Strength : 4MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : France

Ethypharm

02

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content 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

Ethypharm

02

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content Digital Content

Packaging :

Regulatory Info :

Dexmedetomidine Hydrochloride

Dosage : Vial

Dosage Strength : 100MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : France

Ethypharm

03

Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

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

Flag Austria
Digital Content Digital Content

Regulatory Info :

Registration Country : Austria

Dexmedetomidine

Brand Name :

Dosage Form : Concentrate for Soluti...

Dosage Strength : 100MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Ever Pharma CB

03

Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

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

Flag Austria
Digital Content Digital Content

Packaging :

Regulatory Info :

Dexmedetomidine

Dosage : Concentrate for Soluti...

Dosage Strength : 100MCG

Brand Name :

Approval Date :

Application Number :

Registration Country : Austria

Ever Pharma CB

04

Cuckos

India
Arvo
Not Confirmed
arrow

Cuckos

India
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Dexmedetomidine

Dosage Form : Injection

Dosage Strength : 0.5MG/ML

Packaging : 10 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

04

Cuckos

India
Arvo
Not Confirmed
arrow

Cuckos

India
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Injection

Dosage Strength : 0.5MG/ML

Brand Name : Dexmedetomidine

Approval Date :

Application Number :

Registration Country : India

blank

05

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine

Brand Name : Aro-midin

Dosage Form : Injection

Dosage Strength : 200MCG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

blank

05

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine

Dosage : Injection

Dosage Strength : 200MCG/2ML

Brand Name : Aro-midin

Approval Date :

Application Number :

Registration Country : Iran

blank

06

Dong Bang Co., Ltd

South Korea
Arvo
Not Confirmed
arrow

Dong Bang Co., Ltd

South Korea
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Medetin

Dosage Form : Injectable

Dosage Strength : 1MG/ML

Packaging : 10ML Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

blank

06

Dong Bang Co., Ltd

South Korea
Arvo
Not Confirmed
arrow

Dong Bang Co., Ltd

South Korea
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Injectable

Dosage Strength : 1MG/ML

Brand Name : Medetin

Approval Date :

Application Number :

Registration Country : South Korea

blank

07

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 200MCG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : US ANDA- Submitted

Registration Country : China

blank

07

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Injection

Dosage Strength : 200MCG/2ML

Brand Name :

Approval Date :

Application Number :

Registration Country : China

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Dexmedetomidine Hydroc...

Dosage Form : Liquid Injection

Dosage Strength : 100MCG/ML

Packaging : 2 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

08

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Liquid Injection

Dosage Strength : 100MCG/ML

Brand Name : Dexmedetomidine Hydroc...

Approval Date :

Application Number :

Registration Country : India

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Dexem 0.5

Dosage Form : Injection

Dosage Strength : 100MCG/ML

Packaging : 1x0.5

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Injection

Dosage Strength : 100MCG/ML

Brand Name : Dexem 0.5

Approval Date :

Application Number :

Registration Country : India

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : Dexem 2

Dosage Form : Injection

Dosage Strength : 100MCG/ML

Packaging : 1x2

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

10

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Dosage : Injection

Dosage Strength : 100MCG/ML

Brand Name : Dexem 2

Approval Date :

Application Number :

Registration Country : India

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

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

USFDA APPLICATION NUMBER - 206628

read-more

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

USFDA APPLICATION NUMBER - 206628

read-more

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

USFDA APPLICATION NUMBER - 206628

read-more

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

USFDA APPLICATION NUMBER - 206628

read-more

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

USFDA APPLICATION NUMBER - 21038

read-more

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

USFDA APPLICATION NUMBER - 21038

read-more

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

USFDA APPLICATION NUMBER - 21038

read-more

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

USFDA APPLICATION NUMBER - 21038

read-more

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

USFDA APPLICATION NUMBER - 21038

read-more

Related Excipient Companies

Upload your portfolio for free, ask us

Excipients by Applications

Click here to find the perfect excipient manufacturers by their capabilities

Parenteral

read-more
read-more

01

Kirsch Pharma

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHigh-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.

Grade : Biopharma Grade

Category : Parenteral

Brand Name : Sodium Chloride

Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.

Pharmacopoeia Ref : On Request

Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...

arrow

02

Kirsch Pharma

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHigh-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.

Grade : Biopharma Grade

Category : Parenteral

Brand Name : Sodium Acetate

Excipient Details : Used as a buffering agent in cell culture media, purification processes and injectable formulations.

Pharmacopoeia Ref : On Request

Technical Specs : Technical specification will be discussed after enquiry. Customis...

arrow

API Stability Enhancers

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.

Grade : Oral

Category : API Stability Enhancers

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.

Grade : Oral

Category : API Stability Enhancers

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more
DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 4280

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

NEWS #PharmaBuzz

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

US Medicaid Prescriptions

read-more
read-more

01

arrow
AOCS Annual Meeting
Not Confirmed
arrow
AOCS Annual Meeting
Not Confirmed

Company : Bioxcel Therape

Dexmedetomidine HCl

Drug Cost (USD) : 64,689

Year : 2023

Prescribers : 15

Prescriptions : 24

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Market Place

Do you need sourcing support? Ask us

APIs

read-more
read-more
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF DOSSIERS

read-more
read-more
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

read-more
read-more

01

arrow
AOCS Annual Meeting
Not Confirmed

BIOXCEL

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 11478422

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215390

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-26

blank

02

arrow
AOCS Annual Meeting
Not Confirmed

BIOXCEL

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 11497711

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215390

Patent Use Code : U-3645

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-26

blank

03

arrow
AOCS Annual Meeting
Not Confirmed

BIOXCEL

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 12109196

Drug Substance Claim :

Drug Product Claim :

Application Number : 215390

Patent Use Code : U-3935

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-07-17

blank

04

arrow
AOCS Annual Meeting
Not Confirmed

BIOXCEL

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 11497711

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215390

Patent Use Code : U-3645

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-26

blank

05

arrow
AOCS Annual Meeting
Not Confirmed

BIOXCEL

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 12109196

Drug Substance Claim :

Drug Product Claim :

Application Number : 215390

Patent Use Code : U-3935

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-07-17

blank

06

arrow
AOCS Annual Meeting
Not Confirmed

HOSPIRA

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 9616049*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 21038

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-07-04

blank

07

arrow
AOCS Annual Meeting
Not Confirmed

HOSPIRA

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 8242158

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21038

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-01-04

blank

08

arrow
AOCS Annual Meeting
Not Confirmed

HOSPIRA

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 9320712*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 21038

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-07-04

blank

09

arrow
AOCS Annual Meeting
Not Confirmed

HOSPIRA

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 9616049*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 21038

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-07-04

blank

10

arrow
AOCS Annual Meeting
Not Confirmed

HOSPIRA

U.S.A
arrow
AOCS Annual Meeting
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

US Patent Number : 8455527*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 21038

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-07-04

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Health Canada Patents

read-more
read-more

01

arrow
Arvo
Not Confirmed
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : PRECEDEX

Patent Number : 2326339

Filing Date : 1999-03-31

Strength per Unit : 100 mcg / mL

Dosage Form : Solution

Human Or VET : Human

Route of Administration : Intravenous

Patent Expiration Date : 2019-03-31

Date Granted : 2008-12-23

blank

02

arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : PRECEDEX

Patent Number : 1337659

Filing Date : 1988-07-14

Strength per Unit : 100 mcg / mL

Dosage Form : Solution

Human Or VET : Human

Route of Administration : Intravenous

Patent Expiration Date : 2012-11-28

Date Granted : 1995-11-28

blank

03

arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride

Brand Name : DEXDOMITOR

Patent Number : 1337659

Filing Date : 1988-07-14

Strength per Unit : 0.5 mg / mL

Dosage Form : Sterile injectable solution

Human Or VET : Veterinary

Route of Administration : im - dogs, cats, iv - dogs

Patent Expiration Date : 2012-11-28

Date Granted : 1995-11-28

blank

04

Pfizer Canada ULC

arrow
Arvo
Not Confirmed

Pfizer Canada ULC

Country
arrow
Arvo
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Patent Number : 2851780

Filing Date : 2012-09-27

Strength per Unit : 4 mcg / ml

Dosage Form : SOLUTION

Human Or VET : Human

Route of Administration : INTRAVENOUS

Patent Expiration Date : 2032-09-27

Date Granted : 2017-11-28

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

REF. STANDARDS & IMPURITIES

Upload your portfolio for free, ask us

Others

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.

Flag U.S.A
Digital Content Digital Content

Dexmedetomidine Hydrochloride

CAS Number :

Quantity Per Vial :

Sale Unit :

Price : $310.00

Details :

Monograph : PHR2701-500MG

Storage : +2°C to +30°C

Code/Batch No :

Company Banner

02

XYZ Pharma

Country
arrow
Arvo
Not Confirmed

XYZ Pharma

Country
arrow
Arvo
Not Confirmed

Dexmedetomidine Hydrochloride (200 mg)

CAS Number : 145108-58-3

Quantity Per Vial : 200

Sale Unit : mg

Price : $245.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1179333 / R14110

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 145108-58-3 / Dexmedetomidine Hydrochloride API manufacturers, exporters & distributors?

Dexmedetomidine Hydrochloride manufacturers, exporters & distributors 1

85

PharmaCompass offers a list of Dexmedetomidine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier.

API | Excipient name

Dexmedetomidine Hydrochloride

Synonyms

145108-58-3, Dexmedetomidine hcl, Precedex, Dexdomitor, Dexdor, Sileo

Cas Number

145108-58-3

Unique Ingredient Identifier (UNII)

1018WH7F9I

About 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.

Medetomidine HCl Manufacturers

A Medetomidine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medetomidine HCl, including repackagers and relabelers. The FDA regulates Medetomidine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medetomidine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Medetomidine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

Medetomidine HCl Suppliers

A Medetomidine HCl supplier is an individual or a company that provides Medetomidine HCl active pharmaceutical ingredient (API) or Medetomidine HCl finished formulations upon request. The Medetomidine HCl suppliers may include Medetomidine HCl API manufacturers, exporters, distributors and traders.

click here to find a list of Medetomidine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Medetomidine HCl USDMF

A Medetomidine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Medetomidine HCl active pharmaceutical ingredient (API) in detail. Different forms of Medetomidine HCl DMFs exist exist since differing nations have different regulations, such as Medetomidine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Medetomidine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Medetomidine HCl USDMF includes data on Medetomidine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medetomidine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Medetomidine HCl suppliers with USDMF on PharmaCompass.

Medetomidine HCl JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Medetomidine HCl Drug Master File in Japan (Medetomidine HCl JDMF) empowers Medetomidine HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Medetomidine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Medetomidine HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Medetomidine HCl suppliers with JDMF on PharmaCompass.

Medetomidine HCl KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Medetomidine HCl Drug Master File in Korea (Medetomidine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medetomidine HCl. The MFDS reviews the Medetomidine HCl KDMF as part of the drug registration process and uses the information provided in the Medetomidine HCl KDMF to evaluate the safety and efficacy of the drug.

After submitting a Medetomidine HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Medetomidine HCl API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Medetomidine HCl suppliers with KDMF on PharmaCompass.

Medetomidine HCl WC

A Medetomidine HCl written confirmation (Medetomidine HCl WC) is an official document issued by a regulatory agency to a Medetomidine HCl manufacturer, verifying that the manufacturing facility of a Medetomidine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Medetomidine HCl APIs or Medetomidine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Medetomidine HCl WC (written confirmation) as part of the regulatory process.

click here to find a list of Medetomidine HCl suppliers with Written Confirmation (WC) on PharmaCompass.

Medetomidine HCl NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Medetomidine HCl as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Medetomidine HCl API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Medetomidine HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Medetomidine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medetomidine HCl NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Medetomidine HCl suppliers with NDC on PharmaCompass.

Medetomidine HCl GMP

Medetomidine HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Medetomidine HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Medetomidine HCl GMP manufacturer or Medetomidine HCl GMP API supplier for your needs.

Medetomidine HCl CoA

A Medetomidine HCl CoA (Certificate of Analysis) is a formal document that attests to Medetomidine HCl's compliance with Medetomidine HCl specifications and serves as a tool for batch-level quality control.

Medetomidine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Medetomidine HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Medetomidine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Medetomidine HCl EP), Medetomidine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medetomidine HCl USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty