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1. Dexmedetomidine
2. Hydrochloride, Dexmedetomidine
3. Mpv 1440
4. Mpv-1440
5. Mpv1440
6. Precedex
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
| Molecular Weight | 236.74 g/mol |
|---|---|
| Molecular Formula | C13H17ClN2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 2 |
| Exact Mass | 236.1080262 g/mol |
| Monoisotopic Mass | 236.1080262 g/mol |
| Topological Polar Surface Area | 28.7 Ų |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 205 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Dexmedetomidine hydrochloride |
| PubMed Health | Dexmedetomidine (Injection) |
| Drug Classes | Analgesic, Anesthetic Adjunct, Sedative |
| Drug Label | Dexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[... |
| Active Ingredient | Dexmedetomidine hydrochloride |
| Dosage Form | Injectable |
| Route | injection; Injection |
| Strength | eq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg |
| Market Status | Tentative Approval; Prescription |
| Company | Par Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn |
| 2 of 4 | |
|---|---|
| Drug Name | Precedex |
| Drug Label | Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t... |
| Active Ingredient | Dexmedetomidine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml) |
| Market Status | Prescription |
| Company | Hospira |
| 3 of 4 | |
|---|---|
| Drug Name | Dexmedetomidine hydrochloride |
| PubMed Health | Dexmedetomidine (Injection) |
| Drug Classes | Analgesic, Anesthetic Adjunct, Sedative |
| Drug Label | Dexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[... |
| Active Ingredient | Dexmedetomidine hydrochloride |
| Dosage Form | Injectable |
| Route | injection; Injection |
| Strength | eq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg |
| Market Status | Tentative Approval; Prescription |
| Company | Par Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn |
| 4 of 4 | |
|---|---|
| Drug Name | Precedex |
| Drug Label | Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t... |
| Active Ingredient | Dexmedetomidine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml) |
| Market Status | Prescription |
| Company | Hospira |
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
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.)
N05CM18
QN05CM18
QN05CM18
QN05CM18
QN05CM18
VMF Number : 5150
Submission : 1987-02-13
Status : Active
Type : II
| Available Reg Filing : ASMF, BR, CN |
Date of Issue : 2023-02-08
Valid Till : 2026-02-07
Written Confirmation Number : WC-0548
Address of the Firm :
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-27
Pay. Date : 2012-12-17
DMF Number : 24202
Submission : 2011-12-15
Status : Active
Type : II
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-21
Pay. Date : 2018-12-11
DMF Number : 33404
Submission : 2018-12-03
Status : Active
Type : II
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
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), Spain
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
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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
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
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38761
Submission : 2023-08-30
Status : Active
Type : II
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

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

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23232
Submission : 2009-10-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23132
Submission : 2009-09-28
Status : Inactive
Type : II

USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9303
Submission : 1991-08-23
Status : Inactive
Type : II

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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

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

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 ...
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...
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

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...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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_
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)...
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...

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,...

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

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

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

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...

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...

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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
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
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
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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
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
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

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

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]VMF Number : 5721
Submission : 2001-05-21
Status : Active
Type : II
VMF Number : 5150
Submission : 1987-02-13
Status : Active
Type : II
VMF Number : 6420
Submission : 2021-04-13
Status : Active
Type : II

VMF Number : 6249
Submission : 2018-05-17
Status : Active
Type : II

VMF Number : 6428
Submission : 2021-05-05
Status : Active
Type : II

VMF Number : 6379
Submission : 2020-07-20
Status : Active
Type : II

VMF Number : 6348
Submission : 2019-11-01
Status : Active
Type : II

VMF Number : 6257
Submission : 2018-07-30
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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...
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...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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...
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 GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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...
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...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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 ...
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
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...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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...
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...
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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
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Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
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
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
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
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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

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Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : U.S. Department of War
Deal Size : Inapplicable
Deal Type : Inapplicable
BioXcel Enrolls First Patients in US War-Funded Study of BXCL501 for Acute Stress Reactions
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

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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

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Lead Product(s) : Dexmedetomidine Hydrochloride,Midodrine
Therapeutic Area : Neurology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Stanford University | Washington State University
Deal Size : Inapplicable
Deal Type : Inapplicable
Pharmacological Enhancement of Glymphatic Function in Humans
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

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

Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Shanghai Hengrui Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
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

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

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
Study on the Efficacy and Safety of Anesthesia-Induced Sleep Therapy for Refractory Insomnia
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

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

Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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

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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

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Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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

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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

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Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $14.0 million
Deal Type : Financing
BioXcel Strengthens Cash Position for SERENITY Phase 3 Agitation Trial
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

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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

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Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
BioXcel Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial
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

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Eccladex
Dosage Form : INF
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Approved
Registration Country : Sweden
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
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AP
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AP
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
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RLD : No
TE Code : AP
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

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RLD : No
TE Code : AP
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

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RLD : No
TE Code : AP
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

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RLD : No
TE Code : AP
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

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RLD : Yes
TE Code : AP
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

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RLD : Yes
TE Code : AP
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

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RLD : Yes
TE Code : AP
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

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RLD : No
TE Code : AP
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

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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Authorized
Registration Country : Spain
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Prescription
Registration Country : Denmark
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
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Regulatory Info : Approved
Registration Country : Sweden
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
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Marketed
Registration Country : Norway
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
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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : DEXDOMITOR
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging : 10ML
Approval Date :
Application Number : 2333929
Regulatory Info : PRESCRIPTION
Registration Country : Canada
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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : SILEO
Dosage Form : GEL
Dosage Strength : 0.1MG/ML
Packaging :
Approval Date :
Application Number : 2530392
Regulatory Info : PRESCRIPTION
Registration Country : Canada
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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : DEXMEDESED
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number : 2524945
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : ZENALPHA
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number : 2537648
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : SEDAJECT
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number : 2492431
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : DEXVETIDINE
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number : 2483947
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Eccladex
Dosage Form : INF
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Regulatory Info : Generic
Registration Country : South Africa
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

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Precia
Dosage Form : INJ
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
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

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Precedex
Dosage Form : INJ
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
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

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DEXISUN
Dosage Form : INF
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DEMETEV
Dosage Form : INF
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Demodinex
Dosage Form : INJ
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Solution for Infusion
Dosage Strength : 4MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Packaging :
Regulatory Info :
Dosage : Solution for Infusion
Dosage Strength : 4MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Vial
Dosage Strength : 100MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Packaging :
Regulatory Info :
Dosage : Vial
Dosage Strength : 100MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name :
Dosage Form : Concentrate for Soluti...
Dosage Strength : 100MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Packaging :
Regulatory Info :
Dosage : Concentrate for Soluti...
Dosage Strength : 100MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : Austria
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Regulatory Info :
Registration Country : India
Brand Name : Dexmedetomidine
Dosage Form : Injection
Dosage Strength : 0.5MG/ML
Packaging : 10 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : 10 ML
Regulatory Info :
Dosage : Injection
Dosage Strength : 0.5MG/ML
Brand Name : Dexmedetomidine
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : Iran
Brand Name : Aro-midin
Dosage Form : Injection
Dosage Strength : 200MCG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran

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Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 200MCG/2ML
Brand Name : Aro-midin
Approval Date :
Application Number :
Registration Country : Iran

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Regulatory Info :
Registration Country : South Korea
Brand Name : Medetin
Dosage Form : Injectable
Dosage Strength : 1MG/ML
Packaging : 10ML Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea

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Packaging : 10ML Vial
Regulatory Info :
Dosage : Injectable
Dosage Strength : 1MG/ML
Brand Name : Medetin
Approval Date :
Application Number :
Registration Country : South Korea

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Regulatory Info : US ANDA- Submitted
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MCG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : US ANDA- Submitted
Registration Country : China

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Packaging :
Regulatory Info : US ANDA- Submitted
Dosage : Injection
Dosage Strength : 200MCG/2ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China

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Regulatory Info :
Registration Country : India
Brand Name : Dexmedetomidine Hydroc...
Dosage Form : Liquid Injection
Dosage Strength : 100MCG/ML
Packaging : 2 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : 2 ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 100MCG/ML
Brand Name : Dexmedetomidine Hydroc...
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name : Dexem 0.5
Dosage Form : Injection
Dosage Strength : 100MCG/ML
Packaging : 1x0.5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : 1x0.5
Regulatory Info :
Dosage : Injection
Dosage Strength : 100MCG/ML
Brand Name : Dexem 0.5
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name : Dexem 2
Dosage Form : Injection
Dosage Strength : 100MCG/ML
Packaging : 1x2
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : 1x2
Regulatory Info :
Dosage : Injection
Dosage Strength : 100MCG/ML
Brand Name : Dexem 2
Approval Date :
Application Number :
Registration Country : India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
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. Customised packaging (from grams to kilogra...
Ingredient(s) : Sodium Acetate Excipient
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
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 packaging (from grs to kilograms)
Ingredient(s) : Sodium Chloride Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dosage Form : Solution
Grade : Oral
Brand Name : Sodium Acetate 3-Hydrate
Application : API Stability Enhancers
Excipient Details : Sodium Acetate 3-hydrate is used as antimicrobial preservative and pH-modifier in oral liquid dosage forms.
Pharmacopoeia Ref : Ph. Eur.|USP
Technical Specs : Not Available
Ingredient(s) : Sodium Acetate Excipient
Dosage Form : Solution
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Application : Parenteral
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...
Ingredient(s) : Sodium Chloride Excipient
Application : Parenteral
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...
Ingredient(s) : Sodium Acetate Excipient
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Excipients Web Link
Brand Name : NaCl Multi-compendial Low Endotoxin
Application : Parenteral
Excipient Details : A & C's Sodium Chloride multi-compendial low endotoxin is an excipient meeting USP-NF, EP, BP and JP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Low Endotoxin
Ingredient(s) : Sodium Chloride Excipient
Excipients Web Link
Brand Name : Sodium Acetate 3-Hydrate
Application : API Stability Enhancers
Excipient Details : Sodium Acetate 3-hydrate is used as antimicrobial preservative and pH-modifier in oral liquid dosage forms.
Pharmacopoeia Ref : Ph. Eur.|USP
Technical Specs : Not Available
Ingredient(s) : Sodium Acetate Excipient
https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions
Global Sales Information
Company : Bioxcel Therape
Dexmedetomidine HCl
Drug Cost (USD) : 64,689
Year : 2023
Prescribers : 15
Prescriptions : 24

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
Patent Expiration Date : 2032-07-04
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

Patent Expiration Date : 2032-07-04
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

Patent Expiration Date : 2032-07-04
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

Patent Expiration Date : 2032-07-04
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Patent Expiration Date : 2019-03-31
Date Granted : 2008-12-23
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

Patent Expiration Date : 2012-11-28
Date Granted : 1995-11-28
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

Patent Expiration Date : 2012-11-28
Date Granted : 1995-11-28
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

Patent Expiration Date : 2032-09-27
Date Granted : 2017-11-28
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

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
CAS Number :
Quantity Per Vial :
Sale Unit :
Price : $310.00
Details :
Monograph : PHR2701-500MG
Storage : +2°C to +30°C
Code/Batch No :
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).