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1. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol
2. Nucynta
3. Tapentadol
1. 175591-09-0
2. Tapentadol Hcl
3. Nucynta
4. Palexia
5. Tapentadol (hydrochloride)
6. Nucynta Er
7. Bn-200 Hydrochloride
8. Cg5503 Hydrochloride
9. Cg-5503 Hydrochloride
10. 3-((2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl)phenol Hydrochloride
11. 71204kii53
12. 175591-09-0 (hcl)
13. Tapentadol Hydrochloride (jan)
14. Tapentadol Hydrochloride [jan]
15. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride
16. Palexia Retard
17. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol Hydrochloride
18. Unii-71204kii53
19. Palexia Sr
20. Phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, Hydrochloride (1:1)
21. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride (1:1)
22. Nucynta (tn)
23. Schembl238138
24. Jns-024 Er
25. Chembl1201777
26. Dtxsid00938677
27. Amy25232
28. Hy-70042a
29. Mfcd00944992
30. Tapentadol Hydrochloride [mi]
31. Akos016842888
32. Cs-0879
33. Tapentadol Hydrochloride [mart.]
34. Tapentadol Hydrochloride [vandf]
35. Tapentadol Hydrochloride [who-dd]
36. Ac-32018
37. Tapentadol Hydrochloride [orange Book]
38. D10199
39. Tapentadol Hydrochloride [ep Monograph]
40. 591t238
41. Tapentadol Hydrochloride (1.0 Mg/ml In Methanol)
42. R-331333
43. Q27265914
44. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl) Phenol Hydrochloride
45. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol Hydrochloride
46. 3-[(2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride
47. 3-[1-(dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen Chloride (1/1)
48. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol Hydrochloride
49. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol Hydrochloride
50. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Monohydrochloride
51. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride
52. Phenol, 3-(3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride, (r-(r*,r*))-
53. Tapentadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
Molecular Weight | 257.80 g/mol |
---|---|
Molecular Formula | C14H24ClNO |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 5 |
Exact Mass | 257.1546421 g/mol |
Monoisotopic Mass | 257.1546421 g/mol |
Topological Polar Surface Area | 23.5 Ų |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 193 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
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 | Nucynta |
PubMed Health | Tapentadol (By mouth) |
Drug Classes | Analgesic |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml |
Market Status | Prescription |
Company | Janssen Pharms |
2 of 4 | |
---|---|
Drug Name | Nucynta er |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base |
Market Status | Prescription |
Company | Janssen Pharms |
3 of 4 | |
---|---|
Drug Name | Nucynta |
PubMed Health | Tapentadol (By mouth) |
Drug Classes | Analgesic |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml |
Market Status | Prescription |
Company | Janssen Pharms |
4 of 4 | |
---|---|
Drug Name | Nucynta er |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base |
Market Status | Prescription |
Company | Janssen Pharms |
Treatment of acute pain
Treatment of acute pain
Treatment of acute pain
Treatment of chronic pain
Treatment of chronic pain
Treatment of acute pain
Treatment of chronic pain
Adrenergic Uptake Inhibitors
Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)
Analgesics, Opioid
Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)
Certificate Number : CEP 2023-142 - Rev 00
Issue Date : 2024-10-31
Type : Chemical
Substance Number : 3035
Status : Valid
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm :
Available Reg Filing : ASMF |
Certificate Number : R0-CEP 2021-290 - Rev 00
Issue Date : 2022-11-24
Type : Chemical
Substance Number : 3035
Status : Valid
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28541
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-13
Pay. Date : 2012-11-02
DMF Number : 26490
Submission : 2012-09-27
Status : Active
Type : II
NDC Package Code : 17180-9780
Start Marketing Date : 2012-06-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-18
Pay. Date : 2017-03-30
DMF Number : 31435
Submission : 2017-03-27
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-18
Pay. Date : 2017-03-30
DMF Number : 31435
Submission : 2017-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28541
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-13
Pay. Date : 2012-11-02
DMF Number : 26490
Submission : 2012-09-27
Status : Active
Type : II
Tapentadol Hydrochloride IP/EP
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm : Plot No. 30 to 33 Phase-l, IDA Pashamylaram Patancheru IDA Pashamylaram, Sangare...
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm : Survey No.- 85 to 88, N.H. No.-8, Naugama, At & Post-Mandva, Tal. - Ankleshwar, ...
Date of Issue : 2020-04-15
Valid Till : 2023-05-19
Written Confirmation Number : WC-0281new2
Address of the Firm : Sy. No. 224/A, Bibinagar(V) & (M), Bhongir, Nalgonda District, Andhra Pradesh
Tapentadol tartarate IH/Tapentadol HCl IH
Date of Issue : 2018-01-01
Valid Till : 2020-05-19
Written Confirmation Number : WC-0281A3
Address of the Firm : Sy. No. 224/A, Bibinagar(V) & (M), Bhongir, Nalgonda District, Andhra Pradesh
Date of Issue : 2021-06-22
Valid Till : 2022-08-08
Written Confirmation Number : WC-0382A4
Address of the Firm : Unit -I Sy. No. 353 Domaguda Village Jinnaram Mandal Medak Dist T.S India
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 20MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
DRUG PRODUCT COMPOSITIONS
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Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
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Pharmacopoeia Ref : Ph. Eur., USP: Povidone; JPE: ...
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Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
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Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Capsule
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipient Details : For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP-JPE: 80 %...
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Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Film Formers & Plasticizers
Excipient Details : Liquid plasticizer with high ADI, hydrophilic solvent & humectant in emulsions, skin penetration enhancer in topical formulaitons.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Propylene Glycol
Dosage Form : Tablet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Dosage Form : Tablet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Povidone
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