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1. Alpha-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-1-naphthalenemethanamine, (alphar)-hydrochloride
2. Amg 073
3. Amg073
4. Cinacalcet
5. Krn 1493
6. Sensipar
1. 364782-34-3
2. Cinacalcet Hcl
3. Sensipar
4. Mimpara
5. Amg073 Hcl
6. Regpara
7. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hydrochloride
8. Cinacalcet, Hcl
9. Cinacalcet Hydrochloride [usan]
10. Cinacalcet (hydrochloride)
11. Amg-073 Hcl
12. Amg073 Hydrochloride
13. Chebi:48391
14. 1k860wsg25
15. Parareg
16. N-[(1r)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine;hydrochloride
17. Amg-073 Hcl (cinacalcet Hydrochloride)
18. 364782-34-3 (hcl)
19. [(1r)-1-(naphthalen-1-yl)ethyl]({3-[3-(trifluoromethyl)phenyl]propyl})amine Hydrochloride
20. Dsstox_cid_26792
21. Dsstox_rid_81909
22. N-((1r)-1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hydrochloride
23. N-[(1r)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine Hydrochloride
24. Dsstox_gsid_46792
25. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoro-methyl)phenyl)propan-1-amine Hydrochloride
26. Smr002530058
27. Cas-364782-34-3
28. Krn 1493
29. Ncgc00181002-01
30. Amg 073 Hcl
31. Unii-1k860wsg25
32. Sensipar (tn)
33. Mimpara (tn)
34. Cnc-hcl
35. Cinacelcet Hydrochloride
36. Sensipar(tm)
37. Amg-073 Hydrochloride
38. Amg-073.hcl
39. Mls004774045
40. Mls006010213
41. Chembl1200776
42. Dtxsid3046792
43. Bcpp000409
44. Bcp02533
45. Nps-1493
46. Tox21_112654
47. Cinacalcet Hydrochloride (jan/usan)
48. Cinacalcet Hydrochloride [mi]
49. Hy-70037a
50. Mfcd08067750
51. S1260
52. Cinacalcet Hydrochloride [jan]
53. Akos005146514
54. Akos015969126
55. Tox21_112654_1
56. Ac-1799
57. Am90312
58. Bcp9000286
59. Ccg-268579
60. Cs-0288
61. Gs-4171
62. Cinacalcet Hydrochloride [mart.]
63. Cinacalcet Hydrochloride [usp-rs]
64. Cinacalcet Hydrochloride [who-dd]
65. Ncgc00181002-04
66. 1-naphthalenemethanamine, Alpha-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-, (alphar)-, Hydrochloride
67. Sw219246-1
68. Cinacalcet Hydrochloride [orange Book]
69. D03505
70. 782c343
71. J-520045
72. Q27121179
73. Z1741977003
74. (r)-n-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hcl
75. (r)-n-(3-(3-(trifluoromethyl)phenyl)propyl)-1- -(1-napthyl)ethylamine Hydrochloride
76. (alphar)-alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl)propyl]-1-napthalenemethanamine Hydrochloride
77. 1-naphthalenemethanamine, .alpha.-methyl-n-(3-(3-(trifluoromethyl)phenyl)propyl)-, (.alpha.r)-, Hydrochloride
78. 1-naphthalenemethanamine, Alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-, Hydrochloride (1:1), (alphar)-
79. 1-naphthalenemethanamine,a-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-, Hydrochloride, (ar)-
| Molecular Weight | 393.9 g/mol |
|---|---|
| Molecular Formula | C22H23ClF3N |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 6 |
| Exact Mass | 393.1471119 g/mol |
| Monoisotopic Mass | 393.1471119 g/mol |
| Topological Polar Surface Area | 12 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 422 |
| 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 | Cinacalcet hydrochloride |
| PubMed Health | Cinacalcet (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt... |
| Active Ingredient | Cinacalcet hydrochloride |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 60mg; 30mg; 90mg |
| Market Status | Tentative Approval |
| Company | Teva Pharms; Barr |
| 2 of 4 | |
|---|---|
| Drug Name | Sensipar |
| Drug Label | Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt... |
| Active Ingredient | Cinacalcet hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 90mg base; eq 30mg base; eq 60mg base |
| Market Status | Prescription |
| Company | Amgen |
| 3 of 4 | |
|---|---|
| Drug Name | Cinacalcet hydrochloride |
| PubMed Health | Cinacalcet (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt... |
| Active Ingredient | Cinacalcet hydrochloride |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 60mg; 30mg; 90mg |
| Market Status | Tentative Approval |
| Company | Teva Pharms; Barr |
| 4 of 4 | |
|---|---|
| Drug Name | Sensipar |
| Drug Label | Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3NHCl with a molecular weight of 393.9 g/mol (hydrochloride salt... |
| Active Ingredient | Cinacalcet hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 90mg base; eq 30mg base; eq 60mg base |
| Market Status | Prescription |
| Company | Amgen |
* Secondary hyperparathyroidism :
Adults
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Paediatric population
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4. 4).
Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5. 1).
* Parathyroid carcinoma and primary hyperparathyroidism in adults:
Reduction of hypercalcaemia in adult patients with:
- parathyroid carcinoma.
- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.
Reduction of hypercalcaemia in patients with:
- parathyroid carcinoma
- primary HPT for whom parathyroidectomy
would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
* Secondary hyperparathyroidism :
Adults
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy.
Paediatric population
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.
Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate.
Parathyroid carcinoma and primary hyperparathyroidism in adults.
Reduction of hypercalcaemia in adult patients with:
- parathyroid carcinoma;
- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5. 1).
Reduction of hypercalcaemia in patients with:
-parathyroid carcinoma.
- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium
levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Treatment of parathyroid carcinoma, Treatment of primary hyperparathyroidism , Treatment of secondary hyperparathyroidism in patients with end-stage renal disease
Calcimimetic Agents
Small organic molecules that act as allosteric activators of the calcium sensing receptor (CaSR) in the PARATHYROID GLANDS and other tissues. They lower the threshold for CaSR activation by extracellular calcium ions and diminish PARATHYROID HORMONE (PTH) release from parathyroid cells. (See all compounds classified as Calcimimetic Agents.)
Calcium-Regulating Hormones and Agents
Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)
H05BX01
H05BX01
H05BX01
H05BX01
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DMF Review : Reviewed
Rev. Date : 2013-09-22
Pay. Date : 2013-07-03
DMF Number : 27211
Submission : 2013-06-28
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-959
Start Marketing Date : 2015-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU, CA, RU |
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-25
Pay. Date : 2014-03-14
DMF Number : 21405
Submission : 2008-03-06
Status : Active
Type : II
NDC Package Code : 16436-0082
Start Marketing Date : 2010-06-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-23
Pay. Date : 2012-12-24
DMF Number : 24881
Submission : 2011-04-22
Status : Active
Type : II
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
Written Confirmation Number : WC-0087-(Annexure-1)
Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Village Lakhmapur, Taluka Dindori, Dist. Nashik-422 202, Maharashtra
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Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29494
Submission : 2015-06-24
Status : Active
Type : II
NDC Package Code : 49711-1517
Start Marketing Date : 2014-11-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-30
Pay. Date : 2014-08-04
DMF Number : 28156
Submission : 2014-03-27
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0126
Address of the Firm : R.S No.33 and 34 Mathur Road Periyakalapet, Punducherry India
Registrant Name : VOnBio Co., Ltd.
Registration Date : 2020-06-05
Registration Number : Number 4579-5-ND(2)
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : RS No.33 & 34 Mather Road, Periyakalapet, Puducherry-605014. India
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 30183
Submission : 2015-12-30
Status : Inactive
Type : II
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DOSAGE - TABLET;ORAL - EQ 30MG BASE
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Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2020 Revenue in Millions : 288
2019 Revenue in Millions : 551
Growth (%) : -48
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2020 Revenue in Millions : 115
2019 Revenue in Millions : 109
Growth (%) : 5
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2021 Revenue in Millions : 84
2020 Revenue in Millions : 288
Growth (%) : -71
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2021 Revenue in Millions : 87
2020 Revenue in Millions : 115
Growth (%) : -15
Main Therapeutic Indication : Endocrinology
Currency : USD
2022 Revenue in Millions : 46
2021 Revenue in Millions : 87
Growth (%) : -47
Main Therapeutic Indication : Endocrinology
Currency : USD
2022 Revenue in Millions : 64
2021 Revenue in Millions : 84
Growth (%) : -24
Main Therapeutic Indication : Endocrinology
Currency : USD
2023 Revenue in Millions : 38
2022 Revenue in Millions : 46
Growth (%) : -7
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2015 Revenue in Millions : 1,158
2014 Revenue in Millions : 1,415
Growth (%) : 22%
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2017 Revenue in Millions : 1,718
2016 Revenue in Millions : 1,582
Growth (%) : 9
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2018 Revenue in Millions : 1,774
2017 Revenue in Millions : 1,718
Growth (%) : 3%
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