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Chemistry

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Also known as: 364782-34-3, Cinacalcet hcl, Sensipar, Mimpara, Amg073 hcl, Regpara
Molecular Formula
C22H23ClF3N
Molecular Weight
393.9  g/mol
InChI Key
QANQWUQOEJZMLL-PKLMIRHRSA-N
FDA UNII
1K860WSG25

Cinacalcet Hydrochloride
Cinacalcet Hydrochloride is the orally bioavailable hydrochloride salt of the calcimimetic cinacalcet. Cinacalcet increases the sensitivity of calcium-sensing receptors on chief cells in the parathyroid gland to extracellular calcium, thereby reducing parathyroid hormone (PTH) secretion. A reduction in PTH levels inhibits osteoclast activity, which may result in a decrease in cortical bone turnover and bone fibrosis, and normalization of serum calcium and phosphorus levels. In addition, by reducing PTH levels, cinacalcet may reduce PSA levels; PTH appears to raise PSA levels and may increase prostate cancer cell growth.
1 2D Structure

Cinacalcet Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[(1R)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C22H22F3N.ClH/c1-16(20-13-5-10-18-9-2-3-12-21(18)20)26-14-6-8-17-7-4-11-19(15-17)22(23,24)25;/h2-5,7,9-13,15-16,26H,6,8,14H2,1H3;1H/t16-;/m1./s1
2.1.3 InChI Key
QANQWUQOEJZMLL-PKLMIRHRSA-N
2.1.4 Canonical SMILES
CC(C1=CC=CC2=CC=CC=C21)NCCCC3=CC(=CC=C3)C(F)(F)F.Cl
2.1.5 Isomeric SMILES
C[C@H](C1=CC=CC2=CC=CC=C21)NCCCC3=CC(=CC=C3)C(F)(F)F.Cl
2.2 Other Identifiers
2.2.1 UNII
1K860WSG25
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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)-

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 393.9 g/mol
Molecular Formula C22H23ClF3N
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count6
Exact Mass393.1471119 g/mol
Monoisotopic Mass393.1471119 g/mol
Topological Polar Surface Area12 Ų
Heavy Atom Count27
Formal Charge0
Complexity422
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameCinacalcet hydrochloride
PubMed HealthCinacalcet (By mouth)
Drug ClassesCalcium Regulator
Drug LabelSensipar (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 IngredientCinacalcet hydrochloride
Dosage FormTablet
Routeoral
Strength60mg; 30mg; 90mg
Market StatusTentative Approval
CompanyTeva Pharms; Barr

2 of 4  
Drug NameSensipar
Drug LabelSensipar (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 IngredientCinacalcet hydrochloride
Dosage FormTablet
RouteOral
Strengtheq 90mg base; eq 30mg base; eq 60mg base
Market StatusPrescription
CompanyAmgen

3 of 4  
Drug NameCinacalcet hydrochloride
PubMed HealthCinacalcet (By mouth)
Drug ClassesCalcium Regulator
Drug LabelSensipar (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 IngredientCinacalcet hydrochloride
Dosage FormTablet
Routeoral
Strength60mg; 30mg; 90mg
Market StatusTentative Approval
CompanyTeva Pharms; Barr

4 of 4  
Drug NameSensipar
Drug LabelSensipar (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 IngredientCinacalcet hydrochloride
Dosage FormTablet
RouteOral
Strengtheq 90mg base; eq 30mg base; eq 60mg base
Market StatusPrescription
CompanyAmgen

4.2 Drug Indication

* 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


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Increased Calcium-sensing Receptor Sensitivity [MoA]; Calcium-sensing Receptor Agonist [EPC]
5.3 ATC Code

H05BX01


H05BX01


H05BX01


H05BX01


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Cinacalcet Hydrochloride IH

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Date of Issue : 2019-06-26

Valid Till : 2022-06-25

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Date of Issue : 2022-06-08

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Date of Issue : 2019-07-22

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Date of Issue : 2019-08-09

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Date of Issue : 2022-06-03

Valid Till : 2025-05-27

Written Confirmation Number : WC-0003

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Cinacalcet Hydrochloride (IH)

Date of Issue : 2019-11-28

Valid Till : 2022-07-02

Written Confirmation Number : WC-0079

Address of the Firm : Plot No.2209, GIDC, Industrial Estate, At & Post Sarigam, Tal-Umbergaon, Valsad-...

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10

Mehta API

India
ASC 2024
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Mehta API

India
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ASC 2024
Not Confirmed

Cinacalcet Hydrochloride IH

Date of Issue : 2020-02-14

Valid Till : 2022-07-02

Written Confirmation Number : WC-0214

Address of the Firm : Gut No. 546, 571, 519 & 520, Village: Kumbhavali, Tarapur, Boisar, Tal & DIst- P...

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Listed Suppliers

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01

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  • WHO-GMP

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

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Cinacalcet Hydrochloride

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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02

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Virtual BoothASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.

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Cinacalcet Hydrochloride

About the Company : Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality,...

Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality, embedding our values into every endeavor. Our aim is to cultivate mutually beneficial relationships with customers, suppliers, and ourselves, fostering sustainable growth. Empowered by visionary leadership and a quality-driven team, ASolution is steadfast in providing innovative solutions to challenges such as Process Development, Optimization, Drug Product and Substance Manufacturing, and more.
ASolution Pharmaceuticals

03

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  • EDQM
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Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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Cinacalcet

About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...

Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It also offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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04

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  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Cinacalcet Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

05

Medichem S.A

Spain
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Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Cinacalcet Hydrochloride

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
Medichem

06

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  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

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Cinacalcet Hydrochloride

About the Company : Megafine, established in 1995, is a privately owned and professionally managed enterprise with its corporate office in MUMBAI and two multipurpose manufacturing sites at VAPI & NAS...

Megafine, established in 1995, is a privately owned and professionally managed enterprise with its corporate office in MUMBAI and two multipurpose manufacturing sites at VAPI & NASHIK in India for APIs & Intermediates. The facilities have been successfully inspected by US-FDA, EDQM, Japan PMDA, Health Canada, TGA Australia, ANVISA Brazil, COFEPRIS Mexico, Korea MFDS & WHO besides being certified for ISO 9001:2008, 14001:2004 & OHSAS 18001:2007. The company focuses on niche molecules for the regulated market globally.
Megafine Pharma

07

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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Cinacalcet Hydrochloride

About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...

Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk actives. We are dedicated to enhancing patients' quality of life by offering products that are safe, effective, high-quality, and affordable. Bal Pharma's APIs and FDFs are produced at world-class manufacturing facilities. Our APIs are widely exported to Europe, the Far East, Latin America, Africa, the Middle East, and other global markets. Our FDFs are exported to semi-regulated and non-regulated markets, and we are now entering regulated markets.
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08

ASC 2024
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Cinacalcet Hydrochloride

About the Company : Ningbo Zhenlei Chemical Co.,ltd. located in ningbo city, zhejiang province. We are specializes in R&D, manufacturing and marketing. Our main product is R-3-amino-1-butanol, Sitagli...

Ningbo Zhenlei Chemical Co.,ltd. located in ningbo city, zhejiang province. We are specializes in R&D, manufacturing and marketing. Our main product is R-3-amino-1-butanol, Sitagliptin, Sitagliptin phosphate monohydrate. With strong experience and network in Pharmaceutical and Agrochemical, across the globe, Zhenlei is your ideal partner for development of multi-scale synthesis projects as well as manufacturing activities, by ensuring reliable sourcing of raw materials, at competitive pricing and suitable packaging.
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Rampex Labs

India
ASC 2024
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Rampex Labs

India
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Cinacalcet Hydrochloride

About the Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with commercial operatio...

We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with commercial operations starting initially by outsourcing our production. In January 2008, our own production became operational and our journey really began. From our inception, we have strived to be the best and work with the best. Our client list comprises of some of the leading API producers within India and abroad. We at Rampex strongly believe that commitment to quality and timely deliveries ensure a very smooth working relationship with all our customers.
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Cinacalcet Hydrochloride

About the Company : Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer. We have a legacy of over three decades and trace our origins to the API e...

Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer. We have a legacy of over three decades and trace our origins to the API expertise of Strides Shasun Ltd. and the technical know-how of human API business from Sequent Scientific Ltd. We are poised to bridge the industry gap by delivering value based products while maintaining focus on the customer needs. We have 140+ scientists working at our two R&D Centers and 4 API manufacturing facilities armed with global approvals and 2 dedicated R&D facilities.
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API Reference Price

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MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"20.07","actualQuantity":"20.07","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"42428.8","currency":"USD","unitRateINR":"175979.3","date":"07-Dec-2023","totalValueINR":"3531903.55","totalValueInUsd":"42428.8","indian_port":"Delhi Air","hs_no":"29214290","bill_no":"9112485","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701887400,"product":"CINACALCET HCL","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"29.35","actualQuantity":"29.35","unit":"KGS","unitRateFc":"2092.5","totalValueFC":"62047","currency":"USD","unitRateINR":"175979.3","date":"07-Dec-2023","totalValueINR":"5164990.99","totalValueInUsd":"62047","indian_port":"Delhi Air","hs_no":"29214290","bill_no":"9112485","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"CINACALCET HYDROCHLORIDE(QTY:1 X 250 MG, VALUE: USD422) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"1688000","totalValueFC":"444.3","currency":"USD","unitRateINR":"148343960","date":"26-Jun-2024","totalValueINR":"37085.99","totalValueInUsd":"444.3","indian_port":"Hyderabad Air","hs_no":"29214990","bill_no":"4196499","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]
21-Jan-2021
23-Aug-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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Average Price
(USD/KGS)
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Drugs in Development

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Details:

Cinacalcet Tablets is a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).


Lead Product(s): Cinacalcet Hydrochloride

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 01, 2020

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Lead Product(s) : Cinacalcet Hydrochloride

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Cinacalcet Tablets is a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 01, 2020

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INTERMEDIATES SUPPLIERS

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01

Minakem

France
  • fda
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Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

CAS Number : 82572-04-1

End Use API : Cinacalcet Hydrochloride

About The Company : Minakem is a fully integrated development partner and commercial manufacturer for pharma companies. With around 70 years of experience, Minakem is a technology-...

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02

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

CAS Number : 941-98-0

End Use API : Cinacalcet Hydrochloride

About The Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It ...

DKSH Company Banner

03

  • fda
  • EDQM
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Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

04

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CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : Established in 2016, a state-of-the-art R&D facility engaged in the development of Novel processes for Bulk Actives including Deuterated Actives, Advanced Inter...

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CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : Arran is an independent fine chemical company located near Athlone, Ireland. Our range of pharmaceutical intermediates includes alkylamines and hydrochlorides, ...

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CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : Based on the excellent enzymatic technology platform, Enzymaster Chemical applies innovative technology to realize its commercial production of chiral compounds...

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CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : We believe in attaining the highest levels of customer satisfaction and social welfare with the philosophy of keeping first things first. Our systematic interve...

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Mehta API

India
ASC 2024
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Mehta API

India
ASC 2024
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CAS Number : 78573-45-2

End Use API : Cinacalcet Hydrochloride

About The Company : Mehta API Pvt Ltd engaged in manufacturing and marketing of APIs & Advance Drug Intermediates.... Globally. Mehta Api has been inordinately proud of its achieve...

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ASC 2024
Not Confirmed
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CAS Number : 78573-45-2

End Use API : Cinacalcet Hydrochloride

About The Company : RR LIFESCIENCES manufactures products purely by organic synthesis to offer its customers a choice of products in their areas. Our facilities are equipped with a...

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CAS Number : 3886-70-2

End Use API : Cinacalcet Hydrochloride

About The Company : Founded in 1995, Shenzhen Oriental Pharma focussed on the production of Active Pharma Ingredients (APIs), Now the main product is Phenylephrine Hcl (PE), Doxyla...

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FDF Dossiers

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01

  • fda
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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Regulatory Info :

Registration Country : India

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 90MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

04

  • fda
  • EDQM
  • WHO-GMP

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

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Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

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

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Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

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

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Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Packaging :

Approval Date : 2020-09-18

Application Number : 208368

Regulatory Info : RX

Registration Country : USA

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

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Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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

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Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 60 mg

Packaging : 28 UNITS 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Regulatory Info :

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Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 90 mg

Packaging : 28 UNITS 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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  • fda
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Regulatory Info : RX

Registration Country : USA

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2018-04-30

Application Number : 209226

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science
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FDA Orange Book

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DR REDDYS

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

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RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DR REDDYS

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

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Digital Content Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DR REDDYS

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

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Approval Date : 2020-09-18

Application Number : 208368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

  • fda
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  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

05

  • fda
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  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

07

ACCORD HLTHCARE

United Kingdom
ASC 2024
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
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ASC 2024
Not Confirmed

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2020-05-15

Application Number : 211892

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2018-12-27

Application Number : 204377

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

BARR

U.S.A
ASC 2024
Not Confirmed
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BARR

U.S.A
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ASC 2024
Not Confirmed

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Dosage Strength : 90MG

Approval Date :

Application Number : 90476

RX/OTC/DISCN :

RLD :

TE Code :

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10

CIPLA

India
ASC 2024
Not Confirmed
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CIPLA

India
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ASC 2024
Not Confirmed

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2018-03-08

Application Number : 208915

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Europe

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

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Regulatory Info :

Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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

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Registration Country : Italy

Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 60 mg

Packaging : 28 UNITS 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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

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Cinacalcet

Brand Name : CINACALCET DR REDDY'S

Dosage Form : Film-Coated Tablets

Dosage Strength : 90 mg

Packaging : 28 UNITS 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Accord Healthcare Ltd.

United Kingdom
ASC 2024
Not Confirmed
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Accord Healthcare Ltd.

United Kingdom
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Not Confirmed

Cinacalcet Hydrochloride

Brand Name : Cinacalcet Accord

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 90 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

ASC 2024
Not Confirmed
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ASC 2024
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cinakalcethydroklorid

Brand Name : Mimpara

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 60 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

Cinacalcet

Brand Name : MIMPARA

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

Cinacalcet

Brand Name : CINACALCET AUROBINDO

Dosage Form : Film-Coated Tablets

Dosage Strength : 30 mg

Packaging : 28 UNITS 30 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

Cinacalcet Hydrochloride

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 90MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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09

Devatis AG

Switzerland
ASC 2024
Not Confirmed
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Devatis AG

Switzerland
arrow
ASC 2024
Not Confirmed

Cinacalcetum

Brand Name : Cinacalcet Devatis

Dosage Form : Filmtabl

Dosage Strength : 30mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Mylan S.A.S.

U.S.A
ASC 2024
Not Confirmed
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Mylan S.A.S.

U.S.A
arrow
ASC 2024
Not Confirmed

Cinacalcet Hydrochloride

Brand Name : Cinacalcet Mylan

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 90 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 30MG BASE

USFDA APPLICATION NUMBER - 21688

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DOSAGE - TABLET;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 21688

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DOSAGE - TABLET;ORAL - EQ 90MG BASE

USFDA APPLICATION NUMBER - 21688

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