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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

    API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"CINACALCET HYDROCHLORIDE(QTY:2 X 0.2G, VALUE: USD 13.95\/EACH) (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":"0.0004","unit":"KGS","unitRateFc":"69750","totalValueFC":"29.4","currency":"USD","unitRateINR":"6129725","date":"26-Jun-2024","totalValueINR":"2451.89","totalValueInUsd":"29.4","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"CINACALCET HYDROCHLORIDE IHS","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"101.12","actualQuantity":"101.12","unit":"KGS","unitRateFc":"1565.1","totalValueFC":"160097.4","currency":"USD","unitRateINR":"132800","date":"22-Aug-2024","totalValueINR":"13428736","totalValueInUsd":"160097.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"5183649","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"CINACALCET HYDROCHLORIDE IH","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"51.46","actualQuantity":"51.46","unit":"KGS","unitRateFc":"1589.2","totalValueFC":"82677.4","currency":"USD","unitRateINR":"135000","date":"26-Oct-2024","totalValueINR":"6947100","totalValueInUsd":"82677.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"6344485","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"}]
    20-Jan-2021
    31-Dec-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
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    INTERMEDIATES SUPPLIERS

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    01

    Minakem

    France
    DCAT Week
    Attending
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    Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

    (R )-(+)-1-(1-Naphtyl)-ethylamine Hydrochloride

    CAS Number : 82572-04-1

    End Use API : Cinacalcet Hydrochloride

    About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...

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    02

    DKSH

    Switzerland
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    Booth #8.0P66
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    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    1 ACETYL NAPHTHALENE  (1 ACETONAPHTHONE)

    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 ...

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    03

    Malladi Drugs & Pharmaceuticals Lim...

    India
    Biotech Showcase
    Not Confirmed
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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

    R-Naphthylethyl amine

    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

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    04

    Anvitha Lifecare

    India
    Biotech Showcase
    Not Confirmed
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    Anvitha Lifecare

    India
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    (R)-Naphthylethylamine

    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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    05

    ARRAN CHEMICAL COMPANY

    Ireland
    Biotech Showcase
    Not Confirmed
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    ARRAN CHEMICAL COMPANY

    Ireland
    Biotech Showcase
    Not Confirmed
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    R)-(+)-1-(1-Naphthyl)ethylamine

    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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    06

    Enzymaster (Ningbo) Bio-Engineering

    China
    Biotech Showcase
    Not Confirmed
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    Enzymaster (Ningbo) Bio-Engineering

    China
    Biotech Showcase
    Not Confirmed
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    (R)-1-(1-Naphthyl)ethylamine

    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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    07

    LifeFirst Pharma

    India
    Biotech Showcase
    Not Confirmed
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    LifeFirst Pharma

    India
    Biotech Showcase
    Not Confirmed
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    (R)-1-(Naphthalen-1-yl)ethanamine

    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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    08

    Mehta API

    India
    Biotech Showcase
    Not Confirmed
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    Mehta API

    India
    Biotech Showcase
    Not Confirmed
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    3-(3'-Trifluoromethylphenyl)propanol

    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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    09

    RR LIFESCIENCES

    India
    Biotech Showcase
    Not Confirmed
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    RR LIFESCIENCES

    India
    Biotech Showcase
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    3-(3-(Trifluoromethyl)phenyl)propan-1-ol

    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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    10

    Shenzhen Oriental Pharmaceutial Co....

    China
    Biotech Showcase
    Not Confirmed
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    Shenzhen Oriental Pharmaceutial Co....

    China
    Biotech Showcase
    Not Confirmed
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    R-(+)-l-(l-naphthyl) ethylamine

    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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    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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    USP

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    ABOUT THIS PAGE

    Cinacalcet Manufacturers

    A Cinacalcet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cinacalcet, including repackagers and relabelers. The FDA regulates Cinacalcet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cinacalcet 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 Cinacalcet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Cinacalcet Suppliers

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

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

    Cinacalcet USDMF

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

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

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

    Cinacalcet JDMF

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

    The Cinacalcet Drug Master File in Japan (Cinacalcet JDMF) empowers Cinacalcet 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 Cinacalcet JDMF during the approval evaluation for pharmaceutical products. At the time of Cinacalcet 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 Cinacalcet suppliers with JDMF on PharmaCompass.

    Cinacalcet KDMF

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

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

    After submitting a Cinacalcet 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 Cinacalcet API can apply through the Korea Drug Master File (KDMF).

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

    Cinacalcet WC

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

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

    Cinacalcet NDC

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

    Finished drug products

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

    Unfinished drugs

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

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

    Compounded drug products

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

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

    Cinacalcet GMP

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

    Cinacalcet CoA

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

    Cinacalcet CoA mostly includes findings from lab analyses of a specific batch. For each Cinacalcet 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.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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