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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":"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":1729017000,"product":"CINACALCET HYDROCHLORIDE IHS","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"102.68","actualQuantity":"102.68","unit":"KGS","unitRateFc":"1591","totalValueFC":"164969.3","currency":"USD","unitRateINR":"135000","date":"16-Oct-2024","totalValueINR":"13861800","totalValueInUsd":"164969.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"6142582","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,"},{"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"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730399400,"product":"CINACALCET HYDROCHLORIDE IHS","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":"102.33","actualQuantity":"102.33","unit":"KGS","unitRateFc":"1589.2","totalValueFC":"163702.4","currency":"USD","unitRateINR":"135000","date":"01-Nov-2024","totalValueINR":"13814550","totalValueInUsd":"163702.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"6449441","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD, N.NARASAPURAM (V), NAKKAPALLI (M) SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"CINACALCET HYDROCHLORIDE IHS","address":"ALKEM HOUSE, DEVASHISH ADJACENT T","city":"MUMBAI,MAHARASHTRA","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"256.30","actualQuantity":"256.3","unit":"KGS","unitRateFc":"1575.7","totalValueFC":"406541.4","currency":"USD","unitRateINR":"133856","date":"02-Nov-2024","totalValueINR":"34307292.8","totalValueInUsd":"406541.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"6455027","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 T"}]
    05-Jan-2021
    31-Dec-2024
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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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    ABOUT THIS PAGE

    Looking for 364782-34-3 / Cinacalcet API manufacturers, exporters & distributors?

    Cinacalcet manufacturers, exporters & distributors 1

    96

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cinacalcet manufacturer or Cinacalcet supplier.

    PharmaCompass also assists you with knowing the Cinacalcet API Price utilized in the formulation of products. Cinacalcet API Price is not always fixed or binding as the Cinacalcet Price is obtained through a variety of data sources. The Cinacalcet Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Cinacalcet

    Synonyms

    364782-34-3, Cinacalcet hcl, Sensipar, Mimpara, Amg073 hcl, Regpara

    Cas Number

    364782-34-3

    Unique Ingredient Identifier (UNII)

    1K860WSG25

    About Cinacalcet

    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.

    Cinacalcet Hydrochloride Manufacturers

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

    Cinacalcet Hydrochloride Suppliers

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

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

    Cinacalcet Hydrochloride USDMF

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

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

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

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

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

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

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

    Cinacalcet Hydrochloride WC

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

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

    Cinacalcet Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Cinacalcet Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cinacalcet Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

    Cinacalcet Hydrochloride GMP

    Cinacalcet Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Cinacalcet Hydrochloride GMP API supplier for your needs.

    Cinacalcet Hydrochloride CoA

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

    Cinacalcet Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cinacalcet Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cinacalcet Hydrochloride EP), Cinacalcet Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cinacalcet Hydrochloride 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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