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Synopsis

Synopsis

Chemistry

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Also known as: 129318-43-0, Fosamax, Binosto, Fosamac, Onclast, Monosodium alendronate
Molecular Formula
C4H12NNaO7P2
Molecular Weight
271.08  g/mol
InChI Key
CAKRAHQRJGUPIG-UHFFFAOYSA-M
FDA UNII
4988K7X26P

Alendronate Sodium
A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.
1 2D Structure

Alendronate Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate
2.1.2 InChI
InChI=1S/C4H13NO7P2.Na/c5-3-1-2-4(6,13(7,8)9)14(10,11)12;/h6H,1-3,5H2,(H2,7,8,9)(H2,10,11,12);/q;+1/p-1
2.1.3 InChI Key
CAKRAHQRJGUPIG-UHFFFAOYSA-M
2.1.4 Canonical SMILES
C(CC(O)(P(=O)(O)O)P(=O)(O)[O-])CN.[Na+]
2.2 Other Identifiers
2.2.1 UNII
4988K7X26P
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-amino-1-hydroxybutylidene 1,1-biphosphonate

2. Alendronate

3. Alendronate Monosodium Salt, Trihydrate

4. Aminohydroxybutane Bisphosphonate

5. Fosamax

6. Mk 217

7. Mk-217

8. Mk217

2.3.2 Depositor-Supplied Synonyms

1. 129318-43-0

2. Fosamax

3. Binosto

4. Fosamac

5. Onclast

6. Monosodium Alendronate

7. Alendronate Sodium Anhydrous

8. Alendronate Monosodium

9. Mk 217

10. Alendronic Acid Monosodium Salt

11. Mk-217

12. Sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate

13. Adrovance

14. Fosavance

15. G-704650

16. Vantavo

17. Onclast; Osteovan; Sodium Alendronate

18. 4988k7x26p

19. Osteovan

20. Indrol

21. Alend

22. Neobon

23. Alendronate (as Sodium)

24. Phosphonic Acid, (4-amino-1-hydroxybutylidene)bis-, Monosodium Salt

25. Nsc-722597

26. Nsc-758931

27. Almerol

28. Avalent

29. Bonalon

30. Steovess

31. Teiroc

32. Unii-4988k7x26p

33. Ahbutbp

34. Ahbubp

35. (4-amino-1-hydroxybutylidene)bisphosphonic Acid Monosodium Salt

36. Chembl675

37. Alendronic Acid Sodium Salt

38. Gth-42j

39. Gth-42v

40. Gth-42w

41. Schembl328770

42. Gth-42

43. Dtxsid70904501

44. Mer-103

45. Hms3604i12

46. Hms3713p04

47. Sodium Alendronate Anhydrous

48. Bcp28464

49. Alendronic Acid, Sodium Aldendronate

50. Bdbm50247920

51. Ex-101

52. Mfcd01861681

53. Akos015895071

54. Ccg-220631

55. Ks-1028

56. Mk-0217

57. Hy-108685

58. Cs-0029477

59. Mk 217;mk-217;mk217;sodium Alendronate

60. A805927

61. J-005667

62. L-670452

63. Q27259256

64. Monosodium (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate

65. Sodium Hydrogen-4-amino-1-hydroxy-1-phosphonobutylphosphonate

66. (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt

67. 4-amino-1-hydroxybutylidene-1,1-bisphosphonic Acid Monosodium Salt

68. P,p'-(4-amino-1-hydroxybutylidene)bis-phosphonic Acid Monosodium Salt

69. Phosphonic Acid, P,p'-(4-amino-1-hydroxybutylidene)bis-, Sodium Salt (1:1)

2.4 Create Date
2007-11-13
3 Chemical and Physical Properties
Molecular Weight 271.08 g/mol
Molecular Formula C4H12NNaO7P2
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass270.99867000 g/mol
Monoisotopic Mass270.99867000 g/mol
Topological Polar Surface Area164 Ų
Heavy Atom Count15
Formal Charge0
Complexity293
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameAlendronate sodium
PubMed HealthAlendronate (By mouth)
Drug ClassesCalcium Regulator
Drug LabelFOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active IngredientAlendronate sodium
Dosage FormTablet; Solution
RouteOral
Strengtheq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml
Market StatusPrescription
CompanyWatson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane

2 of 6  
Drug NameBinosto
Drug LabelBINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chem...
Active IngredientAlendronate sodium
Dosage FormTablet, effervescent
RouteOral
Strengtheq 70mg base
Market StatusPrescription
CompanyMission Pharma

3 of 6  
Drug NameFosamax
PubMed HealthAlendronate (By mouth)
Drug ClassesCalcium Regulator
Drug LabelFOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active IngredientAlendronate sodium
Dosage FormTablet; Solution
RouteOral
Strengtheq 70mg base; eq 70mg base/75ml
Market StatusPrescription
CompanyMerck; Merck And

4 of 6  
Drug NameAlendronate sodium
PubMed HealthAlendronate (By mouth)
Drug ClassesCalcium Regulator
Drug LabelFOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active IngredientAlendronate sodium
Dosage FormTablet; Solution
RouteOral
Strengtheq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml
Market StatusPrescription
CompanyWatson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane

5 of 6  
Drug NameBinosto
Drug LabelBINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chem...
Active IngredientAlendronate sodium
Dosage FormTablet, effervescent
RouteOral
Strengtheq 70mg base
Market StatusPrescription
CompanyMission Pharma

6 of 6  
Drug NameFosamax
PubMed HealthAlendronate (By mouth)
Drug ClassesCalcium Regulator
Drug LabelFOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active IngredientAlendronate sodium
Dosage FormTablet; Solution
RouteOral
Strengtheq 70mg base; eq 70mg base/75ml
Market StatusPrescription
CompanyMerck; Merck And

4.2 Drug Indication

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Adrovance reduces the risk of vertebral and hip fractures.


Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Fosavance reduces the risk of vertebral and hip fractures.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Bone Density Conservation Agents

Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Diphosphonates [CS]; Bisphosphonate [EPC]
5.3 ATC Code

M05BB03


M05BB03


API SUPPLIERS

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Polpharma

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Sanofi

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Octavius Pharma Pvt. Ltd

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Polpharma

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Alendronate Sodium

About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Alendronate Sodium

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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Alendronate Sodium

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 & 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 & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.
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Alendronate sodium trihydrate

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
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Alendronate Sodium

About the Company : Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable ...

Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.
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India
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About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...

Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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Fosamax

About the Company : Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Ant...

Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Antithrombotic, Analgesic. In 2012 Globe Quimica has started-up its new API plant for Active Ingredients for Oncologic Drugs.
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Alendronate Sodium

About the Company : SWATI SPENTOSE PVT. LTD.(SSPL), a pharmaceutical company based in Mumbai, India having 2 manufacturing sites: SSPL Unit 1 and SSPL Unit 2. Please find attached a brief presentation...

SWATI SPENTOSE PVT. LTD.(SSPL), a pharmaceutical company based in Mumbai, India having 2 manufacturing sites: SSPL Unit 1 and SSPL Unit 2. Please find attached a brief presentation on our company. A USFDA inspected & WHO-GMP certified site, with 3 CEP’S as well as UK-MHRA, EDQM and TGA-Australia compliant API manufacture, specializing in manufacture of Polysaccharides.
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13-Jan-2021
26-Oct-2024
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Average Price (USD/KGS)

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

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20560

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DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20560

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DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20560

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DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20560

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DOSAGE - TABLET;ORAL - EQ 70MG BASE

USFDA APPLICATION NUMBER - 20560

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DOSAGE - TABLET;ORAL - EQ 70MG BASE;2,800 IU

USFDA APPLICATION NUMBER - 21762

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DOSAGE - TABLET;ORAL - EQ 70MG BASE;5,600 IU

USFDA APPLICATION NUMBER - 21762

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