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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


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SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"280","totalValueFC":"5105","currency":"USD","unitRateINR":"23309.8","date":"19-Jul-2023","totalValueINR":"419579.601","totalValueInUsd":"5105","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694197800,"product":"ALENDRONATE SODIUM TRIHYDRATE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"280","totalValueFC":"12244.6","currency":"EUR","unitRateINR":"25410","date":"09-Sep-2023","totalValueINR":"1016400","totalValueInUsd":"12244.6","indian_port":"Bombay Air","hs_no":"29319090","bill_no":"7749852","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"PELPLINSKA 19 83-200 STAROGARD GDANSKI Gdansk, PolandSDNF Poland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696357800,"product":"ALENDRONATE SODIUM TRIHYDRATE EP\/BP\/IP\/USP\/PH.(ALENDRONATE SODIUM TRIHYDRATE PH.EUR.)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"GDANSK","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"46.00","actualQuantity":"46","unit":"KGS","unitRateFc":"225","totalValueFC":"10452.1","currency":"USD","unitRateINR":"18911.3","date":"04-Oct-2023","totalValueINR":"869917.5","totalValueInUsd":"10452.1","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"8138602","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"GDANSK","supplierAddress":"83-200 Starogard Gdanski 19 Pelplinska STR. POLAND, , PolandSDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699381800,"product":"(RE-IMPORT REJECTED GOODS) ALENDRONATE SODIUM USP","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"MOLECULAS FINAS DE ","supplierCountry":"INDIA","foreign_port":"VERACRUZ","customer":"IPCA LABORATORIES","customerCountry":"INDIA","quantity":"9.34","actualQuantity":"9.34","unit":"KGS","unitRateFc":"136.5","totalValueFC":"1374.6","currency":"USD","unitRateINR":"12255.1","date":"08-Nov-2023","totalValueINR":"114462.52","totalValueInUsd":"1374.6","indian_port":"JNPT","hs_no":"29314990","bill_no":"8685407","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VERACRUZ","supplierAddress":"CARRETERA TEXCOCO LECHERIA KM 23.5S\/N INT. BDGA 4 101, LA MAGDALENA PANOAYA TEXCOCO, ESTADO DE MEXICO, C Mexico","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702060200,"product":"SODIUM ALENDRONATE TRIHYDRATE","address":"LINCOLN HOUSE, B\/H SATYAM","city":"AHMEDABAD ,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"LINCOLN PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"400","totalValueFC":"8101.6","currency":"USD","unitRateINR":"33720","date":"09-Dec-2023","totalValueINR":"674400","totalValueInUsd":"8101.6","indian_port":"Ahmedabad Air","hs_no":"29319090","bill_no":"9144377","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"U1. PELPLINSKA 19 83-200 STAROGARDGDANSKIPOLAND PL","customerAddress":"LINCOLN HOUSE, B\/H SATYAM"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703097000,"product":"ALENDRONATE SODIUM TRIHYDRATE EP\/BP\/IP\/USP\/PH.EUR. (ALENDRONATE SODIUM TRIHYDRATE)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"27.00","actualQuantity":"27","unit":"KGS","unitRateFc":"280","totalValueFC":"7656","currency":"USD","unitRateINR":"23604","date":"21-Dec-2023","totalValueINR":"637308","totalValueInUsd":"7656","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"9330836","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"83-200 Starogard Gdanski ul. Pelplinska 19 NIP: 592-02-02-822SDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"ALENDRONATE SODIUM TRIHYDRATE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"280","totalValueFC":"12425.3","currency":"EUR","unitRateINR":"25858","date":"30-Dec-2023","totalValueINR":"1034320","totalValueInUsd":"12425.3","indian_port":"Bombay Air","hs_no":"29319090","bill_no":"9479144","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"PELPLINSKA 19 83-200 STAROGARD GDANSKI Gdansk, , PolandSDNF Poland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705084200,"product":"SODIUM ALENDRONATE TRIHYDRATE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"N\/A","customer":"VIATRIS","customerCountry":"INDIA","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"242.1","totalValueFC":"134959.3","currency":"USD","unitRateINR":"20394","date":"13-Jan-2024","totalValueINR":"11216700","totalValueInUsd":"134959.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29319090","bill_no":"1000249","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"83-200 STAROGARD GSANSKI UL PELPLIN SKA 19 POLAND","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705602600,"product":"ALENDRONATE SODIUM(2985709)(FREE OF COST - VALUE FOR CUSTOMS PURPOSE ONLY)","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"XXD BXXLYDXXE","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"DIVIS LABORATORIES","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"87.8","totalValueFC":"355.1","currency":"USD","unitRateINR":"7379.3","date":"19-Jan-2024","totalValueINR":"29517","totalValueInUsd":"355.1","indian_port":"Vizag-DLL SEZ","hs_no":"29314990","bill_no":"1000058","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"N\/A","customerAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711737000,"product":"ALENDRONATE SODIUM TRIHYDRATE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"280","totalValueFC":"15595.7","currency":"EUR","unitRateINR":"25900","date":"30-Mar-2024","totalValueINR":"1295000","totalValueInUsd":"15595.7","indian_port":"Bombay Air","hs_no":"29319090","bill_no":"2813174","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"PELPLINSKA 19 83-200 STAROGARD GDANSKI Gdansk, , PolandSDNF Poland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712946600,"product":"CHEMICAL : SODIUM ALENDRONATE TRIHYDRATE","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"1.995","unit":"KGS","unitRateFc":"300","totalValueFC":"659.7","currency":"EUR","unitRateINR":"27615","date":"13-Apr-2024","totalValueINR":"55091.93","totalValueInUsd":"659.7","indian_port":"Ahmedabad Air","hs_no":"29223900","bill_no":"3003771","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"83-200 STAROGARD GDANSKI, UL. PELPLINSKA 19SDNF POLAND","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"ALENDRONATE SODIUM TRIHYDRATE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"280","totalValueFC":"23288.4","currency":"EUR","unitRateINR":"25956","date":"25-Jul-2024","totalValueINR":"1946700","totalValueInUsd":"23288.4","indian_port":"Bombay Air","hs_no":"29319090","bill_no":"4681895","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"PELPLINSKA 19 83-200 STAROGARD GDANSKI Gdansk, PolandSDNF Poland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]
29-Jan-2021
28-Sep-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)
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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

Alendronate Sodium

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 70MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

Octavius Pharma

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : DMF Available|FDF Compliance-U...

Alendronate Sodium

Dosage : DC Granules

Dosage Strength : 70MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

02

Pharmathen SA

Greece
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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Alendronate Sodium; Vitamin D3

Brand Name :

Dosage Form : Tablet

Dosage Strength : 70MG; 2800IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

02

Pharmathen SA

Greece
arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : EU Approved

Alendronate Sodium; Vitamin D3

Dosage : Tablet

Dosage Strength : 70MG; 2800IU

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

03

Pharmathen SA

Greece
arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Alendronate Sodium; Vitamin D3

Brand Name :

Dosage Form : Tablet

Dosage Strength : 70MG; 5600IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

03

Pharmathen SA

Greece
arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : EU Approved

Alendronate Sodium; Vitamin D3

Dosage : Tablet

Dosage Strength : 70MG; 5600IU

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Alendronate Sodium Trihydrate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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04

AAPS 2024
Not Confirmed
arrow
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AAPS 2024
Not Confirmed

Alendronate Sodium Trihydrate

Dosage : Tablet

Dosage Strength : 70MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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05

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Alendronate Sodium

Brand Name :

Dosage Form : TABLET

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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05

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Alendronate Sodium

Dosage : TABLET

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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06

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Alendronate Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

AAPS 2024
Not Confirmed
arrow
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AAPS 2024
Not Confirmed

Alendronate Sodium

Dosage : Tablet

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

07

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Alendronate Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

07

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Alendronate Sodium

Dosage : Tablet

Dosage Strength : 70MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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08

MS Pharma

Jordan
AAPS 2024
Not Confirmed
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MS Pharma

Jordan
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AAPS 2024
Not Confirmed

Fosamax

Brand Name :

Dosage Form : TABLET

Dosage Strength : 70MG

Packaging : Pack Size in UPM - 4

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Jordan

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08

MS Pharma

Jordan
AAPS 2024
Not Confirmed
arrow

MS Pharma

Jordan
arrow
AAPS 2024
Not Confirmed

Fosamax

Dosage : TABLET

Dosage Strength : 70MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Jordan

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Alendronate Sodium; Cholecalciferol

Brand Name : Bonpil Plus D

Dosage Form : TABLET

Dosage Strength : 91.37MG; 53.33MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic B.E study

Registration Country : South Korea

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Alendronate Sodium; Cholecalciferol

Dosage : TABLET

Dosage Strength : 91.37MG; 53.33MG

Brand Name : Bonpil Plus D

Approval Date :

Application Number :

Registration Country : South Korea

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Alendronate Sodium Trihydrate

Brand Name :

Dosage Form : DC Granules and Tablet...

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

AAPS 2024
Not Confirmed
arrow
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AAPS 2024
Not Confirmed

Alendronate Sodium Trihydrate

Dosage : DC Granules and Tablet...

Dosage Strength : 40MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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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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