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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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    13-Jan-2021
    27-Feb-2025
    KGS
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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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    ABOUT THIS PAGE

    Looking for 129318-43-0 / Alendronate Sodium API manufacturers, exporters & distributors?

    Alendronate Sodium manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Alendronate Sodium 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 Alendronate Sodium manufacturer or Alendronate Sodium supplier for your needs.

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

    API | Excipient name

    Alendronate Sodium

    Synonyms

    129318-43-0, Fosamax, Binosto, Fosamac, Onclast, Monosodium alendronate

    Cas Number

    129318-43-0

    Unique Ingredient Identifier (UNII)

    4988K7X26P

    About 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.

    Alendronate Manufacturers

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

    Alendronate Suppliers

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

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

    Alendronate USDMF

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

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

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

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

    Alendronate KDMF

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

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

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

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

    Alendronate CEP

    A Alendronate CEP of the European Pharmacopoeia monograph is often referred to as a Alendronate Certificate of Suitability (COS). The purpose of a Alendronate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alendronate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alendronate to their clients by showing that a Alendronate CEP has been issued for it. The manufacturer submits a Alendronate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alendronate CEP holder for the record. Additionally, the data presented in the Alendronate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alendronate DMF.

    A Alendronate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alendronate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Alendronate suppliers with CEP (COS) on PharmaCompass.

    Alendronate WC

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

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

    Alendronate 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 Alendronate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Alendronate GMP

    Alendronate 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 Alendronate 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 Alendronate GMP manufacturer or Alendronate GMP API supplier for your needs.

    Alendronate CoA

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

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

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