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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
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)
| Molecular Weight | 271.08 g/mol |
|---|---|
| Molecular Formula | C4H12NNaO7P2 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 5 |
| Exact Mass | 270.99867000 g/mol |
| Monoisotopic Mass | 270.99867000 g/mol |
| Topological Polar Surface Area | 164 Ų |
| Heavy Atom Count | 15 |
| Formal Charge | 0 |
| Complexity | 293 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 6 | |
|---|---|
| Drug Name | Alendronate sodium |
| PubMed Health | Alendronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | FOSAMAX1 (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | eq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml |
| Market Status | Prescription |
| Company | Watson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane |
| 2 of 6 | |
|---|---|
| Drug Name | Binosto |
| Drug Label | BINOSTO (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet, effervescent |
| Route | Oral |
| Strength | eq 70mg base |
| Market Status | Prescription |
| Company | Mission Pharma |
| 3 of 6 | |
|---|---|
| Drug Name | Fosamax |
| PubMed Health | Alendronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | FOSAMAX1 (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | eq 70mg base; eq 70mg base/75ml |
| Market Status | Prescription |
| Company | Merck; Merck And |
| 4 of 6 | |
|---|---|
| Drug Name | Alendronate sodium |
| PubMed Health | Alendronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | FOSAMAX1 (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | eq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml |
| Market Status | Prescription |
| Company | Watson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane |
| 5 of 6 | |
|---|---|
| Drug Name | Binosto |
| Drug Label | BINOSTO (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet, effervescent |
| Route | Oral |
| Strength | eq 70mg base |
| Market Status | Prescription |
| Company | Mission Pharma |
| 6 of 6 | |
|---|---|
| Drug Name | Fosamax |
| PubMed Health | Alendronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | FOSAMAX1 (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 Ingredient | Alendronate sodium |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | eq 70mg base; eq 70mg base/75ml |
| Market Status | Prescription |
| Company | Merck; Merck And |
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.
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.)
M05BB03
M05BB03
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : R1-CEP 2003-273 - Rev 04
Status : Valid
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1564
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2004-215 - Rev 04
Status : Valid
Issue Date : 2019-01-04
Type : Chemical
Substance Number : 1564
Certificate Number : R0-CEP 2008-254 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2011-05-12
Type : Chemical
Substance Number : 1564
Certificate Number : R0-CEP 2009-288 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2013-09-18
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2005-126 - Rev 04
Status : Valid
Issue Date : 2018-08-29
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2006-189 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2013-01-29
Type : Chemical
Substance Number : 1564
Sodium Alendronate Trihydrate, Milled
Certificate Number : R1-CEP 2004-095 - Rev 04
Status : Valid
Issue Date : 2020-08-19
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2008-090 - Rev 02
Status : Valid
Issue Date : 2021-04-27
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2010-273 - Rev 00
Status : Valid
Issue Date : 2016-10-13
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2008-192 - Rev 01
Status : Valid
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 1564
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Sodium Alendronate (BP/EP/USP)
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 470748, 470749, GIDC,Industrial Estate, Ankleshwar, Dist.Bharuch-393...
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074Amended
Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India
Date of Issue : 2022-06-08
Valid Till : 2025-09-08
Written Confirmation Number : WC-0144nA2
Address of the Firm : D-7, MIDC, Industrial Area, Kurkumbh, Taluka: Daund, District: Pune -Zone4- 413 ...
Sodium Alendronate (BP/Ph.Eur)
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm : Sejavta, Ratlam, Madhya PradeshÂ
Alendronate Sodium Trihydrate (JP)
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-236
Address of the Firm : 4722,4723 & 4731, GIDC Estate, city: Ankleshwar, Dist: Bharuch, Gujrat
Date of Issue : 2022-09-01
Valid Till : 2024-11-04
Written Confirmation Number : WC-0092
Address of the Firm : Plot No. 18, 56, 57 & 58, K.I.A.D.B. Industrial Area\r\nNanjangud - 571 302, Mys...
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC, Industrial Zone, At & Post - Panoli, Dist....
Alendronate Sodium USP/Ph. Eur
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm : Unit VIII, G Chodevaram (V), Pusapatirega (Mandal), Vizianagaram Dist.,-535204, ...
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Drugs in Development
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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
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
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
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
DOSAGE - TABLET;ORAL - EQ 70MG BASE
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 70MG BASE;2,800 IU
USFDA APPLICATION NUMBER - 21762
DOSAGE - TABLET;ORAL - EQ 70MG BASE;5,600 IU
USFDA APPLICATION NUMBER - 21762
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alendronate Sodium manufacturer or Alendronate Sodium supplier.
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.
A SODIUM ALDENDRONATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SODIUM ALDENDRONATE, including repackagers and relabelers. The FDA regulates SODIUM ALDENDRONATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SODIUM ALDENDRONATE supplier is an individual or a company that provides SODIUM ALDENDRONATE active pharmaceutical ingredient (API) or SODIUM ALDENDRONATE finished formulations upon request. The SODIUM ALDENDRONATE suppliers may include SODIUM ALDENDRONATE API manufacturers, exporters, distributors and traders.
click here to find a list of SODIUM ALDENDRONATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SODIUM ALDENDRONATE DMF (Drug Master File) is a document detailing the whole manufacturing process of SODIUM ALDENDRONATE active pharmaceutical ingredient (API) in detail. Different forms of SODIUM ALDENDRONATE DMFs exist exist since differing nations have different regulations, such as SODIUM ALDENDRONATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SODIUM ALDENDRONATE DMF submitted to regulatory agencies in the US is known as a USDMF. SODIUM ALDENDRONATE USDMF includes data on SODIUM ALDENDRONATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SODIUM ALDENDRONATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SODIUM ALDENDRONATE suppliers with USDMF on PharmaCompass.
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 SODIUM ALDENDRONATE Drug Master File in Japan (SODIUM ALDENDRONATE JDMF) empowers SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE JDMF during the approval evaluation for pharmaceutical products. At the time of SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a SODIUM ALDENDRONATE Drug Master File in Korea (SODIUM ALDENDRONATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SODIUM ALDENDRONATE. The MFDS reviews the SODIUM ALDENDRONATE KDMF as part of the drug registration process and uses the information provided in the SODIUM ALDENDRONATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SODIUM ALDENDRONATE suppliers with KDMF on PharmaCompass.
A SODIUM ALDENDRONATE CEP of the European Pharmacopoeia monograph is often referred to as a SODIUM ALDENDRONATE Certificate of Suitability (COS). The purpose of a SODIUM ALDENDRONATE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SODIUM ALDENDRONATE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SODIUM ALDENDRONATE to their clients by showing that a SODIUM ALDENDRONATE CEP has been issued for it. The manufacturer submits a SODIUM ALDENDRONATE CEP (COS) as part of the market authorization procedure, and it takes on the role of a SODIUM ALDENDRONATE CEP holder for the record. Additionally, the data presented in the SODIUM ALDENDRONATE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SODIUM ALDENDRONATE DMF.
A SODIUM ALDENDRONATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE suppliers with CEP (COS) on PharmaCompass.
A SODIUM ALDENDRONATE written confirmation (SODIUM ALDENDRONATE WC) is an official document issued by a regulatory agency to a SODIUM ALDENDRONATE manufacturer, verifying that the manufacturing facility of a SODIUM ALDENDRONATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SODIUM ALDENDRONATE APIs or SODIUM ALDENDRONATE finished pharmaceutical products to another nation, regulatory agencies frequently require a SODIUM ALDENDRONATE WC (written confirmation) as part of the regulatory process.
click here to find a list of SODIUM ALDENDRONATE suppliers with Written Confirmation (WC) on PharmaCompass.
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 SODIUM ALDENDRONATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SODIUM ALDENDRONATE API and other APIs are published in this directory by the FDA.
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 SODIUM ALDENDRONATE 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.
The NDC directory also contains data on finished compounded human drug products that contain SODIUM ALDENDRONATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SODIUM ALDENDRONATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SODIUM ALDENDRONATE suppliers with NDC on PharmaCompass.
SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE GMP manufacturer or SODIUM ALDENDRONATE GMP API supplier for your needs.
A SODIUM ALDENDRONATE CoA (Certificate of Analysis) is a formal document that attests to SODIUM ALDENDRONATE's compliance with SODIUM ALDENDRONATE specifications and serves as a tool for batch-level quality control.
SODIUM ALDENDRONATE CoA mostly includes findings from lab analyses of a specific batch. For each SODIUM ALDENDRONATE 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.
SODIUM ALDENDRONATE may be tested according to a variety of international standards, such as European Pharmacopoeia (SODIUM ALDENDRONATE EP), SODIUM ALDENDRONATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SODIUM ALDENDRONATE USP).
