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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
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Regulatory Info :
Registration Country : Italy
Brand Name : Alendr
Dosage Form : Alendronic Acid 10Mg 14 Joined' Oral Use
Dosage Strength : 14 CPR 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Alendronat Arrow
Dosage Form : Antic-calc Tablet
Dosage Strength : 70 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fosamax
Dosage Form : Antic-calc Tablet
Dosage Strength : 10 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fosamax
Dosage Form : Antic-calc Tablet
Dosage Strength : 70 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Alendronate Teva Veckotablett
Dosage Form : TABLET
Dosage Strength : 70 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Alendronate
Dosage Form : Alendronic Acid 70Mg 4 Units' Oral Use
Dosage Strength : 4 CPR 70 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Adronat
Dosage Form : Alendronic Acid 10Mg 14 Joined' Oral Use
Dosage Strength : 14 CPR 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Regulatory Info :
Registration Country : Spain
Brand Name : Korhispana Weekly Alendronico Acid 70Mg 4 Co Efg
Dosage Form : Tablet
Dosage Strength : 70 Mg/Tablet
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Application Number :
Regulatory Info :
Registration Country : Spain
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Registration Country : Spain
Brand Name : Ac Alendr Liderfarm 70Mg 4 Weekly Com Rec Pel Efg
Dosage Form : Tablet
Dosage Strength : 70 Mg/Tablet
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Regulatory Info :
Registration Country : Spain
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Brand Name : Weekly Fosamax 70Mg 4 Tablets
Dosage Form : Tablet
Dosage Strength : 70 Mg/Tablet
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Registration Country : Spain
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Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : ACH-ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging : 28
Approval Date :
Application Number : 2381478
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : APO-ALENDRONATE/VITAMIN D3
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 4
Approval Date :
Application Number : 2454467
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : APO-ALENDRONATE/VITAMIN D3
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 4
Approval Date :
Application Number : 2454475
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : AURO-ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 4/30/100/500/1000
Approval Date :
Application Number : 2388545
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : AURO-ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 4/30/100/500/1000
Approval Date :
Application Number : 2388553
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : M-ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number : 2529394
Regulatory Info :
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PMS-ALENDRONATE-FC
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 30
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Application Number :
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : PMS-ALENDRONATE-FC
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 30
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Application Number : 2284006
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : SANDOZ ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 4
Approval Date :
Application Number : 2288109
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Brand Name : ALENDRONATE
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : Apr-50
Approval Date :
Application Number : 2352966
Regulatory Info :
Registration Country : Canada
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ostena 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ostena 70
Dosage Form : TAB
Dosage Strength : 70mg
Packaging : 4X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Fosavance 5 600
Dosage Form : TAB
Dosage Strength : 70mg
Packaging : 4X1mg
Approval Date :
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Regulatory Info : Originator
Registration Country : South Africa
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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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ABOUT THIS PAGE
A Fosamax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamax, including repackagers and relabelers. The FDA regulates Fosamax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamax 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 Fosamax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosamax supplier is an individual or a company that provides Fosamax active pharmaceutical ingredient (API) or Fosamax finished formulations upon request. The Fosamax suppliers may include Fosamax API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosamax DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosamax active pharmaceutical ingredient (API) in detail. Different forms of Fosamax DMFs exist exist since differing nations have different regulations, such as Fosamax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosamax DMF submitted to regulatory agencies in the US is known as a USDMF. Fosamax USDMF includes data on Fosamax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosamax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosamax 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 Fosamax Drug Master File in Japan (Fosamax JDMF) empowers Fosamax 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 Fosamax JDMF during the approval evaluation for pharmaceutical products. At the time of Fosamax 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 Fosamax 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 Fosamax Drug Master File in Korea (Fosamax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosamax. The MFDS reviews the Fosamax KDMF as part of the drug registration process and uses the information provided in the Fosamax KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosamax 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 Fosamax API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosamax suppliers with KDMF on PharmaCompass.
A Fosamax CEP of the European Pharmacopoeia monograph is often referred to as a Fosamax Certificate of Suitability (COS). The purpose of a Fosamax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fosamax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fosamax to their clients by showing that a Fosamax CEP has been issued for it. The manufacturer submits a Fosamax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fosamax CEP holder for the record. Additionally, the data presented in the Fosamax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fosamax DMF.
A Fosamax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fosamax 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 Fosamax suppliers with CEP (COS) on PharmaCompass.
A Fosamax written confirmation (Fosamax WC) is an official document issued by a regulatory agency to a Fosamax manufacturer, verifying that the manufacturing facility of a Fosamax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fosamax APIs or Fosamax finished pharmaceutical products to another nation, regulatory agencies frequently require a Fosamax WC (written confirmation) as part of the regulatory process.
click here to find a list of Fosamax 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 Fosamax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosamax 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 Fosamax 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 Fosamax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosamax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosamax suppliers with NDC on PharmaCompass.
Fosamax 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 Fosamax 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 Fosamax GMP manufacturer or Fosamax GMP API supplier for your needs.
A Fosamax CoA (Certificate of Analysis) is a formal document that attests to Fosamax's compliance with Fosamax specifications and serves as a tool for batch-level quality control.
Fosamax CoA mostly includes findings from lab analyses of a specific batch. For each Fosamax 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.
Fosamax may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosamax EP), Fosamax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosamax USP).
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