Synopsis
Synopsis
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1. Alveograf
2. Calcitite
3. Calcium Hydroxyapatite
4. Durapatite
5. Hydroxyapatite, Calcium
6. Hydroxylapatite
7. Interpore 200
8. Interpore 500
9. Interpore-200
10. Interpore-500
11. Interpore200
12. Interpore500
13. Osprovit
14. Ossein Hydroxyapatite Compound
15. Ossein-hydroxyapatite Compound
16. Ossopan
17. Osteogen
18. Periograf
1. Durapatite
2. 12167-74-7
3. Hydroxylapatite
4. Alveograf
5. Periograf
6. Calcium Hydroxyapatite
7. Radiesse
8. Tribasic Calcium Phosphate
9. Durapatite [usan]
10. Calcium Hydroxide Phosphate
11. Win 40350
12. Calcium Hydroxylapatite
13. Calcium Hydroxide Tris(phosphate)
14. Pentacalcium;hydroxide;triphosphate
15. Hydroxylapatite, Ceramic
16. Ossopan
17. Calcium Phosphate, Tribasic [nf]
18. 91d9gv0z28
19. Durapatite (usan)
20. Mfcd00010904
21. Win-40350
22. Apatite, Hydroxy
23. Supertite 10
24. Calcium Phosphate, Tribasic (nf)
25. Pentacalcium Hydroxide Triphosphate
26. Hydroxylapatite (ca5(oh)(po4)3)
27. Calcium Orthophosphate, Basic
28. Hsdb 5804
29. Dekacalcium-dihydrat-hexa(phosphat)
30. Calcium Tribasic Phosphate
31. Einecs 215-145-7
32. Pentacalcium Monohydroxyorthophosphate
33. Pentacalcium Hydroxide Tris(orthophosphate)
34. Unii-91d9gv0z28
35. Hydroxyl Apatite
36. Alveograf (tn)
37. Decacalcium Hexaphosphate Dihydroxide
38. Einecs 235-330-6
39. Durapatite [mi]
40. Microcrystalline Hydroxyapatite Concentrate
41. Hydroxyapatite Nanopowder
42. Hydroxyapatite Micronpowder
43. Hydroxylapatite, Fast Flow
44. Calcarea Phosphorica
45. Ec 235-330-6
46. Hydroxyapatite Nanoparticles
47. Durapatite [who-dd]
48. Calcium Hydroxide Phosphate (ca10(oh)2(po4)6)
49. Hydroxyapatite [inci]
50. Hydroxyapatite [mart.]
51. Chembl2218916
52. Calcium Phosphate,tribasic
53. Calcium Orthophosphates Nanopowder
54. Dtxsid50872537
55. Hydroxylapatite, (ca 35-40%)
56. Calcarea Phosphorica [hpus]
57. Calcium Phosphate [who-ip]
58. Calcium Phosphate (tribasic)
59. Calcium Hydroxyapatite [inci]
60. Hydroxyapatite Nanoparticles Dispersion
61. Calcii Phosphas [who-ip Latin]
62. Tribasic Calcium Phosphate [ii]
63. Calcium Phosphate,tribasic [vandf]
64. Db-041626
65. Tribasic Calcium Phosphate [usp-rs]
66. Tribasic Calcium Phosphate [who-ip]
67. Ft-0630391
68. D03303
69. D03922
70. Calcium Phosphate Tribasic 34 To 40% Calcium Basis
71. J-004582
72. J-005837
73. Q27271399
74. Hydroxyapatite Nanoparticles, 5-10% (w/v) Aqueous Colloidal Dispersion, 20-50nm Particles
75. Pentacalcium Hydroxide Tris(orthophosphate), With A Fluorine Content Of Less Than 0,005 % By Weight On The Dry Anhydrous Product
Molecular Weight | 502.3 g/mol |
---|---|
Molecular Formula | Ca5HO13P3 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 13 |
Rotatable Bond Count | 0 |
Exact Mass | 501.675955 g/mol |
Monoisotopic Mass | 501.675955 g/mol |
Topological Polar Surface Area | 260 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 36.8 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 9 |
EXPT USE: WOMEN WITH PRIMARY BILIARY CIRRHOSIS MALABSORB CALCIUM, PHOSPHATE & VITAMIN D, & DEVELOP ACCELERATED CORTICAL BONE THINNING. HYDROXYAPATITE WAS ASSESSED FOR ITS VALUE IN THE TREATMENT OF CORTICAL BONE THINNING IN PRIMARY BILIARY CIRRHOSIS. CORTICAL BONE LOSS OCCURRED IN THE CONTROL GROUP. THE HYDROXYAPATITE GROUP SHOWED A SIGNIFICANT GAIN IN CORTICAL BONE THICKNESS.
PMID:6287835 EPSTEIN O ET AL; AM J CLIN NUTR 36 (3): 426 (1982)
Biocompatible Materials
Synthetic or natural materials, other than DRUGS, that are used to replace or repair any body TISSUES or bodily function. (See all compounds classified as Biocompatible Materials.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10881
Submission : 1994-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10914
Submission : 1994-04-22
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9283
Submission : 1991-08-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10238
Submission : 1993-04-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11149
Submission : 1994-10-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11212
Submission : 1994-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19628
Submission : 2006-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9438
Submission : 1991-11-15
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-132 - Rev 00
Issue Date : 2001-12-20
Type : TSE
Substance Number :
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2001-133 - Rev 01
Issue Date : 2014-01-10
Type : TSE
Substance Number :
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9438
Submission : 1991-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19628
Submission : 2006-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10914
Submission : 1994-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10881
Submission : 1994-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11212
Submission : 1994-11-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11149
Submission : 1994-10-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10238
Submission : 1993-04-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9283
Submission : 1991-08-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
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ABOUT THIS PAGE
A HYDROXYPROPYLMETHYLCELLULOSE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HYDROXYPROPYLMETHYLCELLULOSE, including repackagers and relabelers. The FDA regulates HYDROXYPROPYLMETHYLCELLULOSE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HYDROXYPROPYLMETHYLCELLULOSE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A HYDROXYPROPYLMETHYLCELLULOSE supplier is an individual or a company that provides HYDROXYPROPYLMETHYLCELLULOSE active pharmaceutical ingredient (API) or HYDROXYPROPYLMETHYLCELLULOSE finished formulations upon request. The HYDROXYPROPYLMETHYLCELLULOSE suppliers may include HYDROXYPROPYLMETHYLCELLULOSE API manufacturers, exporters, distributors and traders.
click here to find a list of HYDROXYPROPYLMETHYLCELLULOSE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A HYDROXYPROPYLMETHYLCELLULOSE DMF (Drug Master File) is a document detailing the whole manufacturing process of HYDROXYPROPYLMETHYLCELLULOSE active pharmaceutical ingredient (API) in detail. Different forms of HYDROXYPROPYLMETHYLCELLULOSE DMFs exist exist since differing nations have different regulations, such as HYDROXYPROPYLMETHYLCELLULOSE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A HYDROXYPROPYLMETHYLCELLULOSE DMF submitted to regulatory agencies in the US is known as a USDMF. HYDROXYPROPYLMETHYLCELLULOSE USDMF includes data on HYDROXYPROPYLMETHYLCELLULOSE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The HYDROXYPROPYLMETHYLCELLULOSE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of HYDROXYPROPYLMETHYLCELLULOSE suppliers with USDMF on PharmaCompass.
A HYDROXYPROPYLMETHYLCELLULOSE CEP of the European Pharmacopoeia monograph is often referred to as a HYDROXYPROPYLMETHYLCELLULOSE Certificate of Suitability (COS). The purpose of a HYDROXYPROPYLMETHYLCELLULOSE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of HYDROXYPROPYLMETHYLCELLULOSE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of HYDROXYPROPYLMETHYLCELLULOSE to their clients by showing that a HYDROXYPROPYLMETHYLCELLULOSE CEP has been issued for it. The manufacturer submits a HYDROXYPROPYLMETHYLCELLULOSE CEP (COS) as part of the market authorization procedure, and it takes on the role of a HYDROXYPROPYLMETHYLCELLULOSE CEP holder for the record. Additionally, the data presented in the HYDROXYPROPYLMETHYLCELLULOSE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the HYDROXYPROPYLMETHYLCELLULOSE DMF.
A HYDROXYPROPYLMETHYLCELLULOSE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. HYDROXYPROPYLMETHYLCELLULOSE 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 HYDROXYPROPYLMETHYLCELLULOSE suppliers with CEP (COS) on PharmaCompass.
HYDROXYPROPYLMETHYLCELLULOSE 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 HYDROXYPROPYLMETHYLCELLULOSE 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 HYDROXYPROPYLMETHYLCELLULOSE GMP manufacturer or HYDROXYPROPYLMETHYLCELLULOSE GMP API supplier for your needs.
A HYDROXYPROPYLMETHYLCELLULOSE CoA (Certificate of Analysis) is a formal document that attests to HYDROXYPROPYLMETHYLCELLULOSE's compliance with HYDROXYPROPYLMETHYLCELLULOSE specifications and serves as a tool for batch-level quality control.
HYDROXYPROPYLMETHYLCELLULOSE CoA mostly includes findings from lab analyses of a specific batch. For each HYDROXYPROPYLMETHYLCELLULOSE 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.
HYDROXYPROPYLMETHYLCELLULOSE may be tested according to a variety of international standards, such as European Pharmacopoeia (HYDROXYPROPYLMETHYLCELLULOSE EP), HYDROXYPROPYLMETHYLCELLULOSE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (HYDROXYPROPYLMETHYLCELLULOSE USP).
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