Synopsis
Synopsis
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
EDQM
0
USP
0
JP
0
Others
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
NA
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FDF
0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz


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

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

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
Certificate Number : R1-CEP 2006-047 - Rev 03
Issue Date : 2021-01-22
Type : TSE
Substance Number :
Status : Valid

Certificate Number : R0-CEP 2001-132 - Rev 00
Issue Date : 2001-12-20
Type : TSE
Substance Number :
Status : Withdrawn by Holder

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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
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Ossein Hydroxyapatite Compound
Certificate Number : R1-CEP 2006-047 - Rev 03
Status : Valid
Issue Date : 2021-01-22
Type : TSE
Substance Number :

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Ossein Hydroxyapatite Compound
Certificate Number : R1-CEP 2001-133 - Rev 01
Status : Valid
Issue Date : 2014-01-10
Type : TSE
Substance Number :

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MicroCrystalline Hydroxyapatite Compound
Certificate Number : R0-CEP 2001-132 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-12-20
Type : TSE
Substance Number :

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Details:
HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Carbohydrate
Sponsor: Milton M. Hom
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2010
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Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Milton M. Hom
Deal Size : Inapplicable
Deal Type : Inapplicable
Tear Osmolarity Over Time With Artificial Tears
Details : HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.
Product Name : Undisclosed
Product Type : Carbohydrate
Upfront Cash : Inapplicable
October 25, 2010
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Allergan Aesthetics looks to further develop the Hybrid Injectables category by introducing its first dual-effect product, which combines the two active ingredients - hyaluronic acid, a well-known ingredient found in facial fillers and calcium hydroxyapatite in one injection.
Lead Product(s): Hyaluronic Acid,HYDROXYPROPYLMETHYLCELLULOSE
Therapeutic Area: Dermatology Brand Name: Juvederm Volux XC
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2022
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Lead Product(s) : Hyaluronic Acid,HYDROXYPROPYLMETHYLCELLULOSE
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Allergan Aesthetics looks to further develop the Hybrid Injectables category by introducing its first dual-effect product, which combines the two active ingredients - hyaluronic acid, a well-known ingredient found in facial fillers and calcium hydroxyapa...
Product Name : Juvederm Volux XC
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 29, 2022
Details:
Hydroxyapatite is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Molar Incisor Hypomineralisation.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Dental and Oral Health Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2025

Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Dental and Oral Health
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Hydroxyapatite vs Fluoride Toothpaste for MIH Remineralization
Details : Hydroxyapatite is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Molar Incisor Hypomineralisation.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 16, 2025

Details:
HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Non-Lipid Artificial Tear
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Carbohydrate
Sponsor: Alcon Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 20, 2025

Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Non-Lipid Artificial Tear
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Alcon Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Immediate Effects of Lipid-Based and Non-Lipid Artificial Tears on Corneal Aberrations
Details : HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Carbohydrate
Upfront Cash : Inapplicable
January 20, 2025

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OcuMension will acquire outright, Tears Natural Forte, Bion Tears, Alcaine, Fluorescite, and Cyclogyl, in the Chinese market and AR-15512, a novel topical drug candidate for dry eye.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Dextrans,Glycerine
Therapeutic Area: Ophthalmology Brand Name: Tears Naturale Forte
Study Phase: Approved FDFProduct Type: Carbohydrate
Sponsor: OcuMension Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 12, 2024

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Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Dextrans,Glycerine
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : OcuMension Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
OcuMension Acquires Alcon Eye Drops with 16.7% Equity, Strategic Partnership Begins
Details : OcuMension will acquire outright, Tears Natural Forte, Bion Tears, Alcaine, Fluorescite, and Cyclogyl, in the Chinese market and AR-15512, a novel topical drug candidate for dry eye.
Product Name : Tears Naturale Forte
Product Type : Carbohydrate
Upfront Cash : Undisclosed
August 12, 2024

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Calcium Hydroxyapatite is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Cellulite.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Kalpna Kay Durairaj
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2023

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Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Kalpna Kay Durairaj
Deal Size : Inapplicable
Deal Type : Inapplicable
Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Details : Calcium Hydroxyapatite is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Cellulite.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 01, 2023

Details:
Calcium Hydroxylapatite is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Incobotulinumtoxin A,Hyaluronic Acid
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Undisclosed
Sponsor: Merz Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 10, 2021

Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Incobotulinumtoxin A,Hyaluronic Acid
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merz Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational
Details : Calcium Hydroxylapatite is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
September 10, 2021

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Allergan Aesthetics will acquire Luminera's full dermal filler portfolio and R&D pipeline further enhancing Allergan Aesthetics' leading dermal filler portfolio with its JUVÉDERM® collection of fillers.
Lead Product(s): Hyaluronic Acid,HYDROXYPROPYLMETHYLCELLULOSE
Therapeutic Area: Dermatology Brand Name: HArmonyCa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Innovative Luminera
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 07, 2020

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Lead Product(s) : Hyaluronic Acid,HYDROXYPROPYLMETHYLCELLULOSE
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Innovative Luminera
Deal Size : Undisclosed
Deal Type : Acquisition
Allergan Aesthetics, an AbbVie Company, Acquires Innovative Luminera Dermal Filler Business
Details : Allergan Aesthetics will acquire Luminera's full dermal filler portfolio and R&D pipeline further enhancing Allergan Aesthetics' leading dermal filler portfolio with its JUVÉDERM® collection of fillers.
Product Name : HArmonyCa
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 07, 2020

Details:
HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Carboxymethyl Cellulose
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Carbohydrate
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 20, 2011

Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Carboxymethyl Cellulose
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients
Details : HYDROXYPROPYLMETHYLCELLULOSE is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.
Product Name : Undisclosed
Product Type : Carbohydrate
Upfront Cash : Inapplicable
January 20, 2011

Details:
Calcium Hydroxyapatite is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Malar Deficiency.
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Undisclosed
Sponsor: Merz Aesthetics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2010

Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merz Aesthetics
Deal Size : Inapplicable
Deal Type : Inapplicable
Injectable Filler for Cheek Flattening
Details : Calcium Hydroxyapatite is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Malar Deficiency.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 21, 2010

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ABOUT THIS PAGE
50
PharmaCompass offers a list of HYDROXYPROPYLMETHYLCELLULOSE 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 HYDROXYPROPYLMETHYLCELLULOSE manufacturer or HYDROXYPROPYLMETHYLCELLULOSE supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred HYDROXYPROPYLMETHYLCELLULOSE manufacturer or HYDROXYPROPYLMETHYLCELLULOSE supplier.
PharmaCompass also assists you with knowing the HYDROXYPROPYLMETHYLCELLULOSE API Price utilized in the formulation of products. HYDROXYPROPYLMETHYLCELLULOSE API Price is not always fixed or binding as the HYDROXYPROPYLMETHYLCELLULOSE Price is obtained through a variety of data sources. The HYDROXYPROPYLMETHYLCELLULOSE Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Durapatite manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Durapatite, including repackagers and relabelers. The FDA regulates Durapatite manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Durapatite 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 Durapatite supplier is an individual or a company that provides Durapatite active pharmaceutical ingredient (API) or Durapatite finished formulations upon request. The Durapatite suppliers may include Durapatite API manufacturers, exporters, distributors and traders.
click here to find a list of Durapatite suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Durapatite DMF (Drug Master File) is a document detailing the whole manufacturing process of Durapatite active pharmaceutical ingredient (API) in detail. Different forms of Durapatite DMFs exist exist since differing nations have different regulations, such as Durapatite USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Durapatite DMF submitted to regulatory agencies in the US is known as a USDMF. Durapatite USDMF includes data on Durapatite's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Durapatite USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Durapatite CEP of the European Pharmacopoeia monograph is often referred to as a Durapatite Certificate of Suitability (COS). The purpose of a Durapatite CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Durapatite EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Durapatite to their clients by showing that a Durapatite CEP has been issued for it. The manufacturer submits a Durapatite CEP (COS) as part of the market authorization procedure, and it takes on the role of a Durapatite CEP holder for the record. Additionally, the data presented in the Durapatite CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Durapatite DMF.
A Durapatite CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Durapatite 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 Durapatite suppliers with CEP (COS) on PharmaCompass.
Durapatite 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 Durapatite 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 Durapatite GMP manufacturer or Durapatite GMP API supplier for your needs.
A Durapatite CoA (Certificate of Analysis) is a formal document that attests to Durapatite's compliance with Durapatite specifications and serves as a tool for batch-level quality control.
Durapatite CoA mostly includes findings from lab analyses of a specific batch. For each Durapatite 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.
Durapatite may be tested according to a variety of international standards, such as European Pharmacopoeia (Durapatite EP), Durapatite JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Durapatite USP).