Find HYDROXYPROPYLMETHYLCELLULOSE manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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JDMF

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EU WC

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KDMF

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NDC API

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VMF

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Listed Suppliers

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

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Canada

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US Medicaid

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Chemistry

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Also known as: Durapatite, 12167-74-7, Hydroxylapatite, Alveograf, Periograf, Calcium hydroxyapatite
Molecular Formula
Ca5HO13P3
Molecular Weight
502.3  g/mol
InChI Key
XYJRXVWERLGGKC-UHFFFAOYSA-D
FDA UNII
91D9GV0Z28

HYDROXYPROPYLMETHYLCELLULOSE
The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.
1 2D Structure

HYDROXYPROPYLMETHYLCELLULOSE

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
pentacalcium;hydroxide;triphosphate
2.1.2 InChI
InChI=1S/5Ca.3H3O4P.H2O/c;;;;;3*1-5(2,3)4;/h;;;;;3*(H3,1,2,3,4);1H2/q5*+2;;;;/p-10
2.1.3 InChI Key
XYJRXVWERLGGKC-UHFFFAOYSA-D
2.1.4 Canonical SMILES
[OH-].[O-]P(=O)([O-])[O-].[O-]P(=O)([O-])[O-].[O-]P(=O)([O-])[O-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2]
2.2 Other Identifiers
2.2.1 UNII
91D9GV0Z28
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 502.3 g/mol
Molecular Formula Ca5HO13P3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count13
Rotatable Bond Count0
Exact Mass501.675955 g/mol
Monoisotopic Mass501.675955 g/mol
Topological Polar Surface Area260 Ų
Heavy Atom Count21
Formal Charge0
Complexity36.8
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count9
4 Drug and Medication Information
4.1 Therapeutic Uses

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)


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Calcium [CS]; Cations, Divalent [CS]; Increased Coagulation Factor Activity [PE]; Blood Coagulation Factor [EPC]

API SUPPLIERS

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HOYA CORP

Japan

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HOYA CORP

Japan

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HOYA CORP

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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HOYA CORP

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Toagosei

Japan

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Toagosei

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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07

Hercules Pharmaceuticals

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hercules Pharmaceuticals

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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08

Bio-Rad Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Bio-Rad Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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09

Pierre Fabre

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pierre Fabre

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pierre Fabre

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pierre Fabre

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF

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Bio-rad Laboratories

India

USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9438

Submission : 1991-11-15

Status : Inactive

Type : II

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Hercules Inc

Netherlands

USDMF

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Hercules Inc

Netherlands
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19628

Submission : 2006-07-20

Status : Inactive

Type : II

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Hoya Corp

Japan

USDMF

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Hoya Corp

Japan
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10881

Submission : 1994-04-22

Status : Active

Type : II

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05

Toagosei Co Ltd

Japan

USDMF

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05

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11212

Submission : 1994-11-21

Status : Inactive

Type : II

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Asahi Optical Co Ltd

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USDMF

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Asahi Optical Co Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9283

Submission : 1991-08-13

Status : Inactive

Type : II

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Koken Co Ltd

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USDMF

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Koken Co Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11149

Submission : 1994-10-19

Status : Inactive

Type : II

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Bk Ladenburg Gmbh

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USDMF

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Bk Ladenburg Gmbh

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10238

Submission : 1993-04-14

Status : Inactive

Type : II

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CEP/COS

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Drugs in Development

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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

Abbvie Company Banner

01

AbbVie Inc

U.S.A
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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.

Product Name : Undisclosed

Product Type : Carbohydrate

Upfront Cash : Inapplicable

October 25, 2010

Abbvie Company Banner

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 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

Abbvie CB

02

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

Abbvie CB

Details:

Calcium Hydroxyapatite, a Vitamins/Minerals/Inorganic Salts product, shows promise in reducing wrinkles, addressing a key focus area in skincare.


Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable

Therapeutic Area: Dermatology Brand Name: Radiesse

Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 05, 2026

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PEGS Boston Summit
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PEGS Boston Summit
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Details : Calcium Hydroxyapatite, a Vitamins/Minerals/Inorganic Salts product, shows promise in reducing wrinkles, addressing a key focus area in skincare.

Product Name : Radiesse

Product Type : Vitamins/Minerals/Inorganic Salts

Upfront Cash : Inapplicable

May 05, 2026

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  • Development Update

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

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04

Dubai Health

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Dubai Health

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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

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  • Development Update

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

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05

University of Seville

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Not Confirmed

University of Seville

Country
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Not Confirmed

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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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.


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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Alcon Inc

U.S.A
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PEGS Boston Summit
Not Confirmed

Alcon Inc

U.S.A
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PEGS Boston Summit
Not Confirmed

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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Details:

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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07

Merz Pharma

Germany
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Not Confirmed

Merz Pharma

Germany
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Not Confirmed

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

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  • Development Update

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

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08

Main Line Center for Laser Surgery

Country
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Not Confirmed

Main Line Center for Laser Surgery

Country
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Not Confirmed

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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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.


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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09

Luminera

Israel
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Not Confirmed

Luminera

Israel
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Not Confirmed

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

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  • Development Update

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

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University of Campinas, Brazil

Country
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Not Confirmed

University of Campinas, Brazil

Country
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Not Confirmed

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

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Listed Dossiers

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01

Hanlim Pharmaceutical

South Korea
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Hanlim Pharmaceutical

South Korea
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Durapatite; Dextrans

Brand Name : NUMAREN

Dosage Form : EYE DROP

Dosage Strength : 3MG; 1MG

Packaging : 15mL, 0.6mL,30ea

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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Hanlim Pharmaceutical

South Korea
PEGS Boston Summit
Not Confirmed
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Hanlim Pharmaceutical

South Korea
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Not Confirmed

Durapatite; Dextrans

Dosage : EYE DROP

Dosage Strength : 3MG; 1MG

Brand Name : NUMAREN

Approval Date :

Application Number :

Registration Country : South Korea

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02

Hanlim Pharmaceutical

South Korea
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Hanlim Pharmaceutical

South Korea
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Not Confirmed

Durapatite; Glycerol; Polyethylene Glycol Monostearate

Brand Name : EASY-DROP

Dosage Form : EYE DROP

Dosage Strength : 2MG/ML; 2MG/ML; 10MG/M...

Packaging : 15mL

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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Hanlim Pharmaceutical

South Korea
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Hanlim Pharmaceutical

South Korea
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Not Confirmed

Durapatite; Glycerol; Polyethylene Glycol Monostearate

Dosage : EYE DROP

Dosage Strength : 2MG/ML; 2MG/ML; 10MG/M...

Brand Name : EASY-DROP

Approval Date :

Application Number :

Registration Country : South Korea

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Looking for 1306-06-5 / HYDROXYPROPYLMETHYLCELLULOSE API manufacturers, exporters & distributors?

HYDROXYPROPYLMETHYLCELLULOSE manufacturers, exporters & distributors 1

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PharmaCompass offers a list of HYDROXYPROPYLMETHYLCELLULOSE API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.

API | Excipient name

HYDROXYPROPYLMETHYLCELLULOSE

Synonyms

Durapatite, 12167-74-7, Hydroxylapatite, Alveograf, Periograf, Calcium hydroxyapatite

Cas Number

1306-06-5

Unique Ingredient Identifier (UNII)

91D9GV0Z28

About HYDROXYPROPYLMETHYLCELLULOSE

The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.

HYDROXYPROPYLMETHYLCELLULOSE Manufacturers

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.

HYDROXYPROPYLMETHYLCELLULOSE Suppliers

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, and COA related information on PharmaCompass.

HYDROXYPROPYLMETHYLCELLULOSE USDMF

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.

HYDROXYPROPYLMETHYLCELLULOSE CEP

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 GMP

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, and more, enabling you to easily find the right HYDROXYPROPYLMETHYLCELLULOSE GMP manufacturer or HYDROXYPROPYLMETHYLCELLULOSE GMP API supplier for your needs.

HYDROXYPROPYLMETHYLCELLULOSE CoA

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).

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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