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
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
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
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 : 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
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
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 : 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
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
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
Ossein Hydroxyapatite Compound
Certificate Number : R1-CEP 2001-133 - Rev 01
Status : Valid
Issue Date : 2014-01-10
Type : TSE
Substance Number :
MicroCrystalline Hydroxyapatite Compound
Certificate Number : R0-CEP 2001-132 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-12-20
Type : TSE
Substance Number :
Ossein Hydroxyapatite Compound
Certificate Number : R1-CEP 2006-047 - Rev 03
Status : Valid
Issue Date : 2021-01-22
Type : TSE
Substance Number :
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: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2022
Lead Product(s) : Hyaluronic Acid,HYDROXYPROPYLMETHYLCELLULOSE
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
March 29, 2022
Details:
Undisclosed
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Non-Lipid Artificial Tear
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
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 : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 20, 2025
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: Other Small Molecule
Sponsor: OcuMension Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 08, 2024
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 : Other Small Molecule
Upfront Cash : Undisclosed
December 08, 2024
Details:
Undisclosed
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Merz Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2023
Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Merz Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Details : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 01, 2023
Details:
Undisclosed
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 : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
September 10, 2021
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: Other Small Molecule
Sponsor: Innovative Luminera
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 10, 2020
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 : Other Small Molecule
Upfront Cash : Undisclosed
July 10, 2020
Details:
Undisclosed
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Carboxymethyl Cellulose
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
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 : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 20, 2011
Details:
Undisclosed
Lead Product(s): HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Allergan
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2010
Lead Product(s) : HYDROXYPROPYLMETHYLCELLULOSE,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Allergan
Deal Size : Inapplicable
Deal Type : Inapplicable
Tear Osmolarity Over Time With Artificial Tears
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 25, 2010
Details:
Undisclosed
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 : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 21, 2010
Regulatory Info : Generic
Registration Country : South Korea
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
Regulatory Info : Generic
Registration Country : South Korea
Durapatite; Glycerol; Polyethylene Glycol Monostearate
Brand Name : EASY-DROP
Dosage Form : EYE DROP
Dosage Strength : 2MG/ML; 2MG/ML; 10MG/ML
Packaging : 15mL
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Regulatory Info : Generic
Registration Country : South Korea
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
Packaging : 15mL, 0.6mL,30ea
Regulatory Info : Generic
Dosage : EYE DROP
Dosage Strength : 3MG; 1MG
Brand Name : NUMAREN
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info : Generic
Registration Country : South Korea
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
Packaging : 15mL
Regulatory Info : Generic
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
Market Place
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09 Jan 2021
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04 Nov 2024
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 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).