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Chemistry

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Also known as: 69975-86-6, Doxophylline, Ansimar, Dioxyfilline, Ventax, Maxivent
Molecular Formula
C11H14N4O4
Molecular Weight
266.25  g/mol
InChI Key
HWXIGFIVGWUZAO-UHFFFAOYSA-N
FDA UNII
MPM23GMO7Z

Doxofylline
Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline. Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug. The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.
1 2D Structure

Doxofylline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione
2.1.2 InChI
InChI=1S/C11H14N4O4/c1-13-9-8(10(16)14(2)11(13)17)15(6-12-9)5-7-18-3-4-19-7/h6-7H,3-5H2,1-2H3
2.1.3 InChI Key
HWXIGFIVGWUZAO-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1C2=C(C(=O)N(C1=O)C)N(C=N2)CC3OCCO3
2.2 Other Identifiers
2.2.1 UNII
MPM23GMO7Z
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(7'-theophyllinemethyl)1,3-dioxolane

2. Doxophylline

3. Tmdo

2.3.2 Depositor-Supplied Synonyms

1. 69975-86-6

2. Doxophylline

3. Ansimar

4. Dioxyfilline

5. Ventax

6. Maxivent

7. Abc 12/3

8. Synasma

9. 7-(1,3-dioxolan-2-ylmethyl)theophylline

10. Mpm23gmo7z

11. Nsc-759645

12. Abc-12/3

13. 1h-purine-2,6-dione, 7-(1,3-dioxolan-2-ylmethyl)-3,7-dihydro-1,3-dimethyl-

14. 7-((1,3-dioxolan-2-yl)methyl)-1,3-dimethyl-1h-purine-2,6(3h,7h)-dione

15. Ncgc00159330-02

16. Dsstox_cid_2968

17. 7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione

18. Dsstox_rid_76810

19. Dsstox_gsid_22968

20. Doxofilina

21. Doxofyllinum

22. Doxofylline [usan:inn]

23. Doxofilina [inn-spanish]

24. Doxofyllinum [inn-latin]

25. 7-((1,3-dioxolan-2-yl)methyl)-1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione

26. Cas-69975-86-6

27. Sr-01000789760

28. Einecs 274-239-6

29. Unii-mpm23gmo7z

30. Brn 0561195

31. 2-(7'-theophyllinemethyl)-1,3-dioxolane

32. Doxofylline,(s)

33. Maxivent (tn)

34. 2-(7'-teofillinmetil)-1,3-diossolano [italian]

35. Mfcd00865218

36. 2-(7'-teofillinmetil)-1,3-diossolano

37. Doxofylline [mi]

38. Doxofylline [inn]

39. Doxofylline (usan/inn)

40. Doxofylline [usan]

41. Theophylline, 7-(1,3-dioxolan-2-ylmethyl)-

42. 1h-purine-2,6-dione, 3,7-dihydro-7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethyl-

43. 7-(1,3-dioxolon-2-ylmethyl)-1,2,3,6-tetrahydro-1,3-dimethyl-2,6-purindion

44. Doxofylline [mart.]

45. Schembl37963

46. Doxofylline [who-dd]

47. 5-26-14-00120 (beilstein Handbook Reference)

48. Mls001214637

49. Zinc3837

50. Chembl1527608

51. Dtxsid7022968

52. Chebi:94714

53. Doxofylline, >=98% (hplc)

54. 7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethyl-purine-2,6-dione

55. Hms2090e04

56. Hms2877p10

57. Hms3652h03

58. Hms3714m21

59. Hms3885b09

60. Pharmakon1600-01502358

61. Abc-1213

62. Bcp12155

63. Hy-b0004

64. Tox21 111577

65. Tox21_111577

66. Bbl012263

67. Do-309

68. Nsc759645

69. S4164

70. Stk735429

71. 7-(1,3-dioxolan-2-ylmethyl)-3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione

72. Akos005535592

73. Tox21_111577_1

74. Ac-3492

75. Ccg-213050

76. Cs-8019

77. Db09273

78. Ds-7424

79. Nsc 759645

80. Ncgc00159330-03

81. Ncgc00159330-04

82. Ncgc00159330-10

83. Bd164389

84. Smr000543614

85. D4302

86. Ft-0630792

87. Sw199176-2

88. D03898

89. D90272

90. Ab00828111-06

91. Ab00828111_07

92. Ab00828111_08

93. 975d866

94. A836720

95. L001990

96. Q425887

97. 7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethylxanthine

98. Sr-01000789760-2

99. Sr-01000789760-3

100. 7-(1,3-dioxolan-2-ylmethyl)-1,3-dimethyl-1h-purine-2,6-dione

101. Doxofylline, United States Pharmacopeia (usp) Reference Standard

102. 7-[(1,3-dioxolan-2-yl)methyl]-1,3-dimethyl-2,3,6,7-tetrahydro-1h-purine-2,6-dione

2.4 Create Date
2005-07-07
3 Chemical and Physical Properties
Molecular Weight 266.25 g/mol
Molecular Formula C11H14N4O4
XLogP3-0.9
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass266.10150494 g/mol
Monoisotopic Mass266.10150494 g/mol
Topological Polar Surface Area76.9 Ų
Heavy Atom Count19
Formal Charge0
Complexity398
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Indicated for the treatment of chronic obstructive pulmonary disease (COPD), bronchial asthma and pulmonary disease with spastic bronchial component.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Doxofylline is a methylxanthine bronchodilator with potent bronchodilator activity comparable to that of theophylline. In animal studies, doxofylline demonstrated to attenuate bronchoconstriction, inflammatory actions and the release of thromboxane A2 (TXA2) when challenged with platelet-activating factor. Doxofylline does not demonstrate direct inhibition of any histone deacetylase (HDAC) enzymes or known PDE enzyme isoforms and did not act as an antagonist at A2 or A2 receptors. The affinity for adenosine A1, A2A and A2B receptors are reported to be all higher than 100 M. It only displays an inhibitory action against PDE2A1 and antagonism at adenosine A(2A) at high concentrations. A study demonstrated that doxofylline interacts with 2-adrenoceptors to induce blood vessel relaxation and airway smooth muscle relaxation. In dog studies, doxofylline decreased airway responsiveness at a dose that did not affect heart rate and respiratory rate.


5.2 MeSH Pharmacological Classification

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)


Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)


Phosphodiesterase Inhibitors

Compounds which inhibit or antagonize the biosynthesis or actions of phosphodiesterases. (See all compounds classified as Phosphodiesterase Inhibitors.)


5.3 ATC Code

R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03D - Other systemic drugs for obstructive airway diseases

R03DA - Xanthines

R03DA11 - Doxofylline


5.4 Absorption, Distribution and Excretion

Absorption

After repeated administrations doxofylline reaches the steady-state in about 4 days. Following oral administration of 400 mg doxofylline twice daily for 5 days in adults with chronic bronchitis, the peak plasma concentrations (Cmax) at steady state ranged from 5.78 to 20.76 mcg/mL. The time to reach maximum concentration (Tmax) was 1.19 0.19 hours. The absolute bioavailability of doxofylline in healthy subjects was 63 25%.


Route of Elimination

Less than 4% of an orally administered dose is excreted unchanged in the urine due to extensive hepatic metabolism.


Volume of Distribution

Doxofylline demonstrates a short distribution phase following intravenous administration of 100 mg given in adults with chronic bronchitis. As methylxanthines are distributed to all body compartments, doxofylline may be detected in breast milk and placenta.


Clearance

Following oral administration of 400 mg doxofylline twice daily for 5 days, the total clearance was 555.2 180.6 mL/min.


5.5 Metabolism/Metabolites

Doxofylline is thought to undergo hepatic metabolism which accounts for 90% of total drug clearance. -hydroxymethyltheophylline was detected in the serum and urine after oral administration of 400 mg given in healthy subjects. The circulating metabolite was devoid of any significant pharmacological activity.


5.6 Biological Half-Life

Following administration of a single intravenous dose of 100 mg over 10 minutes in adults with chronic bronchitis, the elimination half life of doxofylline was 1.83 0.37 hours. Following oral administration of 400 mg twice daily for 5 days in adults with chronic bronchitis, the mean elimination half life was 7.01 0.80 hours.


5.7 Mechanism of Action

The main mechanism of action of doxofylline is unclear. One of the mechanisms of action of is thought to arise from the inhibition of phosphodiesterase activity thus increasing the levels of cAMP and promoting smooth muscle relaxation. The interaction of doxofylline with beta-2 adrenoceptors was demonstrated by a study using nonlinear chromatography, frontal analysis and molecular docking. Serine 169 and serine 173 residues in the receptor are thought to be critical binding sites for doxofylline where hydrogen bonds are formed. Via mediating the actions of beta-2 adrenoceptors, doxofylline induces blood vessel relaxation and airway smooth muscle relaxation. There is also evidence that doxofylline may exert anti-inflammatory actions by reducing the pleurisy induced by the inflammatory mediator platelet activating factor (PAF) according to a rat study. It is suggested that doxofylline may play an important role in attenuating leukocyte diapedesis, supported by mouse preclinical studies where doxofylline administration was associated with inhibited leukocyte migration across vascular endothelial cells in vivo and in vitro.Unlike theophylline, doxofylline does not inhibit tumor necrosis factor-induced interleukin (IL)-8 secretion in ASM cells.


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Looking for 69975-86-6 / Doxofylline API manufacturers, exporters & distributors?

Doxofylline manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Doxofylline 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 Doxofylline manufacturer or Doxofylline supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxofylline manufacturer or Doxofylline supplier.

PharmaCompass also assists you with knowing the Doxofylline API Price utilized in the formulation of products. Doxofylline API Price is not always fixed or binding as the Doxofylline Price is obtained through a variety of data sources. The Doxofylline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Doxofylline

Synonyms

69975-86-6, Doxophylline, Ansimar, Dioxyfilline, Ventax, Maxivent

Cas Number

69975-86-6

Unique Ingredient Identifier (UNII)

MPM23GMO7Z

About Doxofylline

Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline. Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug. The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.

Doxofylline Manufacturers

A Doxofylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxofylline, including repackagers and relabelers. The FDA regulates Doxofylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxofylline 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 Doxofylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Doxofylline Suppliers

A Doxofylline supplier is an individual or a company that provides Doxofylline active pharmaceutical ingredient (API) or Doxofylline finished formulations upon request. The Doxofylline suppliers may include Doxofylline API manufacturers, exporters, distributors and traders.

click here to find a list of Doxofylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Doxofylline USDMF

A Doxofylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Doxofylline active pharmaceutical ingredient (API) in detail. Different forms of Doxofylline DMFs exist exist since differing nations have different regulations, such as Doxofylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Doxofylline DMF submitted to regulatory agencies in the US is known as a USDMF. Doxofylline USDMF includes data on Doxofylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doxofylline USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Doxofylline suppliers with USDMF on PharmaCompass.

Doxofylline KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Doxofylline Drug Master File in Korea (Doxofylline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Doxofylline. The MFDS reviews the Doxofylline KDMF as part of the drug registration process and uses the information provided in the Doxofylline KDMF to evaluate the safety and efficacy of the drug.

After submitting a Doxofylline 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 Doxofylline API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Doxofylline suppliers with KDMF on PharmaCompass.

Doxofylline WC

A Doxofylline written confirmation (Doxofylline WC) is an official document issued by a regulatory agency to a Doxofylline manufacturer, verifying that the manufacturing facility of a Doxofylline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Doxofylline APIs or Doxofylline finished pharmaceutical products to another nation, regulatory agencies frequently require a Doxofylline WC (written confirmation) as part of the regulatory process.

click here to find a list of Doxofylline suppliers with Written Confirmation (WC) on PharmaCompass.

Doxofylline NDC

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 Doxofylline as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Doxofylline API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Doxofylline 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Doxofylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Doxofylline NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Doxofylline suppliers with NDC on PharmaCompass.

Doxofylline GMP

Doxofylline 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 Doxofylline 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 Doxofylline GMP manufacturer or Doxofylline GMP API supplier for your needs.

Doxofylline CoA

A Doxofylline CoA (Certificate of Analysis) is a formal document that attests to Doxofylline's compliance with Doxofylline specifications and serves as a tool for batch-level quality control.

Doxofylline CoA mostly includes findings from lab analyses of a specific batch. For each Doxofylline 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.

Doxofylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Doxofylline EP), Doxofylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doxofylline 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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