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Chemistry

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Also known as: 8000-10-0, Sodium theophylline glycinate, Pemophyllin, Asbron, Bronchoparat, Glytheonate
Molecular Formula
C9H12N5NaO4
Molecular Weight
277.21  g/mol
InChI Key
AIJQWRAOMFRHTQ-UHFFFAOYSA-M
FDA UNII
2S36N8T753

Theophylline Sodium Glycinate
A methyl xanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Theophylline inhibits the 3',5'-CYCLIC NUCLEOTIDE PHOSPHODIESTERASE that degrades CYCLIC AMP thus potentiates the actions of agents that act through ADENYLYL CYCLASES and cyclic AMP.
1 2D Structure

Theophylline Sodium Glycinate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-aminoacetate;1,3-dimethyl-7H-purine-2,6-dione
2.1.2 InChI
InChI=1S/C7H8N4O2.C2H5NO2.Na/c1-10-5-4(8-3-9-5)6(12)11(2)7(10)13;3-1-2(4)5;/h3H,1-2H3,(H,8,9);1,3H2,(H,4,5);/q;;+1/p-1
2.1.3 InChI Key
AIJQWRAOMFRHTQ-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CN1C2=C(C(=O)N(C1=O)C)NC=N2.C(C(=O)[O-])N.[Na+]
2.2 Other Identifiers
2.2.1 UNII
2S36N8T753
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1,3 Dimethylxanthine

2. 1,3-dimethylxanthine

3. 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione

4. Accurbron

5. Aerobin

6. Aerolate

7. Afonilum Retard

8. Anhydrous, Theophylline

9. Aquaphyllin

10. Armophylline

11. Bronchoparat

12. Bronkodyl

13. Constant T

14. Constant-t

15. Constantt

16. Ct, Theo Von

17. Elixophyllin

18. Euphylong

19. Glycinate, Theophylline Sodium

20. Glycine Theophyllinate

21. Lodrane

22. Monospan

23. Nuelin

24. Nuelin S.a.

25. Quibron T Sr

26. Quibron T-sr

27. Quibron Tsr

28. Slo Phyllin

29. Slo-phyllin

30. Slophyllin

31. Sodium Glycinate, Theophylline

32. Somophyllin T

33. Somophyllin-t

34. Somophyllint

35. Sustaire

36. Synophylate

37. Theo 24

38. Theo Dur

39. Theo Von Ct

40. Theo-24

41. Theo-dur

42. Theo24

43. Theobid

44. Theocin

45. Theoconfin Continuous

46. Theodur

47. Theolair

48. Theolix

49. Theon

50. Theonite

51. Theopek

52. Theophyllinate, Glycine

53. Theophylline

54. Theophylline Anhydrous

55. Theospan

56. Theostat

57. Theovent

58. Uniphyl

59. Uniphyllin

60. Uniphylline

61. Von Ct, Theo

2.3.2 Depositor-Supplied Synonyms

1. 8000-10-0

2. Sodium Theophylline Glycinate

3. Pemophyllin

4. Asbron

5. Bronchoparat

6. Glytheonate

7. Panophylline

8. Englate

9. Theonate Sodium

10. Glycin Theophyllinate

11. Sodium;2-aminoacetate;1,3-dimethyl-7h-purine-2,6-dione

12. Theophylline Sodium Glycinate [usp]

13. 2s36n8t753

14. 10092-68-9

15. Glycine, Mixt. With 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione, Monosodium Salt

16. Theophylline Sodium Glycinate (usp)

17. Bronchoparat; Englate; Glycin Theophyllinate; Glytheonate; Panophylline; Pemophyllin

18. Glycine, Sodium Salt, Compd. With Theophylline

19. Theophylline Sodium Mixture With Glycine

20. Unii-2s36n8t753

21. Asbron (tn)

22. Schembl122089

23. Chembl1200578

24. Dtxsid60905845

25. Theophylline Sodium Aminoacetate

26. Theophylline Sodium Glycinate [mi]

27. Theophylline Sodium Glycinate [vandf]

28. D06104

29. Theophylline Sodium Aminoacetate [who-dd]

30. Theophylline Sodium Glycinate [orange Book]

31. Theophylline Sodium Glycinate [usp Monograph]

32. Q27255528

33. Glycine, Mixt. With 3,9-dihydro-1,3-dimethyl-1h-purine-2,6-dione Sodium Salt (1:1)

34. Sodium Aminoacetate--1,3-dimethyl-3,9-dihydro-1h-purine-2,6-dione (1/1/1)

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 277.21 g/mol
Molecular Formula C9H12N5NaO4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count1
Exact Mass277.07869816 g/mol
Monoisotopic Mass277.07869816 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count19
Formal Charge0
Complexity314
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


Purinergic P1 Receptor Antagonists

Compounds that bind to and block the stimulation of PURINERGIC P1 RECEPTORS. (See all compounds classified as Purinergic P1 Receptor Antagonists.)


Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


EU WC

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Theophylline Sodium Glycinate USP

Date of Issue : 2021-06-14

Valid Till : 2024-06-13

Written Confirmation Number : WC-0277

Address of the Firm : Unit -2, Block No.588, Savli Karachia Road, At & Post- Gothada, Dist Vadodara, G...

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Listed Suppliers

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Bakul Group

India
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Bakul Group

India
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Theophylline Sodium Glycinate

About the Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (APIs), Intermediates, ...

The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (APIs), Intermediates, and Speciality Chemicals. Since our inception in 1975, we have grown to become world leaders in the area of xanthine chemistry. They specialize in manufacturing APIs such as Linagliptin, Pentoxifylline, Theobromine, Doxofylline, Caffeine, Pamabrom, and others.
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FDF Dossiers

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THEOPHYLLINE SODIUM GLYCINATE

Brand Name : ASBRON

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 1982-01-01

Application Number : 85148

Regulatory Info : DISCN

Registration Country : USA

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euroPLX 87
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THEOPHYLLINE SODIUM GLYCINATE

Brand Name : SYNOPHYLATE

Dosage Form : ELIXIR;ORAL

Dosage Strength : EQ 165MG BASE/15ML

Packaging :

Approval Date : 1982-01-01

Application Number : 6333

Regulatory Info : DISCN

Registration Country : USA

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FDA Orange Book

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NOVARTIS

Switzerland
euroPLX 87
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NOVARTIS

Switzerland
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euroPLX 87
Not Confirmed

THEOPHYLLINE SODIUM GLYCINATE

Brand Name : ASBRON

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 1982-01-01

Application Number : 85148

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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CENT PHARMS

Country
euroPLX 87
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CENT PHARMS

Country
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euroPLX 87
Not Confirmed

THEOPHYLLINE SODIUM GLYCINATE

Brand Name : SYNOPHYLATE

Dosage Form : ELIXIR;ORAL

Dosage Strength : EQ 165MG BASE/15ML

Approval Date : 1982-01-01

Application Number : 6333

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Global Sales Information

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US Medicaid Prescriptions

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Organic Process R&D
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Company :

Theophylline Anhydrous

Drug Cost (USD) : 20,637

Year : 2022

Prescribers :

Prescriptions : 25

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Company :

Theophylline Anhydrous

Drug Cost (USD) : 7,105,374

Year : 2022

Prescribers : 5444

Prescriptions : 24820

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Company :

Theophylline Anhydrous

Drug Cost (USD) : 51,100

Year : 2021

Prescribers : 14

Prescriptions : 55

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Not Confirmed
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Company :

Theophylline Anhydrous

Drug Cost (USD) : 7,544,987

Year : 2021

Prescribers : 6200

Prescriptions : 29380

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Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Company :

Theophylline Anhydrous

Drug Cost (USD) : 97,672

Year : 2020

Prescribers : 22

Prescriptions : 79

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Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Company :

Theophylline Anhydrous

Drug Cost (USD) : 7,642,696

Year : 2020

Prescribers : 7115

Prescriptions : 33923

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Theophylline Sodium Glycinate manufacturers, exporters & distributors 1

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API | Excipient name

Theophylline Sodium Glycinate

Synonyms

8000-10-0, Sodium theophylline glycinate, Pemophyllin, Asbron, Bronchoparat, Glytheonate

Cas Number

8000-10-0

Unique Ingredient Identifier (UNII)

2S36N8T753

About Theophylline Sodium Glycinate

A methyl xanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Theophylline inhibits the 3',5'-CYCLIC NUCLEOTIDE PHOSPHODIESTERASE that degrades CYCLIC AMP thus potentiates the actions of agents that act through ADENYLYL CYCLASES and cyclic AMP.

Synophylate Manufacturers

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

Synophylate Suppliers

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

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Synophylate USDMF

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

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

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Synophylate WC

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

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Synophylate GMP

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

Synophylate CoA

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

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

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