Synopsis
Synopsis
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CEP/COS
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JDMF
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
Annual Reports
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Regulatory FDF Prices
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API
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FDF
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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. 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
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)
Molecular Weight | 277.21 g/mol |
---|---|
Molecular Formula | C9H12N5NaO4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 1 |
Exact Mass | 277.07869816 g/mol |
Monoisotopic Mass | 277.07869816 g/mol |
Topological Polar Surface Area | 135 Ų |
Heavy Atom Count | 19 |
Formal Charge | 0 |
Complexity | 314 |
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 | 3 |
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.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18896
Submission : 2005-10-17
Status : Inactive
Type : II
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...
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, ...
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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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RLD : No
TE Code :
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 :
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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Product Web Link
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Corporate PDF
Global Sales Information
Company :
Theophylline Anhydrous
Drug Cost (USD) : 20,637
Year : 2022
Prescribers :
Prescriptions : 25
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Theophylline Anhydrous
Drug Cost (USD) : 7,105,374
Year : 2022
Prescribers : 5444
Prescriptions : 24820
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Product Web Link
Virtual Booth
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Corporate PDF
Company :
Theophylline Anhydrous
Drug Cost (USD) : 51,100
Year : 2021
Prescribers : 14
Prescriptions : 55
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Corporate PDF
Company :
Theophylline Anhydrous
Drug Cost (USD) : 7,544,987
Year : 2021
Prescribers : 6200
Prescriptions : 29380
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Product Web Link
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Website
Corporate PDF
Company :
Theophylline Anhydrous
Drug Cost (USD) : 97,672
Year : 2020
Prescribers : 22
Prescriptions : 79
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Theophylline Anhydrous
Drug Cost (USD) : 7,642,696
Year : 2020
Prescribers : 7115
Prescriptions : 33923
Portfolio PDF
Product Web Link
Virtual Booth
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Website
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ABOUT THIS PAGE
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PharmaCompass offers a list of Theophylline Sodium Glycinate 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 Theophylline Sodium Glycinate manufacturer or Theophylline Sodium Glycinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Theophylline Sodium Glycinate manufacturer or Theophylline Sodium Glycinate supplier.
PharmaCompass also assists you with knowing the Theophylline Sodium Glycinate API Price utilized in the formulation of products. Theophylline Sodium Glycinate API Price is not always fixed or binding as the Theophylline Sodium Glycinate Price is obtained through a variety of data sources. The Theophylline Sodium Glycinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
click here to find a list of Synophylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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.
click here to find a list of Synophylate suppliers with USDMF on PharmaCompass.
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.
click here to find a list of Synophylate suppliers with Written Confirmation (WC) on PharmaCompass.
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.
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).