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    Chemistry

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    Also known as: 317-34-0, Aminophyllin, Cardophyllin, Phyllocontin, Syntophyllin, Theophyllamine
    Molecular Formula
    C16H24N10O4
    Molecular Weight
    420.43  g/mol
    InChI Key
    FQPFAHBPWDRTLU-UHFFFAOYSA-N
    FDA UNII
    27Y3KJK423
    Aminophylline
    A drug combination that contains THEOPHYLLINE and ethylenediamine. It is more soluble in water than theophylline but has similar pharmacologic actions. It's most common use is in bronchial asthma, but it has been investigated for several other applications.
    1 2D Structure

    Aminophylline

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1,3-dimethyl-7H-purine-2,6-dione;ethane-1,2-diamine
    2.1.2 InChI
    InChI=1S/2C7H8N4O2.C2H8N2/c2*1-10-5-4(8-3-9-5)6(12)11(2)7(10)13;3-1-2-4/h2*3H,1-2H3,(H,8,9);1-4H2
    2.1.3 InChI Key
    FQPFAHBPWDRTLU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1C2=C(C(=O)N(C1=O)C)NC=N2.CN1C2=C(C(=O)N(C1=O)C)NC=N2.C(CN)N
    2.2 Other Identifiers
    2.2.1 UNII
    27Y3KJK423
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Afonilum

    2. Aminodur

    3. Aminophyllin

    4. Aminophylline Df

    5. Cardophyllin

    6. Carine

    7. Clonofilin

    8. Corophyllin

    9. Diaphyllin

    10. Drafilyn

    11. Duraphyllin

    12. Ethylenediamine, Theophylline

    13. Eufilina

    14. Eufilina Venosa

    15. Euphyllin

    16. Euphyllin Retard

    17. Euphylline

    18. Godafilin

    19. Mini-lix

    20. Mundiphyllin

    21. Mundiphyllin Retard

    22. Novophyllin

    23. Phyllocontin

    24. Phyllotemp

    25. Somophyllin

    26. Tari-dog

    27. Theophyllamin Jenapharm

    28. Theophyllamine

    29. Theophyllin Eda Ratiopharm

    30. Theophyllin Eda-ratiopharm

    31. Theophyllin Edaratiopharm

    32. Theophylline Ethylenediamine

    33. Truphylline

    2.3.2 Depositor-Supplied Synonyms

    1. 317-34-0

    2. Aminophyllin

    3. Cardophyllin

    4. Phyllocontin

    5. Syntophyllin

    6. Theophyllamine

    7. Linampheta

    8. Somophyllin

    9. Truphylline

    10. Theophylline Ethylenediamine

    11. Aminodur

    12. Aminocardol

    13. Cardiofilina

    14. Cardophylin

    15. Diaphylline

    16. Diuxanthine

    17. Ethophylline

    18. Eurphyllin

    19. Genophyllin

    20. Inophylline

    21. Metaphyllin

    22. Metaphylline

    23. Methophylline

    24. Neophyiline

    25. Norofilina

    26. Peterphyllin

    27. Phylcardin

    28. Phyllindon

    29. Stenovasan

    30. Theolamine

    31. Theophyldine

    32. Theophyllaminum

    33. Thephyldine

    34. Variaphylline

    35. Vasofilina

    36. Cardiomin

    37. Cariomin

    38. Diophllin

    39. Euufillin

    40. Grifomin

    41. Lasodex

    42. Lixaminol

    43. Minaphil

    44. Miofilin

    45. Theodrox

    46. Theolone

    47. Carena

    48. Aminophyllinum

    49. Diaphilline

    50. Diophyllin

    51. Eufilina

    52. Euphyllin

    53. Euphylline

    54. Euphyllinum

    55. Euufilin

    56. Theomin

    57. Theophyllaminium

    58. Dobo

    59. Rectalad Aminophylline

    60. Theophyline Ethylenediamine

    61. Aminodur Dura-tabs

    62. Theophyllin Aethylendiamin

    63. Ammophyllin

    64. Tefamin

    65. Aminofilina

    66. Aminofillina

    67. Somophyllin O

    68. Aminophylline Ethylenediamine

    69. Rectalad-aminophylline

    70. Theophyllin Ethylenediamine

    71. Dura-tab S.m. Aminophylline

    72. Etilen-xantisan Tabl.

    73. By 108

    74. Th/100

    75. 1h-purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, Compd. With 1,2-ethanediamine (2:1)

    76. Theophylline Compound With Ethylenediamine

    77. Theophylline, Compd With Ethylenediamine (2:1)

    78. Ethylenediamine, Compd. With Theophylline (1:2)

    79. Theophylline-ethylenediamine Anhydrous

    80. Theophylline Compound With Ethylenediamine (2:1)

    81. Aminophylline (truphylline)

    82. Theophylline-ethylenediamine

    83. 27y3kjk423

    84. Nsc-7919

    85. Theophylline, Compd. With Ethylenediamine (2:1)

    86. Aminophylline Anhydrous

    87. Aminophylline Dye Free

    88. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione Compound With Ethane-1,2-diamine (2:1)

    89. Eufilina [polish]

    90. Aminofillina [dcit]

    91. Aminofilina [spanish]

    92. Somopphyllin

    93. Dura-tab Sm Aminophylline

    94. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione Hemiethane-1,2-diamine Salt

    95. Aminofilina [inn-spanish]

    96. Aminophyllinum [inn-latin]

    97. Pulmophyllin (new)

    98. Mudrane Gg Tablets

    99. Pulmophylline (new)

    100. Hsdb 221

    101. Theophyllinum Et Ethylendiaminum

    102. Mudrane Gg-2 Tablets

    103. Theophyllin Aethylendiamin [german]

    104. Nsc 7919

    105. Einecs 206-264-5

    106. Unii-27y3kjk423

    107. Etilen-xantisan

    108. Aminophylline In Sodium Chloride 0.45%

    109. Prestwick_93

    110. Somophyllin (tn)

    111. Aminophylline [usp:inn:ban:jan]

    112. Mfcd00013221

    113. 1,3-dimethyl-7h-purine-2,6-dione; Ethane-1,2-diamine

    114. Ammonium Carbonate Nf

    115. Aminophylline, Anhydrous

    116. Aminophylline In Sodium Chloride 0.45% In Plastic Container

    117. Lopac-a-1755

    118. Aminophylline (usp/inn)

    119. Aminophylline [mi]

    120. Aminophylline [inn]

    121. Schembl5037

    122. 1h-purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, Compd With 1,2-ethanediamine (2:1)

    123. 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione Compd. With 1,2-ethanediamine (2:1)

    124. Aminophylline [hsdb]

    125. Aminophylline [inci]

    126. Aminophylline [vandf]

    127. Aminophylline [mart.]

    128. Aminophylline Anhydrous Powder

    129. Aminophylline [who-dd]

    130. Aminophylline [who-ip]

    131. Chebi:2659

    132. Aminophylline, >=98%, Powder

    133. Chembl1370561

    134. Dtxsid40883359

    135. Theophylline Ethylenediamine (tn)

    136. Hms1570d21

    137. Hms2097d21

    138. Hms3260c09

    139. Hms3655a19

    140. Hms3714d21

    141. Hms3884g06

    142. Aminophylline [orange Book]

    143. Bcp23387

    144. Hy-b0140

    145. Tox21_500014

    146. Aminophylline [usp Monograph]

    147. S1673

    148. Aminophyllinum [who-ip Latin]

    149. Akos015951253

    150. Akos015960458

    151. Theophylline And Ethylenediamine

    152. Bcp9000293

    153. Ccg-220820

    154. Ccg-221318

    155. Cs-1936

    156. Db01223

    157. Ks-5340

    158. Lp00014

    159. Aminophylline(phyllocontin, Truphylline)

    160. Ncgc00016113-01

    161. Ncgc00016113-02

    162. Ncgc00016113-03

    163. Ncgc00093539-01

    164. Ncgc00260699-01

    165. 95646-60-9

    166. Ac-11138

    167. Ba166016

    168. Cas-317-34-0

    169. Bcp0726000247

    170. A2805

    171. Eu-0100014

    172. Ft-0622295

    173. Sw199286-2

    174. A 1755

    175. D00227

    176. I10006

    177. A875823

    178. Q471763

    179. Sr-01000872628

    180. Theophylline-ethylenediamine [ep Monograph]

    181. Sr-01000872628-1

    182. W-106881

    183. Theophylline-ethylenediamine Anhydrous [ep Impurity]

    184. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dionehemiethane-1,2-diaminesalt

    185. 1,2-ethanediamine, Compd. With 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione (1:2)

    186. 1,3-dimethyl-1h-purine-2,6(3h,7h)-dione Compound With Ethane-1,2-diamine (2:1)

    187. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione - Ethane-1,2-diamine (2:1)

    188. 1,3-dimethyl-3,9-dihydro-1h-purine-2,6-dione Compound With Ethane-1,2-diamine (2:1)

    189. 1h-purine-2,6-dione, 3,9-dihydro-1,3-dimethyl-, Compd. With 1,2-ethanediamine (2:1)

    190. 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione, Compd With 1,2-ethanediamine (2:1)

    191. 1h-purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, Compd. With 1,2-ethanediamine (2:1), Mixt. With 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 420.43 g/mol
    Molecular Formula C16H24N10O4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count1
    Exact Mass420.19819929 g/mol
    Monoisotopic Mass420.19819929 g/mol
    Topological Polar Surface Area191 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity273
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAminophylline
    PubMed HealthAminophylline
    Drug ClassesBronchodilator, Theophylline
    Drug LabelAminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methyxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has...
    Active IngredientAminophylline
    Dosage FormInjectable
    RouteInjection
    Strength25mg/ml
    Market StatusPrescription
    CompanyHospira; Luitpold

    2 of 2  
    Drug NameAminophylline
    PubMed HealthAminophylline
    Drug ClassesBronchodilator, Theophylline
    Drug LabelAminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methyxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has...
    Active IngredientAminophylline
    Dosage FormInjectable
    RouteInjection
    Strength25mg/ml
    Market StatusPrescription
    CompanyHospira; Luitpold

    4.2 Therapeutic Uses

    Bronchodilator Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists

    National Library of Medicine's Medical Subject Headings. Aminophylline. Online file (MeSH, 2016). Available from, as of June 24, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Aminophylline is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of July 6, 2016: https://clinicaltrials.gov/search/intervention=Aminophylline

    IV theophylline (often as aminophylline) has been used to relieve the periodic apnea and increase arterial blood pH in patients with Cheyne-Stokes respiration. /NOT included in US product labeling/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3602

    MEDICATION (VET): Aminophylline is indicated for control of reversible airway constriction, to prevent bronchoconstriction, and as an adjunct with other respiratory disease treatment. The uses are are similar to the indications for theophylline because it is a salt form of theophylline. It is used for inflammatory airway disease in cats (feline asthma), dogs, and horses. In dogs, the uses include collapsing trachea, bronchitis, and other airway disease. It has not been effective for respiratory diseases in cattle.

    Papich, M.G. Saunders Handbook of Veterinary Drugs Small and Large Animal. 3rd ed. St. Louis, MO: Elsevier Saunders, 2011, p. 28

    For more Therapeutic Uses (Complete) data for AMINOPHYLLINE (10 total), please visit the HSDB record page.

    4.3 Drug Warning

    Fatalities in adults have generally occurred during or following IV administration of large doses of aminophylline in patients with renal, hepatic, or cardiovascular complications. In other patients, the rapidity of the injection, rather than the dose used, appears to be the more important factor precipitating acute hypotension, seizures, coma, cardiac standstill, ventricular fibrillation, and death. IV aminophylline or theophylline should therefore be given slowly. In children, fatalities usually are a result of overdosage and marked sensitivity to the CNS stimulation of theophylline.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3606

    When administered rectally as suppositories (dosage form no longer commercially available in the US), theophyllines have caused rectal irritation and inflammation. /Theophyllines/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605

    Rapid IV injection of aminophylline may produce dizziness, faintness, lightheadedness, palpitation, syncope, precordial pain, flushing, profound bradycardia, ventricular premature complexes (VPCs, PVCs), severe hypotension, or cardiac arrest. IM injection of aminophylline produces intense local pain and sloughing of tissue ... .

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605

    Theophyllines may also produce transiently increased urinary frequency, dehydration, twitching of fingers and hands, tachypnea, and elevated serum AST (SGOT) concentrations. Hypersensitivity reactions characterized by urticaria, generalized pruritus, and angioedema have been reported with aminophylline administration. A contact-type dermatitis, caused by hypersensitivity to the ethylenediamine component of aminophylline, has also been reported. Bone marrow suppression, leukopenia, thrombocytopenia, and hemorrhagic diathesis have also been reported, but their association with theophylline therapy is questionable. Other adverse effects of theophyllines include albuminuria, increased urinary excretion of renal tubular cells and erythrocytes, hyperglycemia, and syndrome of inappropriate secretion of antidiuretic hormone (SIADH). /Theophyllines/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605

    For more Drug Warnings (Complete) data for AMINOPHYLLINE (22 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of bronchospasm due to asthma, emphysema and chronic bronchitis.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Aminophylline is the ethylenediamine salt of theophylline. Theophylline stimulates the CNS, skeletal muscles, and cardiac muscle. It relaxes certain smooth muscles in the bronchi, produces diuresis, and causes an increase in gastric secretion.

    5.2 MeSH Pharmacological Classification

    Cardiotonic Agents

    Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE). (See all compounds classified as Cardiotonic 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.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Xanthines [CS]; Methylxanthine [EPC]
    5.4 ATC Code

    R - Respiratory system

    R03 - Drugs for obstructive airway diseases

    R03D - Other systemic drugs for obstructive airway diseases

    R03DA - Xanthines

    R03DA05 - Aminophylline

    5.5 Absorption, Distribution and Excretion

    Volume of Distribution

    0.3 to 0.7 L/kg

    Clearance

    0.29 mL/kg/min [postnatal age 3-15 days]

    0.64 mL/kg/min [postnatal age 25-57 days]

    1.7 mL/kg/min [1-4 years]

    1.6 mL/kg/min [4-12 years]

    0.9 mL/kg/min [13-15 years]

    1.4 mL/kg/min [16-17 years]

    0.65 mL/kg/min [Adults (16-60 years), non-smoking asthmatics]

    0.41 mL/kg/min [Elderly (>60 years). liver, and renal function]

    0.33 mL/kg/min [Acute pulmonary edema]

    0.54 mL/kg/min [COPD->60 years, stable non-smoker >1 year]

    0.48 mL/kg/min [COPD with cor pulmonale]

    1.25 mL/kg/min [Cystic fibrosis (14-28 years)]

    0.31 mL/kg/min [Liver disease -cholestasis]

    0.35 mL/kg/min [cirrhosis]

    0.65 mL/kg/min [acute hepatitis]

    0.47 mL/kg/min [Sepsis with multi-organ failure]

    0.38 mL/kg/min [hypothyroid]

    0.8 mL/kg/min [hyperthyroid]

    IV theophylline produces the highest and most rapid serum theophylline concentration. Following a single IV dose of theophylline (as aminophylline) of about 5 mg/kg over 30 minutes to healthy adults, mean peak serum theophylline concentrations of about 10 ug/mL are reached.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607

    In neonates, approximately 50% of the theophylline dose is excreted unchanged in the urine. Beyond the first three months of life, approximately 10% of the theophylline dose is excreted unchanged in the urine. /Theophylline/

    NIH; DailyMed. Current Medication Information for Aminophylline (Aminophylline Dihydrate) Tablet (Updated: March 2012). Available from, as of July 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bc5d8ca-58de-4683-a27a-3e216b20e82b

    When administered IM, theophylline is usually absorbed slowly and incompletely. Rectal suppositories (no longer commercially available in the US) are slowly and erratically absorbed, regardless of whether the suppository base is hydrophilic or lipophilic. /Theophylline/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607

    Dissolution appears to be the rate-limiting step in the absorption of oral theophylline. Under the acidic conditions of the stomach, the theophylline salts and compounds release free theophylline. ... Microcrystalline dosage forms and oral solutions of theophyllines are absorbed more rapidly, but not to a greater extent, than are uncoated tablets. Although the rate of absorption is slower, extended-release preparations (capsules and tablets) of theophylline are generally absorbed to the same extent as uncoated tablets; however, the actual rate of absorption of extended-release preparations may differ. Extended-release preparations of theophyllines have been formulated to release the drug at various rates suitable for dosing every 8-12, 12, or 24 hours; however, the actual dosing frequency for a given patient depends on their individual pharmacokinetic parameters. Since the rate and extent of absorption may differ between various extended-release preparations and sometimes between different dosage sizes of the same preparation, patients should generally be stabilized on a given preparation; substitution of one extended-release preparation for another should generally only be made when the preparations have been shown to be equivalent and/or the patient is evaluated pharmacokinetically during the transition period. Absorption of theophyllines may also be delayed, but is generally not reduced, by the presence of food in the GI tract; however, the effect of food on the absorption of extended-release preparations appears to be variable, and the manufacturer's recommendations for administration of specific preparations should be followed. /Theophyllines/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607

    For more Absorption, Distribution and Excretion (Complete) data for AMINOPHYLLINE (12 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Both the N-demethylation and hydroxylation pathways of theophylline biotransformation are capacity-limited. Due to the wide intersubject variability of the rate of theophylline metabolism, non-linearity of elimination may begin in some patients at serum theophylline concentrations <10 mcg/mL. Since this non-linearity results in more than proportional changes in serum theophylline concentrations with changes in dose, it is advisable to make increases or decreases in dose in small increments in order to achieve desired changes in serum theophylline concentrations. Accurate prediction of dose-dependency of theophylline metabolism in patients a priori is not possible, but patients with very high initial clearance rates (i.e., low steady-state serum theophylline concentrations at above average doses) have the greatest likelihood of experiencing large changes in serum theophylline concentration in response to dosage changes. /Theophylline/

    NIH; DailyMed. Current Medication Information for Aminophylline (Aminophylline Dihydrate) Tablet (Updated: March 2012). Available from, as of July 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bc5d8ca-58de-4683-a27a-3e216b20e82b

    Caffeine and 3-methylxanthine are the only theophylline metabolites with pharmacologic activity. 3-methylxanthine has approximately one tenth the pharmacologic activity of theophylline and serum concentrations in adults with normal renal function are <1 ug/mL. In patients with end-stage renal disease, 3-methylxanthine may accumulate to concentrations that approximate the unmetabolized theophylline concentration. Caffeine concentrations are usually undetectable in adults regardless of renal function. In neonates, caffeine may accumulate to concentrations that approximate the unmetabolized theophylline concentration and thus, exert a pharmacologic effect. /Theophylline/

    NIH; DailyMed. Current Medication Information for Aminophylline (Aminophylline Dihydrate) Tablet (Updated: March 2012). Available from, as of July 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bc5d8ca-58de-4683-a27a-3e216b20e82b

    Theophylline is metabolized by the liver to 1,3-dimethyluric acid, 1-methyluric acid, and 3-methylxanthine. ... Individuals metabolize theophylline at different rates; however, individual metabolism of the drug is generally reproducible. Theophylline and its metabolites are excreted mainly by the kidneys. Renal clearance of the drug, however, contributes only 8-12% of the overall plasma clearance of theophylline. Small amounts of theophylline are excreted in feces unchanged. /Theophylline/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607

    Theophylline is metabolized via the microsomal cytochrome p450 system, primarily by the isozyme CYP1A2. The major pathway is demethylation to 3-methylxanthine in addition to being demethylated or oxidized to other metabolites. Less than 10% of theophylline is excreted in the urine unchanged. /Theophylline/

    Goldfrank, L.R., Goldfrank's Toxicologic Emergencies 9th Ed. 2011., McGraw-Hill, New York, N.Y., p. 954

    Following oral dosing, theophylline does not undergo any measurable first-pass elimination. In adults and children beyond one year of age, approximately 90% of the dose is metabolized in the liver. Biotransformation takes place through demethylation to 1-methylxanthine and 3-methylxanthine and hydroxylation to 1,3-dimethyluric acid. 1-methylxanthine is further hydroxylated, by xanthine oxidase, to 1-methyluric acid. About 6% of a theophylline dose is N-methylated to caffeine. Theophylline demethylation to 3-methylxanthine is catalyzed by cytochrome P-450 1A2, while cytochromes P-450 2E1 and P-450 3A3 catalyze the hydroxylation to 1,3-dimethyluric acid. Demethylation to 1-methylxanthine appears to be catalyzed either by cytochrome P-450 1A2 or a closely related cytochrome. In neonates, the N-demethylation pathway is absent while the function of the hydroxylation pathway is markedly deficient. The activity of these pathways slowly increases to maximal levels by one year of age. /Theophylline/

    NIH; DailyMed. Current Medication Information for Aminophylline (Aminophylline Dihydrate) Tablet (Updated: March 2012). Available from, as of July 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bc5d8ca-58de-4683-a27a-3e216b20e82b

    5.7 Biological Half-Life

    7-9 hours

    Theophylline clearance rates and half-life values were measured in 15 infants aged three to 23 months, after infusion of aminophylline by the intravenous route for at least 24 hours. ... The mean half-life was 4.4 +/- 2.2 hours. There was a tenfold variability in half-life, suggesting that individualization of theophylline dose is especially important in infants if undertreatment and toxicity are to be avoided.

    PMID:711929 Simons FE, Simons KJ; J Clin Pharmacol 18 (10): 472-6 (1978)

    5.8 Mechanism of Action

    Aminophylline is the ethylenediamine salt of theophylline. After ingestion, theophylline is released from aminophylline, and theophylline relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels and reduces airway responsiveness to histamine, methacholine, adenosine, and allergen. Theophylline competitively inhibits type III and type IV phosphodiesterase (PDE), the enzyme responsible for breaking down cyclic AMP in smooth muscle cells, possibly resulting in bronchodilation. Theophylline also binds to the adenosine A2B receptor and blocks adenosine mediated bronchoconstriction. In inflammatory states, theophylline activates histone deacetylase to prevent transcription of inflammatory genes that require the acetylation of histones for transcription to begin.

    Theophylline and aminophylline have been widely used as inhibitors of phosphodiesterase when examining the role of cAMP in regulating cell function. In reality, however, these phosphodiesterase inhibitors may have additional sites of action that could complicate the interpretation of the results. These additional sites of action could include antagonism of inhibitory adenosine autoreceptors and release of intracellular calcium. The purpose of the present study was to determine which of the above three is the primary mechanism by which theophylline and aminophylline affect transmitter release at the mammalian neuromuscular junction. Quantal release measurements were made using intracellular recording techniques. A variety of drugs were used to elucidate this pathway. Isoproterenol, an adenylate cyclase activator, was first used to establish the effect of enhanced levels of cAMP. Theophylline application on its own or in the presence of a drug combination that blocked the adenosine receptor and phosphodiesterase pathways caused significant release depression, opposite to what is expected if it was functioning to enhance cAMP levels. However, when applied in the presence of a drug combination that blocked the adenosine receptor, phosphodiesterase and intracellular ryanodine calcium pathways, theophylline was unable to depress release. Therefore, it was concluded that the major mechanism of action of theophylline is depression of transmitter release by causing the release of intracellular calcium. Aminophylline application alone resulted in a significant enhancement of release. However, when coupled with an adenosine receptor blocker, the ability of aminophylline to enhance transmitter release was blocked, suggesting that its dominant mechanism of action is adenosine receptor inhibition. Taken together, these results indicate that the use of theophylline and aminophylline is inappropriate when examining the role of cAMP at the mammalian neuromuscular junction.

    PMID:16700879 Nickels TJ et al; Clin Exp Pharmacol Physiol 33 (5-6): 465-70 (2006)

    Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects). While the mechanisms of action of theophylline are not known with certainty, studies in animals suggest that bronchodilatation is mediated by the inhibition of two isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilator prophylactic actions are probably mediated through one or more different molecular mechanisms, that do not involve inhibition of PDE III or antagonism of adenosine receptors. Some of the adverse effects associated with theophylline appear to be mediated by inhibition of PDE III (e.g., hypotension, tachycardia, headache, and emesis) and adenosine receptor antagonism (e.g., alterations in cerebral blood flow). Theophylline increases the force of contraction of diaphragmatic muscles. This action appears to be due to enhancement of calcium uptake through an adenosine-mediated channel. /Theophylline/

    NIH; DailyMed. Current Medication Information for Aminophylline (Aminophylline Dihydrate) Tablet (Updated: March 2012). Available from, as of July 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bc5d8ca-58de-4683-a27a-3e216b20e82b

    API SUPPLIERS

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    Aarti Pharmalabs

    India

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    Submission : 1980-09-25

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    Roche Diagnostics GmbH

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    GDUFA

    DMF Review : N/A

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    DMF Number : 3966

    Submission : 1980-09-26

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    Bakul Group

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    China

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    NDC Package Code : 58624-0544

    Start Marketing Date : 1983-10-01

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    CSPC New Nova Pharmaceutical

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    Certificate Number : R0-CEP 2007-345 - Rev 01

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    Certificate Number : R1-CEP 2004-140 - Rev 00

    Issue Date : 2011-09-19

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    Substance Number : 300

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    S.S.Pharmachem

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    Siegfried AG

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    Siegfried AG

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    Certificate Number : R1-CEP 2007-288 - Rev 01

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    API Reference Price

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S","supplier":"AURA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MATADI","customer":"TO","customerCountry":"CONGO D REPULIC","quantity":"800.00","actualQuantity":"800","unit":"KGS","unitRateFc":"14.6","totalValueFC":"11605.1","currency":"USD","unitRateINR":1215.6527874999999,"date":"13-Sep-2024","totalValueINR":"972522.23","totalValueInUsd":"11605.1","indian_port":"JNPT","hs_no":"29335910","bill_no":"3976648","productDescription":"API","marketType":"REGULATED MARKET","country":"CONGO D REPULIC","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"306 A-WING HARI OM PLAZA M G ROAD, MUMBAI M S","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"AMINOPHYLLINE ANHYDROUS BP PH, EUR(INV NO:PEX\/0658\/24-25 DATE: 19\/09\/2024) CAS NO:317-34-0.","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"KARACHI","customer":"THE BANK OF ","customerCountry":"PAKISTAN","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"12","totalValueFC":"2374.2","currency":"USD","unitRateINR":994.79999999999995,"date":"26-Sep-2024","totalValueINR":"198960","totalValueInUsd":"2374.2","indian_port":"JNPT","hs_no":"29335910","bill_no":"4361885","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"AMINOPHYLLINE BP (ANHYDROUS) AS PER INV","address":"FF\/12, SANIDHYA BUILDING, OPP-","city":"AHMEDABAD","supplier":"DHARMANANDAN EXPORT PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JEBEL ALI","customer":"ASTRON SHIPPING LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"19.5","totalValueFC":"482.2","currency":"USD","unitRateINR":1620.5896,"date":"22-Oct-2024","totalValueINR":"40514.74","totalValueInUsd":"482.2","indian_port":"Ahmedabad ICD","hs_no":"29335910","bill_no":"5031713","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad ICD","supplierAddress":"FF\/12, SANIDHYA BUILDING, OPP-, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"AMINOPHYLLINE BP (ANHYDROUS) AS PER INV","address":"FF\/12, SANIDHYA BUILDING, OPP-","city":"AHMEDABAD","supplier":"DHARMANANDAN EXPORT PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JEBEL ALI","customer":"ASTRON SHIPPING LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"19.5","totalValueFC":"482.2","currency":"USD","unitRateINR":1620.5896,"date":"22-Oct-2024","totalValueINR":"40514.74","totalValueInUsd":"482.2","indian_port":"Ahmedabad ICD","hs_no":"29335910","bill_no":"5033995","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad ICD","supplierAddress":"FF\/12, SANIDHYA BUILDING, OPP-, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"AMINOPHYLLINE ANHYDROUS BP(INV NO:PEX\/0786\/24-25 DATE: 18\/10\/2024) CAS NO:317-34-0.","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"KARACHI","customer":"TO THE ORDER OF","customerCountry":"PAKISTAN","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"9","totalValueFC":"17822.9","currency":"USD","unitRateINR":748.79999999999995,"date":"23-Oct-2024","totalValueINR":"1497600","totalValueInUsd":"17822.9","indian_port":"JNPT","hs_no":"29335910","bill_no":"5072128","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"AMINOPHYLLINE ANHYDROUS BP\/PH.EUR (INV NO:PEX\/0840\/24-25 DATE: 04\/11\/2024) CAS NO:317-34-0.","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"KARACHI","customer":"UNITED BANK LTD","customerCountry":"PAKISTAN","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"13","totalValueFC":"2571.1","currency":"USD","unitRateINR":1084.8499999999999,"date":"12-Nov-2024","totalValueINR":"216970","totalValueInUsd":"2571.1","indian_port":"JNPT","hs_no":"29335910","bill_no":"5542798","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"RAW MATERIAL USE IN PHARMACEUTICAL INDUSTRIES AMINOPHYLLINE B.P.(AS PER INVOICE)","address":"814, `DEVPATH`, BESIDE LAL BUNGLOW,","city":"C.G.ROAD\/ AHMEDABD\/GUJARAT","supplier":"ESPEE PHARMA CHEM ","supplierCountry":"INDIA","foreign_port":"MATADI","customer":"TO THE ORDER","customerCountry":"CONGO D REPULIC","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"18.5","totalValueFC":"1829.4","currency":"USD","unitRateINR":1543.8235999999999,"date":"13-Nov-2024","totalValueINR":"154382.36","totalValueInUsd":"1829.4","indian_port":"Thar Dry Port ICD\/Ahmedabad Gujarat ICD","hs_no":"29335910","bill_no":"5580382","productDescription":"API","marketType":"REGULATED MARKET","country":"CONGO D REPULIC","selfForZScoreResived":"Pharma Grade","supplierPort":"Thar Dry Port ICD\/Ahmedabad Gujarat ICD","supplierAddress":"814, `DEVPATH`, BESIDE LAL BUNGLOW,, C.G.ROAD\/ AHMEDABD\/GUJARAT","customerAddress":""}]
    08-Apr-2021
    13-Nov-2024
    KGS
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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    (KGS)    		 Average Price
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    Fillers, Diluents & Binders

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    01

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : ProBlend®

    Application : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants

    Excipient Details : ProBlend (Microcrystalline Cellulose) is used as a filler, binder, glidant, DC & co-processed excipient in tablets, capsules, and MUPS formulations.

    Pharmacopoeia Ref : USP-NF

    Technical Specs : NA

    Ingredient(s) : Microcrystalline Cellulose

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    Gangwal Healthcare

    India
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : DiCOM-DC® PL009 P60

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : DiCOM-DC PL009 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : IH

    Technical Specs : NA

    Ingredient(s) : Maize Starch

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    Gangwal Healthcare DiCOM-DC® PL009 P60

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    03

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • EDQM
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : DiCOM-DC® SP204

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

    Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : NA

    Ingredient(s) : Corn Starch, Pregelatinized

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    04

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
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    • EDQM
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : Microlose™ M60 P60

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

    Ingredient(s) : Lactose Monohydrate

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    05

    Sigachi Industries

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    06

    Microlex e.U

    Austria
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    07

    Sigachi Industries

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    08

    Microlex e.U

    Austria
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    09

    Shanghai Shenmei Pharmaceutical Te...

    China
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    10

    Prachin Chemical

    India
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    Direct Compression

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    01

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : ProBlend®

    Application : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants

    Excipient Details : ProBlend (Microcrystalline Cellulose) is used as a filler, binder, glidant, DC & co-processed excipient in tablets, capsules, and MUPS formulations.

    Pharmacopoeia Ref : USP-NF

    Technical Specs : NA

    Ingredient(s) : Microcrystalline Cellulose

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    Gangwal Healthcare ProBlend®

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    02

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : DiCOM-DC® PL009 P60

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : DiCOM-DC PL009 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : IH

    Technical Specs : NA

    Ingredient(s) : Maize Starch

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    Gangwal Healthcare DiCOM-DC® PL009 P60

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    03

    Gangwal Healthcare

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : DiCOM-DC® SP204

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

    Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : NA

    Ingredient(s) : Corn Starch, Pregelatinized

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    Gangwal Healthcare DiCOM-DC® SP204

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    04

    Gangwal Healthcare

    India
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    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : DiCOM-DC® SR300

    Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

    Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : NA

    Ingredient(s) : EthylCellulose

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    Gangwal Healthcare DiCOM-DC® SR300

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    Gangwal Healthcare

    India
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    • EDQM
    • WHO-GMP

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    Brand Name : Microlose™ M60 P60

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

    Ingredient(s) : Lactose Monohydrate

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    DFE Pharma

    Germany
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    Sigachi Industries

    India
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    08

    Sigachi Industries

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    09

    Sigachi Industries

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    Sigachi Industries

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    Lubricants & Glidants

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    Granulation

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    ABOUT THIS PAGE

    Aminophylline Manufacturers

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

    Aminophylline Suppliers

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

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

    Aminophylline USDMF

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

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

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

    Aminophylline JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Aminophylline Drug Master File in Japan (Aminophylline JDMF) empowers Aminophylline API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Aminophylline JDMF during the approval evaluation for pharmaceutical products. At the time of Aminophylline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Aminophylline suppliers with JDMF on PharmaCompass.

    Aminophylline CEP

    A Aminophylline CEP of the European Pharmacopoeia monograph is often referred to as a Aminophylline Certificate of Suitability (COS). The purpose of a Aminophylline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aminophylline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aminophylline to their clients by showing that a Aminophylline CEP has been issued for it. The manufacturer submits a Aminophylline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aminophylline CEP holder for the record. Additionally, the data presented in the Aminophylline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aminophylline DMF.

    A Aminophylline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aminophylline 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 Aminophylline suppliers with CEP (COS) on PharmaCompass.

    Aminophylline 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 Aminophylline as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Aminophylline 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 Aminophylline 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 Aminophylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aminophylline NDC to their finished compounded human drug products, they may choose to do so.

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

    Aminophylline GMP

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

    Aminophylline CoA

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

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

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