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    Chemistry

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    Also known as: (+)-pseudoephedrine, D-pseudoephedrine, Isoephedrine, Trans-ephedrine, D-isoephedrine, Psi-ephedrin
    Molecular Formula
    C10H15NO
    Molecular Weight
    165.23  g/mol
    InChI Key
    KWGRBVOPPLSCSI-WCBMZHEXSA-N
    FDA UNII
    7CUC9DDI9F
    Pseudoephedrine
    A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.
    Pseudoephedrine is an alpha-Adrenergic Agonist. The mechanism of action of pseudoephedrine is as an Adrenergic alpha-Agonist.
    1 2D Structure

    Pseudoephedrine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol
    2.1.2 InChI
    InChI=1S/C10H15NO/c1-8(11-2)10(12)9-6-4-3-5-7-9/h3-8,10-12H,1-2H3/t8-,10+/m0/s1
    2.1.3 InChI Key
    KWGRBVOPPLSCSI-WCBMZHEXSA-N
    2.1.4 Canonical SMILES
    CC(C(C1=CC=CC=C1)O)NC
    2.1.5 Isomeric SMILES
    C[C@@H]([C@H](C1=CC=CC=C1)O)NC
    2.2 Other Identifiers
    2.2.1 UNII
    7CUC9DDI9F
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Ephedrine Threo Isomer

    2. Isoephedrine

    3. Pseudoephedrine Hcl

    4. Pseudoephedrine Hydrochloride

    5. Sudafed

    6. Threo Isomer Of Ephedrine

    2.3.2 Depositor-Supplied Synonyms

    1. (+)-pseudoephedrine

    2. D-pseudoephedrine

    3. Isoephedrine

    4. Trans-ephedrine

    5. D-isoephedrine

    6. Psi-ephedrin

    7. Sudafed

    8. Psi-ephedrine

    9. (+)-threo-ephedrine

    10. D-psi-ephedrine

    11. 90-82-4

    12. L(+)-psi-ephedrine

    13. L-(+)-pseudoephedrine

    14. (+)-psi-ephedrine

    15. Pseudoefedrina

    16. Pseudoephedrinum

    17. Besan

    18. (+)-(1s,2s)-pseudoephedrine

    19. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol

    20. Pseudoephedrine D-form

    21. (1s,2s)-pseudoephedrine

    22. (1s,2s)-(+)-pseudoephedrine

    23. Neodurasina

    24. Acunaso

    25. D-psi-2-methylamino-1-phenyl-1-propanol

    26. Pseudoephedrine, (+)-

    27. Isoephedrine, D-

    28. Pseudoephedrine (inn)

    29. 7cuc9ddi9f

    30. Chebi:51209

    31. Pseudoephedrine, L-(+)-

    32. Alpha-(1-(methylamino)ethyl)benzyl Alcohol

    33. Pseudoephedrine (d)

    34. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, (alpha-s)-

    35. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, (.alpha.s)-

    36. Pseudoefedrina [inn-spanish]

    37. Pseudoephedrinum [inn-latin]

    38. (+) Threo-2-(methylamino)-1-phenyl-1-propanol

    39. Pseudoephedrine [inn]

    40. Pseudoephedrine [inn:ban]

    41. Pseudoephedrine Ephedrine

    42. Psi-ephedrine, (+)-

    43. 2-(methylamino)-1-phenyl-1-propanol

    44. Neodurasina (tn)

    45. Acunaso (tn)

    46. Pseudophedrine Sulphate

    47. Hsdb 3177

    48. Pseudoephedrine Polistirex

    49. Einecs 202-018-6

    50. Unii-7cuc9ddi9f

    51. Benzenemethanol, .alpha.-((1s)-1-(methylamino)ethyl)-, (.alpha.s)-

    52. (i)-ephedrin

    53. Ephedrine-(racemic)

    54. (+) Pseudoephedrine

    55. D-pseudoephedrine Base

    56. Spectrum_000878

    57. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, (s-(r*,r*))-

    58. Spectrum2_001303

    59. Spectrum3_001771

    60. Spectrum4_001162

    61. Spectrum5_000650

    62. Lopac-e-3250

    63. (1s,2s) Pseudoephedrine

    64. (1s,2s)-2-methylamino-1-phenylpropan-1-ol

    65. (1s, 2s) Pseudoephedrine

    66. Ec 202-018-6

    67. Schembl4368

    68. Chembl1590

    69. Pseudoephedrine [mi]

    70. (1s,2s)-2-(methylamino)-1-phenyl-propan-1-ol

    71. Bspbio_003261

    72. Kbiogr_001763

    73. Kbioss_001358

    74. Bidd:gt0817

    75. Divk1c_000451

    76. Pseudoephedrine [hsdb]

    77. Spbio_001365

    78. Pseudoephedrine [vandf]

    79. Gtpl7286

    80. Pseudoephedrine [mart.]

    81. Benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, (s-(r*,r*))-

    82. Dtxsid0023537

    83. Pseudoephedrine [who-dd]

    84. Kbio1_000451

    85. Kbio2_001358

    86. Kbio2_003926

    87. Kbio2_006494

    88. Kbio3_002762

    89. Zinc20259

    90. (1s, 2s)-(+)-pseudoephedrine

    91. Ninds_000451

    92. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, (alphas)-

    93. Pdsp1_001347

    94. Akos025401512

    95. Db00852

    96. Idi1_000451

    97. (1s,2s)-(+)-pseudoephedrine, 98%

    98. Ncgc00015408-01

    99. Ncgc00178180-01

    100. Nci60_002955

    101. Sbi-0051498.p003

    102. 1-(s),2-(r)-erythro-(+)-ephedrine

    103. C02765

    104. D08449

    105. 064p256

    106. Q263958

    107. Brd-k84175871-003-02-2

    108. Ephedrine Hydrochloride Impurity B [ep Impurity]

    109. (.alpha.s)-.alpha.-((1r)-1-(methylamino)ethyl)benzenemethanol

    110. (s,s)-(+)-pseudoephedrine Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 165.23 g/mol
    Molecular Formula C10H15NO
    XLogP30.9
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count3
    Exact Mass165.115364102 g/mol
    Monoisotopic Mass165.115364102 g/mol
    Topological Polar Surface Area32.3 Ų
    Heavy Atom Count12
    Formal Charge0
    Complexity121
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAfrinol
    Active IngredientPseudoephedrine sulfate
    Dosage FormTablet, extended release
    RouteOral
    Strength120mg
    Market StatusOver the Counter
    CompanySchering Plough

    2 of 2  
    Drug NameAfrinol
    Active IngredientPseudoephedrine sulfate
    Dosage FormTablet, extended release
    RouteOral
    Strength120mg
    Market StatusOver the Counter
    CompanySchering Plough

    4.2 Therapeutic Uses

    The Combat Methamphetamine Epidemic Act of 2005 has been incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine. The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine. In addition, stores are required to keep personal information about purchasers for at least two years.

    FDA, Center for Drug Evaluation and Research (CDER); Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine (May 8, 2006). Available from, as of March 12, 2007: https://www.fda.gov/cder/news/methamphetamine.htm

    Pseudoephedrine is indicated for temporary relief of congestion associated with acute coryza, acute eustachian salpingitis, serous otitis media with eustachian tube congestion, vasomotor rhinitis, and aerotitis (barotitis) media. Pseudoephedrine also be indicated as an adjunct to analgesics, antihistamines, antibiotics, antitussive, or expectorants for optimum results in allergic rhinitis, croup, acute and subacute sinusitis, acute otitis medica and acute tracheobronchitis. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2452

    Although pseudoephedrine has been used in the symptomatic treatment of bronchial asthma and reversible bronchospasm, the drug appear to be ineffective as a bronchodilator.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1354

    /This study assessed whether/ pseudoephedrine hydrochloride is effective in decreasing the risk for earache ... in chlidren traveling by air. ... Children aged 6 months to 6 years were included in this study. Pseudoephedrine hydrochloride (1 mg/kg body weight) or placebo was administered 30 to 60 minutes prior to departure on commercial air flights. Caregivers noted historical details and the degree of apparent ear pain, drowsiness, and excitability with ascent and descent. Ninety-one flights involving 50 children were studied, with ear pain being reported in 13 (14%) of flights. Ear pain was not associated with a history of air travel-associated ear pain, recent ear infection, or recent upper airway symptoms. Pseudoephedrine use was not associated with a decrease in ear pain during either ascent (4% with pseudoephedrine vs 5% with placebo; P approximately 1.00) or descent (12% with pseudoephedrine vs. 13% with placebo; P approximately 1.00). Pseudoephedrine use was, however, linked to drowsiness at takeoff (60% with pseudoephedrine vs. 27% with placebo; P = .003) but not at landing (P = .39). Treatment was not associated with excitability at takeoff (P = .09) or landing (P approximately 1.00). Ear pain is not uncommon in children traveling by commercial aircraft. The predeparture use of pseudoephedrine does not decrease the risk for in-flight ear pain in children but is associated with drowsiness. /Pseudoephedrine Hydrochloride/

    PMID:10323625 Buchanan BJ et al; Arch Pediatr Adolesc Med 153 (5): 466-8 (1999)

    For more Therapeutic Uses (Complete) data for PSEUDOEPHEDRINE (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    Maternal Medication usually Compatible with Breast-Feeding: Pseudoephedrine: Reported Sign or Symptom in Infant or Effect on Lactation: None. /from Table 6/

    Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 141 (1994)

    Pseudoephedrine may cause mild CNS stimulation, especially in patients who are hypersensitive to the effects of sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may occur. Headache and drowsiness also have been reported.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1355

    As with other sympathomimetic drugs, pseudoephedrine should not be used for self-medication in patients with hyperthyroidism, diabetes mellitus, hypertension, ischemic heart disease, or difficulty urinating secondary to prostatic hypertrophy without consulting a clinician. The drug should be used cautiously, and may be contraindicated, in patients who are hypersensitive to the effects of other sympathomimetic drugs. Pseudoephedrine is contraindicated in patients with severe hypertension, severe coronary artery disease, angle-closure glaucoma, or urinary retention.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1355

    Geriatric patients may be especially sensitive to the effects of sympathomimetic amines. Overdosage of sympathomimetic amines in patients older than 60 years of age may cause hallucinations, CNS depression, seizures, and death. Extended-release preparations containing pseudoephedrine therefore should not be administered to these patients until safety has been established by administration of a short-acting preparation.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1355

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

    4.4 Drug Indication

    Pseudoephedrine is a sympathomimetic amine used for its decongestant activity.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Pseudoephedrine causes vasoconstriction which leads to a decongestant effect. It has a short duration of action unless formulated as an extended release product. Patients should be counselled regarding the risk of central nervous system stimulation.

    5.2 MeSH Pharmacological Classification

    Nasal Decongestants

    Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)

    Bronchodilator Agents

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

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    PSEUDOEPHEDRINE
    5.3.2 FDA UNII
    7CUC9DDI9F
    5.3.3 Pharmacological Classes
    Established Pharmacologic Class [EPC] - alpha-Adrenergic Agonist
    5.4 ATC Code

    R01BA02

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    R - Respiratory system

    R01 - Nasal preparations

    R01B - Nasal decongestants for systemic use

    R01BA - Sympathomimetics

    R01BA02 - Pseudoephedrine

    5.5 Absorption, Distribution and Excretion

    Absorption

    A 240mg oral dose of pseudoephedrine reaches a Cmax of 246.310.5ng/mL fed and 272.513.4ng/mL fasted, with a Tmax of 6.601.38h fed and 11.870.72h fasted, with an AUC of 6862.0334.1ng\*h/mL fed and 7535.1333.0ng\*h/mL fasted.

    Route of Elimination

    55-75% of an oral dose is detected in the urine as unchanged pseudoephedrine.

    Volume of Distribution

    The apparent volume of distribution of pseudoephedrin is 2.6-3.3L/kg.

    Clearance

    A 60mg oral dose of pseudoephedrine has a clearance of 5.91.7mL/min/kg.

    Elimination: Renal. About 55 to 75% of a dose is excreted unchange. The rate of excretion is accelerated in acidic urine.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2452

    Oral capsules containing 100 mg pseudoephedrine hydrochloride and different grades of sodium alginate were prepared and studied to determine drug dissolution, the penetration of dissolution medium into the capsules, and the bioavailability of the formulations in 16 healthy subjects (ages 19-24 yr) using a randomized crossover design. At pH 1.2, there was no difference in dissolution between the formulations. At pH 7.2, release rates correlated with the viscosity grade of sodium alginate. Bioavailability tests confirmed that capsules containing high viscosity grades of alginate led to slow release, with a time to reach peak concn of 6.5 hr, and no loss of amount of drug absorbed. It was concluded that controlled release pseudoephedrine capsules can be prepared with high viscosity grades of sodium alginate. /Pseudoephedrine hydrochloride/

    Veski P et al; Int J Pharm 111: 171-79 (1994)

    The release of pseudoephedrine hydrochloride from beadlets coated with different levels of Eudragit S-100 and Eudragit RS was studied. In vitro dissolution studies indicated that the coating levels types of resins and types of plasticizers in the film played a major role in determining drug release rate profiles. Drug release appeared to follow first order kinetics. A coating of 2% Eudragit S-100 eliminated the formation of soft lumps which are commonly seen with Eudragit RS coated beadlets. Eudragit S-100 coating also contributed to retarding drug release in dissolution media at pH 1.2-6.5. It was concluded that pseudoephedrine release from coated beadlets depended on coating levels types of resins and types of plasticizers used. /Pseudoephedrine hydrochloride/

    Li SP et al; Drug Dev Ind Pharm 17 (12): 1655-83 (1991)

    Only three drugs are commonly used as oral decongestants: phenylpropanolamine (PPA), pseudoephedrine (PDE), and phenylephrine (PE). They are all chiral drugs that exist as stereoisomers. It is possible that each enantiomer can reflect significant enantioselective differences with regard to both pharmacokinetic and pharmacodynamic effects. Both PPA and PDE are readily and completely absorbed, whereas PE, with a bioavailability of only approximately 38%, is subject to gut wall metabolism and is thought to be absorbed erratically. Peak concn are reached between 0.5 and 2 hr after admin. All three drugs are extensively distributed into extravascular sites (apparent volume of distribution between 2.6 and 5.0 L/kg). No protein binding data in humans are available. Whereas PPA and PDE are not substantially metabolized, PE undergoes extensive biotransformation in the gut wall and the liver. Elimination of PPA and PDE is predominantly renal, with urinary excretion being pH dependent. Half-lives are relatively short, approximately 2.5 hr for PE, 4 hr for PPA, and 6 hr for PDE. Elimination of PPA and PDE may be rapid in children, and the agents should be used with caution in patients with renal impairment. In addition, PPA incr caffeine plasma levels and decr theophylline clearance. Reduced metabolism of PE occurs with concurrent admin of monoamine oxidase inhibitors. No direct relationship between nasal decongestant effect and plasma concentration has been established.

    Kanfer I et al; 13 (6 Pt 2): 116S-28S (1993)

    For more Absorption, Distribution and Excretion (Complete) data for PSEUDOEPHEDRINE (13 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Pseudoephedrine is <1% N-demethylated to an inactive metabolite. The majority of pseudoephedrine is eliminated unmetabolized in the urine.

    Pseudoephedrine is incompletely metabolized (less than 1%) in the liver by N-demethylation to an inactive metabolite. The drug and its metabolite are excreted in urine; 55-96% of a dose is excreted unchanged.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1356

    D-PSEUDOEPHEDRINE YIELDS D-NORPSEUDOEPHEDRINE & L-PSEUDOEPHEDRINE YIELDS L-NORPSEUDOEPHEDRINE IN RABBIT: DANN, RE ET AL, EUR J PHARMAC, 16, 233 (1971). /FROM TABLE/

    Goodwin, B.L. Handbook of Intermediary Metabolism of Aromatic Compounds. New York: Wiley, 1976., p. 43

    Ephedrine (EPH), pseudoephedrine (PEPH), phenylpropanolamine (PPA), methylephedrine (MEPH) and cathine are sympathomimetic amines. ... Excretion studies of the ephedrine-related drugs have been performed to better understand the metabolic yields of ephedrines in urine. After consuming a single clinical dose of each of these drugs, urine samples from volunteers (n=3 for each drug) were subjected to tert-butyl-methyl-ether (TBME) extraction and trifluoroacetic acid (TFAA) derivatization before gas chromatography-mass spectrometry (GC-MS) analysis. Most ephedrines were excreted unchanged in urine, including EPH (40.9%), PEPH (72.2%), and PPA (59.3%). However, only a relatively small amount of MEPH (15.5%) was excreted unchanged in urine. In addition, a trace amount of PPA (1.6%) and cathine (0.7%) was found to be the metabolites of EPH and PEPH, respectively. Urinary EPH, PEPH, and PPA reached peaks at 2-6 hr and disappeared in urine at approximately 24-48 hr post-administration. ...

    PMID:15885945 Tseng YL et al; Forensic Sci Int 157 (2-3): 149-55 (2006)

    5.7 Biological Half-Life

    The mean elimination half life of pseudoephedrine is 6.0h.

    In two sequential double-blind, parallel-group, single-dose studies, 21 children received either pseudoephedrine, 30 or 60 mg, or placebo, and 20 children received either phenylpropanolamine, 20 or 37.5 mg, or placebo. Before dosing and at intervals up to 7 hours after dosing, serum pseudoephedrine or phenylpropanolamine concentrations were measured, and pulse and blood pressure were recorded. In two children receiving each drug, these tests were also performed at 12 and 24 hours, and urine was collected from 0 to 12 and from 12 to 24 hours. In children, the mean (+/-SEM) terminal elimination half-life values for pseudoephedrine, 3.1 +/- 0.5 hours, and for phenylpropanolamine, 2.6 +/- 0.6 hours, were significantly shorter than those found by other investigators in adults. Pharmacokinetics were not dose dependent in the dose ranges studied.

    PMID:8917241 Simons FE et al; J Pediatr 129 (5): 729-34 (1996)

    Urinary pH can affect the elimination half-life of pseudoephedrine, prolonging it when alkaline (pH 8) and reducing it when acidic (pH 5). The elimination half-life of pseudoephedrine ranges from 3-6 or 9-16 hours when urinary pH is 5 or 8, respectively, while when urinary pH is 5.8, the elimination half-life of the drug ranges from 5-8 hours. In one study in children 6-12 years of age, the elimination half-life of pseudoephedrine averaged about 3 hours when urinary pH was 6.5.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 1356

    5.8 Mechanism of Action

    Pseudoephedrine acts mainly as an agonist of alpha adrenergic receptors and less strongly as an agonist of beta adrenergic receptors. This agonism of adrenergic receptors produces vasoconstriction which is used as a decongestant and as a treatment of priapism. Pseudoephedrine is also an inhibitor of norepinephrine, dopamine, and serotonin transporters. The sympathomimetic effects of pseudoephedrine include an increase in mean arterial pressure, heart rate, and chronotropic response of the right atria. Pseudoephedrine is also a partial agonist of the anococcygeal muscle. Pseudoephedrine also inhibits NF-kappa-B, NFAT, and AP-1.

    THESE AGENTS /BRONCHODILATORS/ ACT ON BETA-2 RECEPTORS TO RELAX BRONCHIAL SMOOTH MUSCLE & PERIPHERAL VASCULATURE, APPARENTLY BY STIMULATING PRODN OF CYCLIC ADENOSINE-3.5-MONOPHOSPHATE (CAMP)...

    American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 627

    Pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes; reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. Also, drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2452

    The pharmacological properties of the ephedrine derivative pseudoephedrine were investigated at the nuclear level. Following intraperitoneal injection of Sprague Dawley rats with pseudoephedrine, Fos induction was measured in various brain areas by Western blots and immunocytochemistry. Pseudoephedrine induced Fos-like immunoreactivity in the nucleus accumbens and striatum in a time and concentration-dependent manner with maximal effect at 60 mg/kg 2 hr after injection. Immunocytochemical studies confirmed that the majority of the signal was detectable in the nucleus accumbens and striatum. Pre-injection with the D1 dopamine receptor antagonist SCH23390 partially and completely blocked pseudoephedrine-induced Fos-like immunoreactivity in the striatum and nucleus accumbens, respectively, suggesting that the action of pseudoephedrine is mediated via dopamine release and results in the activation of D1 dopamine receptors. With the exception of the higher doses required, the actions of pseudoephedrine were similar to those previously described for the psychostimulant amphetamine.

    PMID:10471092 Kumarnsit E et al; Neuropharmacology 38 (9): 1381-7 (1999)

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    Pharm-RX Chemical

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    SupplySide West
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Pharm RX

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    02

    Malladi Drugs & Pharmaceuticals Li...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Sampe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57218-500

    Start Marketing Date : 2003-01-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Malladi

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    03

    Siegfried AG

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    American Chemical Society
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSiegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-05

    Pay. Date : 2013-01-24

    DMF Number : 4185

    Submission : 1981-05-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    04

    Cyalume Specialty Products

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Sampe
    Not Confirmed
    arrow

    Cyalume Specialty Products

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Sampe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23482

    Submission : 2010-01-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Cadila Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Sampe
    Not Confirmed
    arrow

    Cadila Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Sampe
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20819

    Submission : 2007-08-06

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Sampe
    Not Confirmed
    arrow

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Sampe
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3620

    Submission : 1979-09-06

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    07

    Embio Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Sampe
    Not Confirmed
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    NDC API

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    01

    Malladi Drugs & Pharmaceuticals Lim...

    India
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    BPI Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    PSEUDOEPHEDRINE

    NDC Package Code : 57218-500

    Start Marketing Date : 2003-01-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Malladi

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    Listed Suppliers

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    01

    Pharm-RX Chemical

    U.S.A
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    SupplySide West
    Attending
    • fda
    • EDQM
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    Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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    Pseudoephedrine

    About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...

    Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a highly selective supplier qualification process, including direct visits to overseas manufacturers, to maintain high quality standards. Pharm-Rx’s growth is driven by a consistent focus on quality ingredients, competitive pricing, and customer service. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Pharm RX

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    02

    Malladi Drugs & Pharmaceuticals Lim...

    India
    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    Pseudoephedrine

    About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...

    Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in the cough and cold segment, with strong presence in antihistamines, anti-convulsants, anti-depressants, and anxiolytics. Malladi exports to around 60 countries, with over 85% revenue from exports, and its facilities are approved by FDA, EDQM, KFDA, TGA, and other agencies. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Malladi

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    03

    Siegfried AG

    Switzerland
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    American Chemical Society
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSiegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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    Pseudoephedrine

    About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...

    Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production sites across three continents, we support customers across the full value chain, from process development and optimization to manufacturing, packaging, and logistics. Founded in 1873 in Zofingen, Switzerland, Siegfried combines deep pharmaceutical and chemical expertise with global scale to deliver high-quality medicines reliably to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    04

    Embio Limited

    India
    PCC
    Not Confirmed
    arrow

    Embio Limited

    India
    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    d-Pseudoephedrine base

    About the Company : At Embio, technology is the foundation of our success, driving leadership in every product we manufacture. With 30+ years of expertise in bacterial, fungal, and Category 1 GMO biot...

    At Embio, technology is the foundation of our success, driving leadership in every product we manufacture. With 30+ years of expertise in bacterial, fungal, and Category 1 GMO biotransformation, we develop fully backward-integrated platforms, creating a first-mover advantage in global markets. A leading manufacturer of Schedule-1 and Schedule-2 substances, Embio excels in controlled substances, intermediates, and chiral molecules. Our US-FDA, PMDA, KFDA, COFEPRIS, and WHO-GMP-approved facility in MIDC Mahad serves 70+ countries, including top 10 pharma companies.
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    Drugs in Development

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    LTL Pharma to Take Over Sanofi’s Diregura in Japan

    Details:

    LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).


    Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area: Immunology Brand Name: Diregura

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Ltl Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration August 04, 2020

    Sanofi Company Banner

    01

    Sanofi

    France
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    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Ltl Pharma

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    LTL Pharma to Take Over Sanofi’s Diregura in Japan

    Details : LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).

    Product Name : Diregura

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    August 04, 2020

    Sanofi Company Banner

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

    Details:

    Fexofenadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Seasonal.


    Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 02, 2011

    Sanofi Company Banner

    02

    Sanofi

    France
    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allerg...

    Details : Fexofenadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Seasonal.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 02, 2011

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    Virtual Booth

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy’s Announces the First-to-Market Launch of Over-the-Counter, Store-Brand Equivalent of Allegra-D® 24 Hr in the U.S. Market

    Details:

    Allegra-D (fexofenadine) is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies.


    Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Allegra-D

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 22, 2022

    Dr Reddy Company Banner

    03

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dr. Reddy’s Announces the First-to-Market Launch of Over-the-Counter, Store-Brand Equivalent of ...

    Details : Allegra-D (fexofenadine) is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies.

    Product Name : Allegra-D

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 22, 2022

    Dr Reddy Company Banner

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    • Development Update
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

    Details:

    Desloratadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Desloratadine,Pseudoephedrine

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 10, 2012

    Dr Reddy Company Banner

    04

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Desloratadine,Pseudoephedrine

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Condi...

    Details : Desloratadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 10, 2012

    Dr Reddy Company Banner

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    Virtual Booth

    • Development Update
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions

    Details:

    Desloratadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Desloratadine,Pseudoephedrine

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 14, 2011

    Dr Reddy Company Banner

    05

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Desloratadine,Pseudoephedrine

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under F...

    Details : Desloratadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 14, 2011

    Dr Reddy Company Banner

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    Virtual Booth

    • Development Update
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Barotrauma in Hyperbaric Oxygen Therapy

    Details:

    Pseudoephedrine is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Barotrauma.


    Lead Product(s): Pseudoephedrine,Inapplicable

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 25, 2023

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    06

    John Muir Health

    Country
    arrow
    PCC
    Not Confirmed

    John Muir Health

    Country
    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Pseudoephedrine,Inapplicable

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Barotrauma in Hyperbaric Oxygen Therapy

    Details : Pseudoephedrine is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Barotrauma.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 25, 2023

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    A Study of Continuous Blood Pressure Monitoring in Healthy Participants

    Details:

    Propranolol is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Propranolol Hydrochloride,Pseudoephedrine

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 20, 2023

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    07

    Eli Lilly

    U.S.A
    arrow
    PCC
    Not Confirmed

    Eli Lilly

    U.S.A
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    PCC
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Propranolol Hydrochloride,Pseudoephedrine

    Therapeutic Area : Undisclosed

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study of Continuous Blood Pressure Monitoring in Healthy Participants

    Details : Propranolol is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 20, 2023

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    • Development Update
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    Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil

    Details:

    Levocetirizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic.


    Lead Product(s): Levocetirizine Dihydrochloride,Pseudoephedrine

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2022

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    08

    Eurofarma Laboratorios S.A

    Brazil
    arrow
    PCC
    Not Confirmed

    Eurofarma Laboratorios S.A

    Brazil
    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Levocetirizine Dihydrochloride,Pseudoephedrine

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhini...

    Details : Levocetirizine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 05, 2022

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    • Development Update
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    A Study of Continuous Heart Rate Monitoring in Healthy Participants

    Details:

    Propranolol is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Propranolol Hydrochloride,Pseudoephedrine

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 23, 2020

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    Eli Lilly

    U.S.A
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    Eli Lilly

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Propranolol Hydrochloride,Pseudoephedrine

    Therapeutic Area : Undisclosed

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study of Continuous Heart Rate Monitoring in Healthy Participants

    Details : Propranolol is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 23, 2020

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    Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate

    Details:

    Ozanimod is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Ozanimod,Pseudoephedrine

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 23, 2018

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    10

    Bristol Myers Squibb

    U.S.A
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    Bristol Myers Squibb

    U.S.A
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    Lead Product(s) : Ozanimod,Pseudoephedrine

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Press...

    Details : Ozanimod is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 23, 2018

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    ABOUT THIS PAGE

    Looking for 90-82-4 / Pseudoephedrine API manufacturers, exporters & distributors?

    Pseudoephedrine manufacturers, exporters & distributors 1

    42

    PharmaCompass offers a list of Pseudoephedrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pseudoephedrine manufacturer or Pseudoephedrine supplier for your needs.

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

    API | Excipient name

    Pseudoephedrine

    Synonyms

    (+)-pseudoephedrine, D-pseudoephedrine, Isoephedrine, Trans-ephedrine, D-isoephedrine, Psi-ephedrin

    Cas Number

    90-82-4

    Unique Ingredient Identifier (UNII)

    7CUC9DDI9F

    About Pseudoephedrine

    A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

    Decofed Manufacturers

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

    Decofed Suppliers

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

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

    Decofed USDMF

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

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

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

    Decofed 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 Decofed as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Decofed GMP

    Decofed 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 Decofed GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Decofed GMP manufacturer or Decofed GMP API supplier for your needs.

    Decofed CoA

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

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

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