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    Chemistry

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    Also known as: 14611-52-0, Eldepryl, Selegiline hcl, Zelapar, L-deprenyl hydrochloride, (-)-deprenyl hydrochloride
    Molecular Formula
    C13H18ClN
    Molecular Weight
    223.74  g/mol
    InChI Key
    IYETZZCWLLUHIJ-UTONKHPSSA-N
    FDA UNII
    6W731X367Q
    Selegiline Hydrochloride
    A selective, irreversible inhibitor of Type B monoamine oxidase that is used for the treatment of newly diagnosed patients with PARKINSON DISEASE, and for the treatment of depressive disorders. The compound without isomeric designation is Deprenyl.
    1 2D Structure

    Selegiline Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R)-N-methyl-1-phenyl-N-prop-2-ynylpropan-2-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H17N.ClH/c1-4-10-14(3)12(2)11-13-8-6-5-7-9-13;/h1,5-9,12H,10-11H2,2-3H3;1H/t12-;/m1./s1
    2.1.3 InChI Key
    IYETZZCWLLUHIJ-UTONKHPSSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=CC=C1)N(C)CC#C.Cl
    2.1.5 Isomeric SMILES
    C[C@H](CC1=CC=CC=C1)N(C)CC#C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    6W731X367Q
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Deprenalin

    2. Deprenil

    3. Deprenyl

    4. E 250

    5. E-250

    6. E250

    7. Eldepryl

    8. Emsam

    9. Humex

    10. Jumex

    11. L-deprenyl

    12. Selegiline

    13. Selegiline Hydrochloride, (r)-isomer

    14. Selegiline Hydrochloride, (r,s)-isomer

    15. Selegiline Hydrochloride, (s)-isomer

    16. Selegiline, (r)-isomer

    17. Selegiline, (r,s)-isomer

    18. Selegiline, (s)-isomer

    19. Selegyline

    20. Yumex

    21. Zelapar

    2.3.2 Depositor-Supplied Synonyms

    1. 14611-52-0

    2. Eldepryl

    3. Selegiline Hcl

    4. Zelapar

    5. L-deprenyl Hydrochloride

    6. (-)-deprenyl Hydrochloride

    7. L-deprenyl

    8. Ensam

    9. (r)-n-methyl-n-(1-phenylpropan-2-yl)prop-2-yn-1-amine Hydrochloride

    10. R-(-)-deprenyl Hydrochloride

    11. Jumex

    12. R-(-)-deprenyl (hydrochloride)

    13. R(-)-deprenyl Hydrochloride

    14. (r)-(-)-deprenyl Hydrochloride

    15. (-)-phenylisopropylmethylpropynylamine

    16. Otrasel

    17. 6w731x367q

    18. Nsc-759259

    19. Benzeneethanamine, N,alpha-dimethyl-n-2-propyn-1-yl-, Hydrochloride (1:1), (alphar)-

    20. Dsstox_cid_24584

    21. Dsstox_rid_80331

    22. Jumex Hydrochloride

    23. Dsstox_gsid_44584

    24. Eldepryl Hydrochloride

    25. Zydis Selegiline

    26. (2r)-n-methyl-1-phenyl-n-prop-2-ynylpropan-2-amine;hydrochloride

    27. Chebi:9087

    28. (-)-deprenil Hydrochloride

    29. (-)-e-250 Hydrochloride

    30. Smr000449328

    31. Selegiline Hydrochloride [usan]

    32. Hsdb 7183

    33. Fpf1100

    34. Sr-01000597928

    35. Plurimen

    36. Seledat

    37. Vivapryl

    38. Xilopar

    39. Ccris 8571

    40. Unii-6w731x367q

    41. Eldepryl (tn)

    42. Prestwick_846

    43. (r)-deprenyl Hcl

    44. Selegiline Hydrochloride [usan:usp]

    45. (-)-(r)-n,alpha-dimethyl-n-2-propynylphenethylamine Hydrochloride

    46. (-)-n,alpha-dimethyl-n-2-propynylbenzeneethanamine Hydrochloride

    47. Ncgc00016708-01

    48. (-)-(r)-n,alpha-dimethyl-n-2-propynylphenethylamine Monohydrochloride

    49. Cas-14611-52-0

    50. R-(-)deprenyl Hydrochloride

    51. Schembl41392

    52. (-)-selegiline Hydrochloride

    53. Mls000758294

    54. Mls001423947

    55. Mls002153281

    56. Mls002222269

    57. Chembl1200904

    58. Dtxsid9044584

    59. Hms1569p05

    60. Fpf-1100

    61. Selegiline Hydrochloride (jan/usp)

    62. Tox21_110572

    63. Tox21_301846

    64. (r)-(-)-n,alpha-dimethyl-n-(2-propynyl)phenethylamine Hydrochloride

    65. Mfcd00069299

    66. Selegiline Hydrochloride [mi]

    67. Selegiline Hydrochloride [jan]

    68. Akos005166822

    69. Benzeneethanamine, N,.alpha.-dimethyl-n-2-propynyl-, Hydrochloride, (r)-

    70. Benzeneethanamine, N,alpha-dimethyl-n-2-propynyl-, Hydrochloride, (r)-

    71. Tox21_110572_1

    72. Ccg-100773

    73. Ks-5098

    74. Nc00023

    75. Nc00605

    76. Nsc 759259

    77. Selegiline Hydrochloride [hsdb]

    78. Selegiline Hydrochloride [mart.]

    79. Selegiline Hydrochloride [vandf]

    80. Ncgc00024994-06

    81. Ncgc00255797-01

    82. Selegiline Hydrochloride [usp-rs]

    83. Selegiline Hydrochloride [who-dd]

    84. Ac-18759

    85. Hy-14199

    86. Selegiline Hydrochloride [green Book]

    87. Selegiline Hydrochloride [orange Book]

    88. D00785

    89. Selegiline Hydrochloride [ep Monograph]

    90. Selegiline Hydrochloride [usp Monograph]

    91. 611s520

    92. Sr-01000597928-1

    93. Sr-01000597928-5

    94. Sr-01000597928-6

    95. Q27108267

    96. R-(-)-deprenyl Hydrochloride, Powder, >=98% (hplc)

    97. Selegiline Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    98. (r)-(-)-n,alpha-dimethyl-n-(2-propynyl)phenethylamine Hcl

    99. (r)-(-)-n-?-dimethyl-n-2-propynylbenzeneethanamine Hydrochloride

    100. (r)-n-methyl-1-phenyl-n-prop-2-ynylpropan-2-amine Hydrochloride

    101. (-)-(r)-n,.alpha.-dimethyl-n-2-propynylphenethylamine Hydrochloride

    102. Selegiline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    103. Benzeneethanamine, N,?-dimethyl-n-2-propyn-1-yl-, Hydrochloride (1:1), (?r)-

    104. Selegiline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 223.74 g/mol
    Molecular Formula C13H18ClN
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count4
    Exact Mass223.1127773 g/mol
    Monoisotopic Mass223.1127773 g/mol
    Topological Polar Surface Area3.2 Ų
    Heavy Atom Count15
    Formal Charge0
    Complexity195
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameEldepryl
    Drug LabelELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylami...
    Active IngredientSelegiline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanySomerset

    2 of 6  
    Drug NameSelegiline hydrochloride
    PubMed HealthSelegiline (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelSelegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydroch...
    Active IngredientSelegiline hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyApotex; Stason; Dava Pharms; Mylan

    3 of 6  
    Drug NameZelapar
    PubMed HealthSelegiline
    Drug ClassesAntidepressant, Antiparkinsonian
    Drug LabelZELAPAR Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenthylamine. Selegiline hydrochloride is described chemically as: (-)-(R)-N, -dimethyl-N-2-propynylphenethylamine hydrochloride and it...
    Active IngredientSelegiline hydrochloride
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength1.25mg
    Market StatusPrescription
    CompanyValeant Pharm Intl

    4 of 6  
    Drug NameEldepryl
    Drug LabelELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylami...
    Active IngredientSelegiline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanySomerset

    5 of 6  
    Drug NameSelegiline hydrochloride
    PubMed HealthSelegiline (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelSelegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydroch...
    Active IngredientSelegiline hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyApotex; Stason; Dava Pharms; Mylan

    6 of 6  
    Drug NameZelapar
    PubMed HealthSelegiline
    Drug ClassesAntidepressant, Antiparkinsonian
    Drug LabelZELAPAR Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenthylamine. Selegiline hydrochloride is described chemically as: (-)-(R)-N, -dimethyl-N-2-propynylphenethylamine hydrochloride and it...
    Active IngredientSelegiline hydrochloride
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength1.25mg
    Market StatusPrescription
    CompanyValeant Pharm Intl

    4.2 Therapeutic Uses

    Monamine oxidase B inhibitor

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1512

    Selegiline is indicated for use with levodopa or levodopa and carbidopa combination in the treatment of idiopathic Parkinson's disease (paralysis agitans). /Included in US product labeling/ /Selegiline/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    .... we report briefly on neurotoxicity associated with the immunodeficiency virus and discuss the effects of selegiline, a monoamine oxidase inhibitor which enhances dopamine availability in CNS on immunodeficiency virus-induced neurological disease. ... /MAO inhibitors may be potent mediators of the neuropathological deficits in immunodeficiency virus infection and factors which may accelerate the progression of the immunodeficiency virus --neurological disease./

    PMID:14697901 Koutsilieri E et al; Neurotoxicology 25 (1-2): 267-70 (2004)

    EXPTL Therapy: ... Twenty patients with mild-moderate pathological cerebral involution of atrophic and/or vascular origin, were treated with Selegiline (L-deprenyl), a monoamino-oxidase B inhibitor (10 mg/day for six months). Compared with a control group, Selegiline treated patients showed a statistically significant improvement in cognitive and behaviour capacities. At the end of investigation, "Mini Mental State" showed an improvement of 26.5% in Selegiline group and of 3.7% in control group (P < 0.01). "Echelle Clinique d'Aptitudes Intellectuelles" showed an improvement of 29.4% and of 10.8% respectively (P < 0.01). Selegiline treatment has shortened significantly the reaction times and has improved mnesic capacities. No side effects were observed during the study. /Selegiline/

    PMID:12645393 Bettini R, Gorini M; Clin Ter 153 (6): 377-80 (2002)

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

    4.3 Drug Warning

    Pregnancy risk category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 3176

    Selegiline may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2443

    Therapeutic use may lead to increased tremor, bradykinesia, falling, dystonic symptoms, dyskinesias, hallucinations, confusion, sleep disturbance, headache, dry mouth, blurred vision, orthostatic hypotension, hypertension, poor appetite, urinary retention, and diaphoresis. Hypomanic behavior may be due to the l-amphetamine and l-amphetamine metabolites of selegiline.

    Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997., p. 659

    In patients receiving levodopa, addition of selegiline hydrochloride may exacerbate levodopa-associated dyskinesias. This effect, which occurred in an average of 28% (range: 4-90%) of patients receiving the drug in clinical trials, usually occurs within 2 weeks after initiating selegiline therapy and generally is mitigated when the levodopa dosage is reduced ... . Involuntary movements, increased tremor, chorea, loss of balance, freezing, blepharospasm, increased bradykinesia, facial grimacing, speech problems, heavy leg, stiff neck, tardive dyskinesia, dystonic manifestations, festination, increased apraxia, and muscle cramping may occur in patients receiving selegiline. Bruxism, muscle twitching and myoclonic jerks have occurred in patients receiving levodopa and selegiline hydrochloride dosages exceeding 10 mg daily.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2439

    For more Drug Warnings (Complete) data for SELEGILINE HYDROCHLORIDE (12 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antidepressive Agents

    Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

    Monoamine Oxidase Inhibitors

    A chemically heterogeneous group of drugs that have in common the ability to block oxidative deamination of naturally occurring monoamines. (From Gilman, et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed, p414) (See all compounds classified as Monoamine Oxidase Inhibitors.)

    Neuroprotective Agents

    Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)

    Antiparkinson Agents

    Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Monoamine Oxidase Inhibitors [MoA]; Monoamine Oxidase Type B Inhibitor [EPC]; Monoamine Oxidase-B Inhibitors [MoA]; Monoamine Oxidase Inhibitor [EPC]
    5.3 Absorption, Distribution and Excretion

    Selegiline and its metabolites are widely distributed into body tissues and cross the blood-brain barrier. Following IV administration of radiolabeled selegiline hydrochloride in mice, the parent drug and/or metabolites are rapidly and widely distributed to brain, liver, kidney, lung, heart, and brown fat. Following IV administration of radiolabeled selegiline hydrochloride in healthy adults, the highest accumulation of radioactivity occurred in the thalamus, basal ganglia, mesencephalon, and cingulate gyrus. /Selegiline/

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2441

    Selegiline is excreted principally in urine as conjugated and unconjugated metabolites. About 20-63% of an orally administered dose of selegiline is excreted in urine as l-methamphetamine, 9-26% as l-amphetamine, and 1% as l-demethylselegiline. ... About 15% of a dose is excreted in feces within 72 hours following administration of selegiline. /SRP: This would usually result in a false positive drug test for d-methamphetamine if no d/l-isomer characterization was performed on the specimen./ /Selegiline/

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2441

    Rapidly absorbed from the gastrointestinal tract.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    ... The mean peak plasma concentration (Cmax) is approximately 2 ug/L and the time to reach the peak is under an hour. The absolute bioavailability of selegiline is approximately 10%. It has an apparent volume of distribution of 1854 L. The oral clearance of selegiline (59 L/min) is many fold higher than the liver blood flow (1.5 L/min), indicating that extrahepatic processes are involved in the elimination of selegiline. ... /Selegiline/

    PMID:9260033 Mahmood I; Clin Pharmacokinet 33 (2): 91-102 (1997)

    ... Selegiline is readily absorbed from the gastrointestinal tract and rapidly enters the brain and spinal cord following oral administration. The drug binds to brain regions with a high MAO-B content, such as the thalamus, the striatum, the cortex, and the brainstem. ... /Selegiline/

    Gerlach M et al; Neurology 47 (6 Suppl 3): S137-45 (1996)

    5.4 Metabolism/Metabolites

    Selegiline is excreted principally in urine as conjugated and unconjugated metabolites. About 20-63% of an orally administered dose of selegiline is excreted in urine as l-methamphetamine, 9-26% as l-amphetamine, and 1% as l-demethylselegiline. /Selegiline/

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2441

    Rapidly and completely metabolized to N-desmethyldeprenyl, l-methamphetamine, and l-amphetamine.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    Selegiline is extensively metabolized, presumably through cytochrome p450 mediated oxygenation, to form l-desmethylselegiline and l-methamphetamine, which is further metabolized to l-amphetamine. Selegiline also is metabolized in the lungs to l-desmethylselegiline and l-methamphetamine and in the kidneys to l-methamphetamine, but the degree of metabolism in these tissues is minimal compared with that in the liver. /Selegiline/

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2441

    ... The pharmacokinetics of selegiline are highly variable. Following an oral dose of selegiline 10 mg, it is rapidly absorbed and metabolized to desmethylselegiline, levoamphetamine and levomethamphetamine. /Selegiline/

    PMID:9260033 Mahmood I; Clin Pharmacokinet 33 (2): 91-102 (1997)

    For more Metabolism/Metabolites (Complete) data for SELEGILINE HYDROCHLORIDE (6 total), please visit the HSDB record page.

    5.5 Biological Half-Life

    Elimination: Selegiline: 39 (range, 16 to 69) hours. /Selegiline/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    The mean half-lives of the 3 active metabolites that were found in serum and urine following a single dose of selegiline are as follows: N-desmethyldeprenyl, 2 hours; l-amphetamine, 17.7 hours; l-methamphetamine, 20.5 hours. /Selegiline/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    5.6 Mechanism of Action

    The action of selegiline is thought to be related to its irreversible inhibition of monoamine oxidase type B (MAO B), the major form of the enzyme in the human brain. MAO B, which is involved in the oxidative deamination of dopamine in the brain, is inhibited when selegiline binds covalently and stoichiometrically to the isoalloxazine flavin adenine dinucleotide (FAD) at its active center. Administration of 10 mg of selegiline a day produces almost complete inhibition of MAO B in the brain. Selegiline becomes a nonselective inhibitor of all monamine oxidase (MAO) at higher doses, possibly at 20 to 40 mg a day. At these doses, tyramine-mediated hypertensive reaction with MAO A blockade ("cheese reactions") may occur. /Selegiline/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    Selegiline (or its metabolites) may also act through other mechanisms to increase dopaminergic activity, including interfering with dopamine reuptake at the synapse. /Selegiline/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2442

    The mechanism of action of selegiline is complex and cannot be explained solely by its MAO-B inhibitory action. Pretreatment with selegiline can protect neurons against a variety of neurotoxins, such as 1-methyl-4-phenyl-1,2,3,6 tetrahydropyridine (MPTP), 6-hydroxydopamine, N-(2-chloroethyl)-N-ethyl-2-bromobenzylamine (DSP-4), methyl-beta-acetoxyethyl-2-chloroethylamine (AF64A), and 5,6-dihydroxyserotonin, which damage dopaminergic, adrenergic, cholinergic, and sertoninergic neurons, respectively. Selegiline produces an amphetamine-like effect, enhances the release of dopamine, and blocks the reuptake of dopamine. It stimulates gene expression of L-aromatic amino acid decarboxylase, increases striatal phenylethylamine levels, and activates dopamine receptors. Selegiline reduces the production of oxidative radicals, up-regulates superoxide dismutase and catalase, and suppresses nonenzymatic and iron-catalyzed autooxidation of dopamine. Selegiline compensates for loss of target-derived trophic support, delays apoptosis in serum-deprived cells, and blocks apoptosis-related fall in the mitochondrial membrane potential. Most of the aforementioned properties occur independently of selegiline's efficacy to inhibit MAO-B. /Selegiline/

    PMID:11813232 Ebadi M et al; J Neurosci Res 67 (3): 285-9 (2002)

    Selegiline is a selective inhibitor of monoamine oxidase-B (MAO-B) at a dose of 10 mg/day and is given to patients with Parkinson's disease as an adjunct to levodopa therapy. By inhibiting MAO-B, selegiline increases the dopamine levels in the substantia nigra. Selegiline also blocks dopamine re-uptake from the synaptic cleft, thus increasing the dopamine concentrations in the brain. ... /Selegiline/

    PMID:9260033 Mahmood I; Clin Pharmacokinet 33 (2): 91-102 (1997)

    For more Mechanism of Action (Complete) data for SELEGILINE HYDROCHLORIDE (6 total), please visit the HSDB record page.

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MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705948200,"product":"SELEGILINE BATCH NO SLGN\/22\/01\/22 MFG JANUARY 2022 RETEST JULY 2024","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"MEMPHIS","customer":"N\/A","customerCountry":"UNITED STATES","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"20750","totalValueFC":"19816.7","currency":"USD","unitRateINR":1647000,"date":"23-Jan-2024","totalValueINR":"1647000","totalValueInUsd":"19816.7","indian_port":"Bombay Air","hs_no":"29214990","bill_no":"6963588","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"PHARMACEUTICAL RAW MATERIAL\/BULK DRUGS SELEGILINE HCL USP","address":"309 HARIKRUPA TOWER NR.OLD-","city":"AHMEDABAD","supplier":"JAI RADHE SALES","supplierCountry":"INDIA","foreign_port":"BEIRUT","customer":"TO THE ORDER OF","customerCountry":"LEBANON","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"889","totalValueFC":"4259.9","currency":"USD","unitRateINR":70692,"date":"02-Feb-2024","totalValueINR":"353460","totalValueInUsd":"4259.9","indian_port":"Ahmedabad Air","hs_no":"29211990","bill_no":"7233866","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"LEBANON","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"309 HARIKRUPA TOWER NR.OLD-, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708713000,"product":"SELEGILINE HYDROCHLORIDE PHARMA. EUR BATCH NO. 7101223 MFG.DT. JULY 2023. EXP\/RETEST DT. JUNE 2028","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"TO THE ORDER","customerCountry":"CYPRUS","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1275","totalValueFC":"12551.2","currency":"USD","unitRateINR":104141.8,"date":"24-Feb-2024","totalValueINR":"1041418","totalValueInUsd":"12551.2","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"7795117","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710354600,"product":"SELEGILINE HYDROCHLORIDE USP BATCH NO:7100923 MFG DT.JANUARY 2023 EXP.\/RETEST DT.DECEMBER 2027","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"CINCINNATI, OH","customer":"TO THE ORDER OF","customerCountry":"UNITED STATES","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1600","totalValueFC":"4533.4","currency":"USD","unitRateINR":125478.86,"date":"14-Mar-2024","totalValueINR":"376436.58","totalValueInUsd":"4533.4","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"8318968","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"SELEGILINE HYDROCHLORIDE USP BATCH NO:7101323 MFG DT:AUGUST 2023 EXP\/RETEST DT.JULY 2028","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"LIMA -","customer":"TO THE ORDER OF","customerCountry":"PERU","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1240","totalValueFC":"1156.7","currency":"USD","unitRateINR":96411.809999999998,"date":"09-May-2024","totalValueINR":"96411.81","totalValueInUsd":"1156.7","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"9734656","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PERU","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715279400,"product":"SELEGILINE HYDROCHLORIDE USP BATCH NO:7101623 MFG DT:AUGUST 2023 EXP\/RETEST DT.JULY 2028","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"TO THE ORDER OF","customerCountry":"SWITZERLAND","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"1400.9","totalValueFC":"5456.1","currency":"USD","unitRateINR":113696.4225,"date":"10-May-2024","totalValueINR":"454785.69","totalValueInUsd":"5456.1","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"9790625","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:2024010490 DT:08.07.2024) SELEGILINE HYDROCHLORIDE USP NF 2024","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1248","totalValueFC":"2472.4","currency":"USD","unitRateINR":103334.41,"date":"22-Jul-2024","totalValueINR":"206668.82","totalValueInUsd":"2472.4","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"2592188","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724437800,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:2024010664 DT:10.08.2024) SELEGILINE HYDROCHLORIDE USP-NF 2024","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1100","totalValueFC":"5448.9","currency":"USD","unitRateINR":91409.971999999994,"date":"24-Aug-2024","totalValueINR":"457049.86","totalValueInUsd":"5448.9","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"3461697","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726165800,"product":"SELEGILINE HYDROCHLORIDE USP. BATCH NO.7101723 MFG.DT. AUGUST 2023. EXP\/RETESTDT. JULY 2028","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"TO THE ORDER","customerCountry":"THAILAND","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1200","totalValueFC":"3507.1","currency":"USD","unitRateINR":97965.113333333342,"date":"13-Sep-2024","totalValueINR":"293895.34","totalValueInUsd":"3507.1","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"3997067","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726770600,"product":"SELEGILINE HYDROCHLORIDE USP","address":"306, SAI CHAMBERS,","city":"MUMBAI","supplier":"TENATRA EXPORTS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"QFSA","customerCountry":"GUATEMALA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1280","totalValueFC":"6029","currency":"USD","unitRateINR":101047.208,"date":"20-Sep-2024","totalValueINR":"505236.04","totalValueInUsd":"6029","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"4208048","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"306, SAI CHAMBERS,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"SELEGILINE HYDROCHLORIDE USP, BATCH NO: 7101723, MFG DT: AUGUST 2023, EXP\/RETEST: JULY 2028","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"CINCINNATI, OH","customer":"TO THE ORDER OF","customerCountry":"UNITED STATES","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"1500","totalValueFC":"5800.6","currency":"USD","unitRateINR":121852.015,"date":"21-Oct-2024","totalValueINR":"487408.06","totalValueInUsd":"5800.6","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"4995010","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"BULK DRUG SELEGILINE BATCH NO SLGN\/24\/10\/02 (QTY 1KGS)","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"MIAMI, FL","customer":"CORIUM INNOVATIONS INC","customerCountry":"UNITED STATES","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"25821","totalValueFC":"19777.7","currency":"USD","unitRateINR":1669000,"date":"14-Nov-2024","totalValueINR":"1669000","totalValueInUsd":"19777.7","indian_port":"Ahmedabad Air","hs_no":"29214990","bill_no":"5606540","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"SELEGILINE ( QTY 0.020 KGS) BATCH NO:SEGN\/24\/10\/02","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M\/S RICON PHARMA LLC","customerCountry":"UNITED STATES","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"115500","totalValueFC":"198.1","currency":"USD","unitRateINR":836000,"date":"28-Nov-2024","totalValueINR":"16720","totalValueInUsd":"198.1","indian_port":"Ahmedabad Air","hs_no":"29214990","bill_no":"5995421","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"WE INTEND TO CLAIM REWARDS UNDER MERCHANDISE EXPORT FROM INDIA SCHEME MFG BY : EMBIO LIMITED : SELEGILINE HCL","address":"D\/607 SAHAR PLAZA, BLDG-3, A TO H,","city":"ANDHERI EAST,MAHARASHTRA","supplier":"OCEANIC PHARMACHEM","supplierCountry":"INDIA","foreign_port":"SOFIA","customer":"TO THE ORDER","customerCountry":"BULGARIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"1595","totalValueFC":"12452.4","currency":"USD","unitRateINR":132258.5,"date":"05-Dec-2024","totalValueINR":"1058068","totalValueInUsd":"12452.4","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"6208186","productDescription":"API","marketType":"REGULATED MARKET","country":"BULGARIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"D\/607 SAHAR PLAZA, BLDG-3, A TO H,, ANDHERI EAST,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713292200,"product":"RE-IMPORT-SELEGILINE HYDROCHLORIDE PHARM EUR ,BATCH NO.7100723 \/7100423,MFG DT JANUARY 2023\/EXP. DT.DECEMBER 2027,DBK AN","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"ORION CORPORATION","supplierCountry":"INDIA","foreign_port":"HELSINKI","customer":"EMBIO LIMITED","customerCountry":"INDIA","quantity":"10.76","actualQuantity":"10.76","unit":"KGS","unitRateFc":"0.9","totalValueFC":"12.2","currency":"USD","unitRateINR":"95","date":"17-Apr-2024","totalValueINR":"1021.69","totalValueInUsd":"12.2","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"3061720","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"TENGSTROMINKATU 8 , 20360 TURKU FINLANDSDNF FINLAND","customerAddress":"501, SENTINEL, HIRANANDANI GARDENS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"SELEGILINE BATCH NO SLGN\/22\/01\/02 (S.B NO. 8100710 DT 09.02.2022) (RE-IMPORT DUE TO REJECTION)","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"RICONPHARMA LLC","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"VIATRIS","customerCountry":"INDIA","quantity":"9.89","actualQuantity":"9.89","unit":"KGS","unitRateFc":"2500","totalValueFC":"24923.2","currency":"USD","unitRateINR":"214125","date":"07-Dec-2024","totalValueINR":"2117696.25","totalValueInUsd":"24923.2","indian_port":"Bombay Air","hs_no":"29214990","bill_no":"7108276","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"100 FORD ROAD SUITE #9, DENVILLE NJ 7834 SDNF UNITED STATES","customerAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE"}]
    02-Feb-2021
    07-Dec-2024
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    ABOUT THIS PAGE

    Selegiline Hydrochloride Manufacturers

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

    Selegiline Hydrochloride Suppliers

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

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

    Selegiline Hydrochloride USDMF

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

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

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

    Selegiline Hydrochloride 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 Selegiline Hydrochloride Drug Master File in Japan (Selegiline Hydrochloride JDMF) empowers Selegiline Hydrochloride 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 Selegiline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Selegiline Hydrochloride 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 Selegiline Hydrochloride suppliers with JDMF on PharmaCompass.

    Selegiline Hydrochloride KDMF

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

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

    After submitting a Selegiline Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Selegiline Hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

    Selegiline Hydrochloride CEP

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

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

    Selegiline Hydrochloride WC

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

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

    Selegiline Hydrochloride 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 Selegiline Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Selegiline Hydrochloride GMP

    Selegiline Hydrochloride 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 Selegiline Hydrochloride 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 Selegiline Hydrochloride GMP manufacturer or Selegiline Hydrochloride GMP API supplier for your needs.

    Selegiline Hydrochloride CoA

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

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

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