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Chemistry

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Also known as: Hyoscine, (-)-hyoscine, 51-34-3, Scopine (-)-tropate, Scopine tropate, (-)-scopolamine
Molecular Formula
C17H21NO4
Molecular Weight
303.35  g/mol
InChI Key
STECJAGHUSJQJN-USLFZFAMSA-N
FDA UNII
DL48G20X8X

Scopolamine
An alkaloid from SOLANACEAE, especially DATURA and SCOPOLIA. Scopolamine and its quaternary derivatives act as antimuscarinics like ATROPINE, but may have more central nervous system effects. Its many uses include an anesthetic premedication, the treatment of URINARY INCONTINENCE and MOTION SICKNESS, an antispasmodic, and a mydriatic and cycloplegic.
Scopolamine is an Anticholinergic. The mechanism of action of scopolamine is as a Cholinergic Antagonist.
1 2D Structure

Scopolamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(1R,2R,4S,5S)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] (2S)-3-hydroxy-2-phenylpropanoate
2.1.2 InChI
InChI=1S/C17H21NO4/c1-18-13-7-11(8-14(18)16-15(13)22-16)21-17(20)12(9-19)10-5-3-2-4-6-10/h2-6,11-16,19H,7-9H2,1H3/t11?,12-,13-,14+,15-,16+/m1/s1
2.1.3 InChI Key
STECJAGHUSJQJN-USLFZFAMSA-N
2.1.4 Canonical SMILES
CN1C2CC(CC1C3C2O3)OC(=O)C(CO)C4=CC=CC=C4
2.1.5 Isomeric SMILES
CN1[C@@H]2CC(C[C@H]1[C@H]3[C@@H]2O3)OC(=O)[C@H](CO)C4=CC=CC=C4
2.2 Other Identifiers
2.2.1 UNII
DL48G20X8X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Boro Scopol

2. Boro-scopol

3. Hyoscine

4. Isopto Hyoscine

5. Kwells

6. Scoburen

7. Scopace

8. Scopoderm Tts

9. Scopolamine Cooper

10. Scopolamine Hydrobromide

11. Transderm Scop

12. Transderm V

13. Transderm-v

14. Travacalm Ho

15. Vorigeno

2.3.2 Depositor-Supplied Synonyms

1. Hyoscine

2. (-)-hyoscine

3. 51-34-3

4. Scopine (-)-tropate

5. Scopine Tropate

6. (-)-scopolamine

7. 6,7-epoxytropine Tropate

8. Hyosol

9. Atrochin

10. Atroquin

11. Isopto Hyoscine

12. Skopolamin

13. Transderm-scop

14. L-scopolamine

15. Epoxytropine Tropate

16. Scopolamine Hydrobromide

17. 6-beta,7-beta-epoxy-3-alpha-tropanyl S-(-)-tropate

18. Beldavrin

19. Scopamin

20. Kwells

21. Alpha-(hydroxymethyl)benzeneacetic Acid 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(2.4))non-7-yl Ester

22. Hyosceine

23. Scop

24. Dl48g20x8x

25. Tropic Acid, Ester With Scopine

26. Chembl3084722

27. Chebi:16794

28. Euscopol

29. Isoscopil

30. Tranaxine

31. (1s,3s,5r,6r,7s)-6,7-epoxytropan-3-yl (2s)-3-hydroxy-2-phenylpropanoate

32. Hysco

33. Hyoscine Bromide

34. Scopace

35. Transderm Scop

36. Scopolamine Hcl

37. Boro-scopol

38. Hyoscine Hydrobromide

39. Scopolaminium Bromide

40. 1alphah,5alphah-tropan-3alpha-ol, 6beta,7beta-epoxy-, (-)-tropate (ester)

41. Scopolammonium Bromide

42. L-hyoscine Hydrobromide

43. See

44. (-)-scopolamine Bromide

45. L-scopolamine-hydrobromide

46. Scopolamine Bromide

47. (-)-hyoscine Hydrobromide

48. Scopoderm

49. Levo-duboisine

50. (+)-hyoscine

51. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0(2,4)]non-7-yl (2s)-3-hydroxy-2-phenylpropanoate

52. Hyoscyine Hydrobromide

53. Atroscine Hydrobromide

54. Hydroscine Hydrobromide

55. Hydrobromicum, Scopolaminum

56. Unii-dl48g20x8x

57. Tropane Alkaloid

58. Hsdb 4074

59. 6.beta.,7.beta.-epoxy-1.alpha.h,5.alpha.h-tropan-3.alpha.-ol (-)-tropate (ester)

60. Einecs 200-090-3

61. Nsc61806

62. S-(-)-tropate

63. Scopolamine [mi]

64. Prestwick3_000877

65. Hyoscine [mart.]

66. Scopolamine [hsdb]

67. Hyoscine [who-dd]

68. Ec 200-090-3

69. Scopolamine [vandf]

70. 6beta,7beta-epoxy-3alpha-tropanyl S-(-)-tropate

71. Schembl16226

72. Bspbio_000953

73. Gtpl330

74. 6beta,7beta-epoxy-1alpha,5alpha-tropan-3alpha-ol

75. Hyoscine [ep Impurity]

76. Bpbio1_001049

77. Chembl569713

78. Hyoscine [ep Monograph]

79. Chembl1906925

80. Dtxsid6023573

81. Schembl22393238

82. Chebi:93572

83. Scopolamine [orange Book]

84. Hms2090n13

85. Hms3886l22

86. Scopolamine [usp Impurity]

87. Hy-n0296

88. Lsm-4015

89. Ac-968

90. Bdbm50263508

91. S9326

92. Zinc13118910

93. Akos025402477

94. Tropic Acid, 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(sup 2,4))non-7-yl Ester

95. Zinc100037020

96. Zinc101147375

97. Ccg-267504

98. Cs-6609

99. Db00747

100. 3-oxa-9-azatricyclo(3.3.1.0(sup 2,4))nonan-7-ol, 9-methyl-, Tropate (ester)

101. 3-oxa-9-azatricyclo(3.3.1.o(sup 2,4))nonan-7-ol, 9-methyl-, Tropate (ester)

102. Smp1_000270

103. Ncgc00024357-04

104. Ncgc00024357-05

105. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0~2,4~]non-7-yl (2s)-3-hydroxy-2-phenylpropanoate

106. Ab00429689

107. Ab00429689-30

108. Ab00429689-31

109. Ab00429689_32

110. Atropine Sulfate Impurity F [ep Impurity]

111. Q337188

112. (methyl[?]yl) (2s)-3-hydroxy-2-phenyl-propanoate

113. Brd-k89923877-003-02-4

114. Q27165268

115. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl (2s)-3-hydroxy-2-phenylpropanoate

116. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0^{2,4}]nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate

117. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2r)-3-hydroxy-2-phenylpropanoate

118. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate

119. (1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl (s)-3-hydroxy-2-phenylpropanoate

120. [(1r,2r,4s,5s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] (2s)-3-hydroxy-2-phenylpropanoate

121. [7(s)-(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)]-.alpha.-(hydroxymethyl)benzeneacetic Acid 9-methyl-3-oxa-9-azatricyclo-[3.3.1.0^2,4]non-7-yl Ester

122. Benzeneacetic Acid, .alpha.(hydroxymethyl)-,(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl Ester, (.alpha.s)-

123. Benzeneacetic Acid, .alpha.-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl Ester, (7(s)-(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.))-

124. Benzeneacetic Acid, Alpha-(hydroxymethyl)-, (1alpha,2beta,4beta,5alpha,7beta)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl Ester, (alphas)-

125. Benzeneacetic Acid, Alpha-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl Ester, (7(s)-(1alpha,2beta,4beta,5alpha,7beta))-

2.3.3 Other Synonyms

1. Scopolamine Sulfate

2. Scopolamine Sulphate

2.4 Create Date
2005-06-29
3 Chemical and Physical Properties
Molecular Weight 303.35 g/mol
Molecular Formula C17H21NO4
XLogP30.9
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count5
Exact Mass303.14705815 g/mol
Monoisotopic Mass303.14705815 g/mol
Topological Polar Surface Area62.3 Ų
Heavy Atom Count22
Formal Charge0
Complexity418
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Adjuvants, Anesthesia; Antiemetics; Muscarinic Antagonists; Mydriatics; Parasympatholytics

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Although transdermal scopolamine has been shown to decrease basal acid output and inhibit betazole-, pentagastrin-, and peptone-stimulated gastric acid secretion in healthy individuals, it has not been determined whether transdermal scopolamine is effective in the adjunctive treatment of peptic ulcer disease. /Use is not currently included in the labeling approved by the US FDA/

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1321


Transdermal scopolamine has shown minimal antiemetic activity against chemotherapy-induced vomiting. /Use is not currently included in the labeling approved by the US FDA/

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1321


Scopolamine hydrobromide is used as a mydriatic and cycloplegic, especially when the patient is sensitive to atropine or when less prolonged cycloplegia is required. The effects of the drug appear more rapidly and have a shorter duration of action than those of atropine. Scopolamine hydrobromide is also used in the management of acute inflammatory conditions (i.e., iridocyclitis) of the iris and uveal tract. /Scopolamine hydrobromide/

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 2912


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


4.2 Drug Warning

The use of scopolamine to produce tranquilization and amnesia in a variety of circumstances, including labor, is declining and of questionable value. Given alone in the presence of pain or severe anxiety, scopolamine may induce outbursts of uncontrolled behavior.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill, 2006., p. 197


Scopolamine in therapeutic doses normally causes CNS depression manifested as drowsiness, amnesia, fatigue, and dreamless sleep, with a reduction in rapid eye movement (REM) sleep. It also causes euphoria and is therefore subject to some abuse. The depressant and amnesic effects formerly were sought when scopolamine was used as an adjunct to anesthetic agents or for preanesthetic medication. However, in the presence of severe pain, the same doses of scopolamine can occasionally cause excitement, restlessness, hallucinations, or delirium. These excitatory effects resemble those of toxic doses of atropine.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill, 2006., p. 191-2


Scopolamine-induced inhibition of salivation occurs within 30 minutes or within 30 minutes to 1 hour and peaks within 1 or 1-2 hours after IM or oral administration, respectively; inhibition of salivation persists for up to 4-6 hours. Following IV administration of a 0.6-mg dose in one study, amnesia occurred within 10 minutes, peaked between 50-80 minutes, and persisted for at least 120 minutes after administration. Following IM administration of a 0.2-mg dose of scopolamine in one study, antiemetic effect occurred within 15-30 minutes and persisted for about 4 hours. Following IM administration of a 0.1- or 0.2-mg dose in another study, mydriasis persisted for up to 8 hours. The transdermal system is designed to provide an antiemetic effect with an onset of about 4 hours and with a duration of up to 72 hours after application.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


Small doses of ... scopolamine inhibit the activity of sweat glands innervated by sympathetic cholinergic fibers, and the skin becomes hot and dry. Sweating may be depressed enough to raise the body temperature, but only notably so after large doses or at high environmental temperatures.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill, 2006., p. 194


For more Drug Warnings (Complete) data for SCOPOLAMINE (21 total), please visit the HSDB record page.


4.3 Drug Indication

Scopolamine is indicated in adult patients for the prevention of nausea and vomiting associated with motion sickness and for the prevention of postoperative nausea and vomiting (PONV) associated with anesthesia or opiate analgesia.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Scopolamine is an anticholinergic belladonna alkaloid that, through competitive inhibition of muscarinic receptors, affects parasympathetic nervous system function and acts on smooth muscles that respond to acetylcholine but lack cholinergic innervation. Formulated as a patch, scopolamine is released continuously over three days and remains detectable in urine over a period of 108 hours. Scopolamine is contraindicated in angle-closure glaucoma and should be used with caution in patients with open-angle glaucoma due to scopolamine's ability to increase intraocular pressure. Also, scopolamine exhibits several neuropsychiatric effects: exacerbated psychosis, seizures, seizure-like, and other psychiatric reactions, and cognitive impairment; scopolamine may impair the ability of patients to operate machinery or motor vehicles, play underwater sports, or perform any other potentially hazardous activity. Women with severe preeclampsia should avoid scopolamine. Patients with gastrointestinal or urinary disorders should be monitored frequently for impairments, and scopolamine should be discontinued if these develop. Scopolamine can cause blurred vision if applied directly to the eye, and the transdermal patch should be removed before an MRI procedure to avoid skin burns. Due to its gastrointestinal effects, scopolamine can interfere with gastric secretion testing and should be discontinued at least 10 days before performing the test. Finally, scopolamine may induce dependence and resulting withdrawal symptoms, such as nausea, dizziness, vomiting, gastrointestinal disturbances, sweating, headaches, bradycardia, hypotension, and various neuropsychiatric manifestations following treatment discontinuation; severe symptoms may require medical attention.


5.2 MeSH Pharmacological Classification

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)


Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)


Cholinergic Antagonists

Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)


Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)


Mydriatics

Agents that dilate the pupil. They may be either sympathomimetics or parasympatholytics. (See all compounds classified as Mydriatics.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
SCOPOLAMINE
5.3.2 FDA UNII
DL48G20X8X
5.3.3 Pharmacological Classes
Cholinergic Antagonists [MoA]; Anticholinergic [EPC]
5.4 ATC Code

A04AD01

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


A - Alimentary tract and metabolism

A04 - Antiemetics and antinauseants

A04A - Antiemetics and antinauseants

A04AD - Other antiemetics

A04AD01 - Scopolamine


N - Nervous system

N05 - Psycholeptics

N05C - Hypnotics and sedatives

N05CM - Other hypnotics and sedatives

N05CM05 - Scopolamine


S - Sensory organs

S01 - Ophthalmologicals

S01F - Mydriatics and cycloplegics

S01FA - Anticholinergics

S01FA02 - Scopolamine


5.5 Absorption, Distribution and Excretion

Absorption

The pharmacokinetics of scopolamine differ substantially between different dosage routes. Oral administration of 0.5 mg scopolamine in healthy volunteers produced a Cmax of 0.54 0.1 ng/mL, a tmax of 23.5 8.2 min, and an AUC of 50.8 1.76 ng\*min/mL; the absolute bioavailability is low at 13 1%, presumably because of first-pass metabolism. By comparison, IV infusion of 0.5 mg scopolamine over 15 minutes resulted in a Cmax of 5.00 0.43 ng/mL, a tmax of 5.0 min, and an AUC of 369.4 2.2 ng\*min/mL. Other dose forms have also been tested. Subcutaneous administration of 0.4 mg scopolamine resulted in a Cmax of 3.27 ng/mL, a tmax of 14.6 min, and an AUC of 158.2 ng\*min/mL. Intramuscular administration of 0.5 scopolamine resulted in a Cmax of 0.96 0.17 ng/mL, a tmax of 18.5 4.7 min, and an AUC of 81.3 11.2 ng\*min/mL. Absorption following intranasal administration was found to be rapid, whereby 0.4 mg of scopolamine resulted in a Cmax of 1.68 0.23 ng/mL, a tmax of 2.2 3 min, and an AUC of 167 20 ng\*min/mL; intranasal scopolamine also had a higher bioavailability than that of oral scopolamine at 83 10%. Due to dose-dependent adverse effects, the transdermal patch was developed to obtain therapeutic plasma concentrations over a longer period of time. Following patch application, scopolamine becomes detectable within four hours and reaches a peak concentration (tmax) within 24 hours. The average plasma concentration is 87 pg/mL, and the total levels of free and conjugated scopolamine reach 354 pg/mL.


Route of Elimination

Following oral administration, approximately 2.6% of unchanged scopolamine is recovered in urine. Compared to this, using the transdermal patch system, less than 10% of the total dose, both as unchanged scopolamine and metabolites, is recovered in urine over 108 hours. Less than 5% of the total dose is recovered unchanged.


Volume of Distribution

The volume of distribution of scopolamine is not well characterized. IV infusion of 0.5 mg scopolamine over 15 minutes resulted in a volume of distribution of 141.3 1.6 L.


Clearance

IV infusion of 0.5 mg scopolamine resulted in a clearance of 81.2 1.55 L/h, while subcutaneous administration resulted in a lower clearance of 0.14-0.17 L/h.


Scopolamine hydrobromide is rapidly absorbed following IM or subcutaneous injection. The drug is well absorbed from the GI tract, principally from the upper small intestine. Scopolamine also is well absorbed percutaneously. Following topical application behind the ear of a transdermal system, scopolamine is detected in plasma within 4 hours, with peak concentrations occurring within an average of 24 hours. In one study in healthy individuals, mean free and total (free plus conjugated) plasma scopolamine concentrations of 87 and 354 pg/mL, respectively, have been reported within 24 hours following topical application of a single transdermal scopolamine system that delivered approximately 1 mg/72 hours. /Scopolamine hydrobromide/

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


Following oral administration of a 0.906-mg dose of scopolamine in one individual, a peak concentration of about 2 ng/mL was reached within 1 hour. Although the commercially available transdermal system contains 1.5 mg of scopolamine, the membrane-controlled diffusion system is designed to deliver approximately 1 mg of the drug to systemic circulation at an approximately constant rate over a 72-hour period. An initial priming dose of 0.14 mg of scopolamine is released from the adhesive layer of the system at a controlled, asymptotically declining rate over 6 hours; then, the remainder of the dose is released at an approximate rate of 5 ug/hour for the remaining 66-hour functional lifetime of the system. The manufacturer states that the initial priming dose saturates binding sites on the skin and rapidly brings the plasma concentration to steady-state. In a crossover study comparing urinary excretion rates of scopolamine during multiple 12-hour collection intervals in healthy individuals, there was no difference between the rates of excretion of drug during steady-state (24-72 hours) for constant-rate IV infusion (3.7-6 mcg/hour) and transdermal administration. The transdermal system appeared to deliver the drug to systemic circulation at the same rate as the constant-rate IV infusion; however, relatively long collection intervals (12 hours) make it difficult to interpret the data precisely. During the 12- to 24-hour period of administration and after 72 hours, the rate of excretion of scopolamine was higher with the transdermal system than with the constant-rate IV infusion.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


The distribution of scopolamine has not been fully characterized. The drug appears to be reversibly bound to plasma proteins. Scopolamine apparently crosses the blood-brain barrier since the drug causes CNS effects. The drug also reportedly crosses the placenta and is distributed into milk..

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


Although the metabolic and excretory fate of scopolamine has not been fully determined, the drug is thought to be almost completely metabolized (principally by conjugation) in the liver and excreted in urine. Following oral administration of a single dose of scopolamine in one study, only small amounts of the dose (about 4-5%) were excreted unchanged in urine within 50 hours; urinary clearance of unchanged drug was about 120 mL/minute. In another study, 3.4% or less than 1% of a single dose was excreted unchanged in urine within 72 hours following subcutaneous injection or oral administration of the drug, respectively. Following application of a single transdermal scopolamine system that delivered approximately 1 mg/72 hours in healthy individuals, the urinary excretion rate of free and total (free plus conjugated) scopolamine was about 0.7 and 3.8 ug/hour, respectively. Following removal of the transdermal system of scopolamine, depletion of scopolamine bound to skin receptors at the site of the application of the transdermal system results in a log-linear decrease in plasma scopolamine concentrations. Less than 10% of the total dose is excreted in urine as unchanged drug and its metabolites over 108 hours.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


5.6 Metabolism/Metabolites

Little is known about the metabolism of scopolamine in humans, although many metabolites have been detected in animal studies. In general, scopolamine is primarily metabolized in the liver, and the primary metabolites are various glucuronide and sulphide conjugates. Although the enzymes responsible for scopolamine metabolism are unknown, _in vitro_ studies have demonstrated oxidative demethylation linked to CYP3A subfamily activity, and scopolamine pharmacokinetics were significantly altered by coadministration with grapefruit juice, suggesting that CYP3A4 is responsible for at least some of the oxidative demethylation.


Although the metabolic and excretory fate of scopolamine has not been fully determined, the drug is thought to be almost completely metabolized (principally by conjugation) in the liver and excreted in urine.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


5.7 Biological Half-Life

The half-life of scopolamine differs depending on the route. Intravenous, oral, and intramuscular administration have similar half-lives of 68.7 1.0, 63.7 1.3, and 69.1 8/0 min, respectively. The half-life is greater with subcutaneous administration at 213 min. Following removal of the transdermal patch system, scopolamine plasma concentrations decrease in a log-linear fashion with a half-life of 9.5 hours.


Following application of a single transdermal scopolamine system that delivered approximately 1 mg/72 hours, the average elimination half-life of the drug was 9.5 hours.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


5.8 Mechanism of Action

[Acetylcholine] (ACh) is a neurotransmitter that can signal through ligand-gated cation channels (nicotinic receptors) and G-protein-coupled muscarinic receptors (mAChRs). ACh signalling via mAChRs located in the central nervous system (CNS) and periphery can regulate smooth muscle contraction, glandular secretions, heart rate, and various neurological phenomena such as learning and memory. mAChRs can be divided into five subtypes, M1-M5, expressed at various levels throughout the brain. Also, M2 receptors are found in the heart and M3 receptors in smooth muscles, mediating effects apart from the direct modulation of the parasympathetic nervous system. While M1, M3, and M5 mAChRs primarily couple to Gq proteins to activate phospholipase C, M2 and M4 mainly couple to Gi/o proteins to inhibit adenylyl cyclase and modulate cellular ion flow. This system, in part, helps to control physiological responses such as nausea and vomiting. Scopolamine acts as a non-selective competitive inhibitor of M1-M5 mAChRs, albeit with weaker M5 inhibition; as such, scopolamine is an anticholinergic with various dose-dependent therapeutic and adverse effects. The exact mechanism(s) of action of scopolamine remains poorly understood. Recent evidence suggests that M1 (and possibly M2) mAChR antagonism at interneurons acts through inhibition of downstream neurotransmitter release and subsequent pyramidal neuron activation to mediate neurological responses associated with stress and depression. Similar antagonism of M4 and M5 receptors is associated with potential therapeutic benefits in neurological conditions such as schizophrenia and substance abuse disorders. The significance of these observations to scopolamine's current therapeutic indications of preventing nausea and vomiting is unclear but is linked to its anticholinergic effect and ability to alter signalling through the CNS associated with vomiting.


Although other antimuscarinics have been used in the prevention of motion sickness, it appears that scopolamine is most effective. Scopolamine apparently corrects some central imbalance of acetylcholine and norepinephrine that may occur in patients with motion sickness. It has been suggested that antimuscarinics may block the transmission of cholinergic impulses from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center; these effects result in prevention of motion-induced nausea and vomiting.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 1323


The sole active agent of Transderm Scoop is scopolamine, a belladonna alkaloid with well known pharmacological properties. It is an anticholinergic agent which acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center.

Thomson Health Care Inc.; Physicians' Desk Reference 62 ed., Montvale, NJ 2008, p. 2192


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C-24,INDUSTRIAL HYDERABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"SCOPOLAMINE EP (SCOPOLAMINE BASE EP)","address":"NO 44, JALAVAYU VIHAR,KUKATPALLY","city":"HYDERABAD,TELANGANA","supplier":"PHYTEX AUSTRALIA PTY LTD","supplierCountry":"AUSTRALIA","foreign_port":"NA","customer":"SPARSHA PHARMA INTERNATIONAL PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"28000","totalValueFC":"14120.1","currency":"USD","unitRateINR":"2247000","date":"05-Aug-2022","totalValueINR":"1123500","totalValueInUsd":"14120.1","indian_port":"HYDERABAD AIR","hs_no":"29397900","bill_no":"9884278","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 44, JALAVAYU VIHAR,KUKATPALLY"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662834600,"product":"HYOSCINE HYDROBROMIDE EP BATCH NO.255203105001 DOM: 07.05.2020 DOE: 06.05.2025(RE-IMPORT FOR RE PROCESSING AND RE EXPORT","address":"201, EMPIRE PLAZA, MEHRAULI GURGAON ROAD, SULTANPUR, Contact No","city":"NEW DELHI","supplier":"ALCHEM INTERNATIONAL (HK) LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"ALCHEM INTERNATIONAL PVT LTD","customerCountry":"INDIA","quantity":"0.14","actualQuantity":"0.136","unit":"KGS","unitRateFc":"2200","totalValueFC":"300.4","currency":"USD","unitRateINR":"176990","date":"11-Sep-2022","totalValueINR":"24070.64","totalValueInUsd":"300.4","indian_port":"DELHI AIR","hs_no":"29397900","bill_no":"2390409","productDescription":"Re-export","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, EMPIRE PLAZA, MEHRAULI GURGAON ROAD, SULTANPUR, Contact No"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1667586600,"product":"SCOPOLAMINE BASE ( HYOSCINE ) BN : 0521100 PACKAGED AS 1 X 1 KG & 14 X 25G. ( EP SPECIFICATION )","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"PHYTEX AUSTRALIA PTY LTD","supplierCountry":"AUSTRALIA","foreign_port":"SYDNEY","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"37800","totalValueFC":"38813.1","currency":"USD","unitRateINR":"3167640","date":"05-Nov-2022","totalValueINR":"3167640","totalValueInUsd":"38813.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29398000","bill_no":"1004584","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SYDNEY","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676831400,"product":"CHEMICAL : BUTYLSCOPOLAMINE MICRONIZED","address":"TORRENT HOUSE, OFF ASHRAM ROAD,","city":"AHMEDABAD","supplier":"LINNEA SA","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TORRENT PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1480","totalValueFC":"7495","currency":"USD","unitRateINR":"123802","date":"20-Feb-2023","totalValueINR":"619010","totalValueInUsd":"7495","indian_port":"AHMEDABAD AIR","hs_no":"29397900","bill_no":"4713489","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"TORRENT HOUSE, OFF ASHRAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677868200,"product":"BUTYLSCOPOLAMINE MICRONIZED","address":"TORRENT HOUSE, OFF ASHRAM ROAD,","city":"AHMEDABAD","supplier":"LINNEA SA","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TORRENT PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"1480","totalValueFC":"52587","currency":"USD","unitRateINR":"123580","date":"04-Mar-2023","totalValueINR":"4325300","totalValueInUsd":"52587","indian_port":"BOMBAY AIR","hs_no":"29397900","bill_no":"4905291","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"TORRENT HOUSE, OFF ASHRAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682447400,"product":"NORSCOPOLAMINE(QTY:1 X 20MG,VALUE:USD 838)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"41900000","totalValueFC":"896.5","currency":"USD","unitRateINR":"3673629500","date":"26-Apr-2023","totalValueINR":"73472.59","totalValueInUsd":"896.5","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"5681755","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684348200,"product":"HYOSCINE BUTYL BROMIDE BP RE IMPORT S B NO8755112 DT 25 03 2023 INV NO345 2022 23 DT 22 03 2023 BATCH NO HBBR 0","address":"214A, TRIVIA COMPLEX, NR. NATUBHAI ,CIRCLE, RACE COURSE,","city":"VADODARA","supplier":"MEDBRIDGE PHARMACEUTICAL LIMITED","supplierCountry":"HONG KONG","foreign_port":"XIAMEN","customer":"PRISM INDUSTRIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"7.50","actualQuantity":"7.5","unit":"KGS","unitRateFc":"1150","totalValueFC":"9186.9","currency":"USD","unitRateINR":"100792","date":"18-May-2023","totalValueINR":"755939.78","totalValueInUsd":"9186.9","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"","country":"Hong Kong","selfForZScoreResived":"Pharma Grade","supplierPort":"XIAMEN","supplierAddress":"","customerAddress":"214A, TRIVIA COMPLEX, NR. NATUBHAI ,CIRCLE, RACE COURSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687458600,"product":"HYOSCINE BUTYLBROMIDE EP-10\/BP-2022 BATCH NO:HBB2207006 (RE-IMPORT-REJECT & RETURN FOR RE-PROCESS& RETURN)SB NO:3997319","address":"20 C HAZRA ROAD","city":"KOLKATA","supplier":"LABORATORIO INTERNATIONAL DE COLOMBIA (LIDCSA","supplierCountry":"INDIA","foreign_port":"NA","customer":"ANZEN EXPORTS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1135","totalValueFC":"117343.1","currency":"USD","unitRateINR":"96451.4","date":"23-Jun-2023","totalValueINR":"9645167.056","totalValueInUsd":"117343.1","indian_port":"BOMBAY AIR","hs_no":"29391900","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"20 C HAZRA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692556200,"product":"HYOSCINE BUTYL BROMIDE IP","address":"3RD & 4TH FLOORS, H.NO. 5-10-173,F ATEH MAIDAN ROAD, BASHEERBAGH","city":"HYDERABAD","supplier":"SANOFI-AVENTIS SINGAPORE PTE LIMITED","supplierCountry":"ITALY","foreign_port":"NA","customer":"SANOFI HEALTHCARE INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"346.50","actualQuantity":"346.5","unit":"KGS","unitRateFc":"722","totalValueFC":"277339.6","currency":"EURO","unitRateINR":"65639.4","date":"21-Aug-2023","totalValueINR":"22973794.17","totalValueInUsd":"277339.6","indian_port":"SAHAR AIR","hs_no":"29397900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"3RD & 4TH FLOORS, H.NO. 5-10-173,F ATEH MAIDAN ROAD, BASHEERBAGH"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700764200,"product":"SCOPOLAMINE (HYOSCINE) PH EUR (QTY: 100GMS, VALUE : USD 3000)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"FINE CHEMICALS CORPORATION (PTY) LTD","supplierCountry":"SOUTH AFRICA","foreign_port":"CAPE TOWN","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"30000","totalValueFC":"3029.9","currency":"USD","unitRateINR":"2523000","date":"24-Nov-2023","totalValueINR":"252300","totalValueInUsd":"3029.9","indian_port":"Hyderabad Air","hs_no":"29398000","bill_no":"8911369","productDescription":"API","marketType":"","country":"SOUTH AFRICA","selfForZScoreResived":"Pharma Grade","supplierPort":"CAPE TOWN","supplierAddress":"15 HAWKINS AVENUE, EPPING 1, 7460,CAPE TOWN PO BOX 253, EPPINDUST, 7475 SOUTH AFRICA South Africa","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700850600,"product":"HYOSCINE BUTYLBROMIDE EP BATCH NO.255103305010 DOM:15.05.2022-DOE: 14.05.2027(RE-IMPORT FOR RE PROCESSING AND RE EXPORT)","address":"301, AVALON APARTMENTS,MEHRAULI","city":"NEW DELHI","supplier":"ALCHEM INTERNATIONAL (HK) LTD","supplierCountry":"INDIA","foreign_port":"TOKYO - NARITA","customer":"ALCHEM INTERNATIONAL PVT LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1750","totalValueFC":"176764.1","currency":"USD","unitRateINR":"147193","date":"25-Nov-2023","totalValueINR":"14719300","totalValueInUsd":"176764.1","indian_port":"Delhi Air","hs_no":"29397900","bill_no":"8942034","productDescription":"Re-export","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"ROOM 1706, THE L. PLAZA 367-375 QUEEN\\'S ROAD CENTRAL HONG KONG , , HONG KONG HONG KONG","customerAddress":"301, AVALON APARTMENTS,MEHRAULI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701455400,"product":"(THIRD COUNTRY EXPORT) SCOPOLAMINE BUTYLBROMIDE (HYOSCINE BUTYLBROMIDE) EX BOEHRINGER INGELHEIM","address":"Office no. 210, Rajasthan Technical Centre Premises CSL, Patanwala Compound","city":"MUMBAI","supplier":"THODE + SCOBEL GMBH & COKG","supplierCountry":"GERMANY","foreign_port":"HAMBURG - FUHLSBUETT","customer":"HOPEWELL SOLUTIONS","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"1120","totalValueFC":"45770.3","currency":"USD","unitRateINR":"95251.7","date":"02-Dec-2023","totalValueINR":"3810066.4","totalValueInUsd":"45770.3","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"9032993","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"P.O BOX 70 23 43 D-22023 HAMBURGSDNFSDNF Germany","customerAddress":"Office no. 210, Rajasthan Technical Centre Premises CSL, Patanwala Compound"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702233000,"product":"HYOSCINE BUTYL BROMIDE IP","address":"3RD 4TH FLOORS, H.NO. 5-10-173","city":"HYDERABAD, AP","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"ITALY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SANOFI HEALTHCARE INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"349.90","actualQuantity":"349.9","unit":"KGS","unitRateFc":"722","totalValueFC":"277230.6","currency":"EURO","unitRateINR":"65954.7","date":"11-Dec-2023","totalValueINR":"23077549.53","totalValueInUsd":"277230.6","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"9168603","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH TOWER SINGAPORE 189767 Singapore, ,Singapore Singapore","customerAddress":"3RD 4TH FLOORS, H.NO. 5-10-173"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703097000,"product":"BUTYLSCOPOLAMINE (HYOSCINE BUTYLBROMIDE) (TEST LIC NO - 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24-Apr-2025
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ABOUT THIS PAGE

Looking for 51-34-3 / Scopolamine API manufacturers, exporters & distributors?

Scopolamine manufacturers, exporters & distributors 1

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

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

PharmaCompass also assists you with knowing the Scopolamine API Price utilized in the formulation of products. Scopolamine API Price is not always fixed or binding as the Scopolamine Price is obtained through a variety of data sources. The Scopolamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Scopolamine

Synonyms

Hyoscine, (-)-hyoscine, 51-34-3, Scopine (-)-tropate, Scopine tropate, (-)-scopolamine

Cas Number

51-34-3

Unique Ingredient Identifier (UNII)

DL48G20X8X

About Scopolamine

An alkaloid from SOLANACEAE, especially DATURA and SCOPOLIA. Scopolamine and its quaternary derivatives act as antimuscarinics like ATROPINE, but may have more central nervous system effects. Its many uses include an anesthetic premedication, the treatment of URINARY INCONTINENCE and MOTION SICKNESS, an antispasmodic, and a mydriatic and cycloplegic.

Travacalm HO Manufacturers

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

Travacalm HO Suppliers

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

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

Travacalm HO USDMF

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

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

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

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

Travacalm HO KDMF

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

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

After submitting a Travacalm HO 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 Travacalm HO API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Travacalm HO suppliers with KDMF on PharmaCompass.

Travacalm HO CEP

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

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

Travacalm HO WC

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

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

Travacalm HO 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 Travacalm HO as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Travacalm HO GMP

Travacalm HO 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 Travacalm HO 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 Travacalm HO GMP manufacturer or Travacalm HO GMP API supplier for your needs.

Travacalm HO CoA

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

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

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