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    Chemistry

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    Also known as: Phylloquinone, Phytonadione, 84-80-0, Phytomenadione, Phytylmenadione, 3-phytylmenadione
    Molecular Formula
    C31H46O2
    Molecular Weight
    450.7  g/mol
    InChI Key
    MBWXNTAXLNYFJB-NKFFZRIASA-N
    FDA UNII
    MLF3D1712D
    Vitamin K1
    A family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic bacteria. Vitamin K1 has antihemorrhagic and prothrombogenic activity.
    1 2D Structure

    Vitamin K1

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-methyl-3-[(E,7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4-dione
    2.1.2 InChI
    InChI=1S/C31H46O2/c1-22(2)12-9-13-23(3)14-10-15-24(4)16-11-17-25(5)20-21-27-26(6)30(32)28-18-7-8-19-29(28)31(27)33/h7-8,18-20,22-24H,9-17,21H2,1-6H3/b25-20+/t23-,24-/m1/s1
    2.1.3 InChI Key
    MBWXNTAXLNYFJB-NKFFZRIASA-N
    2.1.4 Canonical SMILES
    CC1=C(C(=O)C2=CC=CC=C2C1=O)CC=C(C)CCCC(C)CCCC(C)CCCC(C)C
    2.1.5 Isomeric SMILES
    CC1=C(C(=O)C2=CC=CC=C2C1=O)C/C=C(\C)/CCC[C@H](C)CCC[C@H](C)CCCC(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    MLF3D1712D
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Aquamephyton

    2. Konakion

    3. Phyllohydroquinone

    4. Phylloquinone

    5. Phytomenadione

    6. Phytonadione

    7. Vitamin K 1

    2.3.2 Depositor-Supplied Synonyms

    1. Phylloquinone

    2. Phytonadione

    3. 84-80-0

    4. Phytomenadione

    5. Phytylmenadione

    6. 3-phytylmenadione

    7. Aquamephyton

    8. Konakion

    9. Mephyton

    10. Monodion

    11. Phyllochinon

    12. Synthex P

    13. 2-methyl-3-phytyl-1,4-naphthoquinone

    14. Kinadion

    15. Vitamink1

    16. Mono-kay

    17. Combinal K1

    18. Kativ N

    19. Alpha-phylloquinone

    20. Trans-phylloquinone

    21. K-ject

    22. Fitomenadiona

    23. Phyllochinonum

    24. Phytomenadionum

    25. Phytonadionum

    26. Aqua Mephyton

    27. Antihemorrhagic Vitamin

    28. Vitamin K 1

    29. Fitomenadione

    30. Aqua-mephytin

    31. Kephton

    32. 79083-00-4

    33. 2',3'-trans-vitamin K1

    34. 2-methyl-3-phytyl-1,4-naphthochinon

    35. 11104-38-4

    36. Vitamin K

    37. Phylloquinone E-form

    38. 2-methyl-3-[(2e,7r,11r)-3,7,11,15-tetramethylhexadec-2-en-1-yl]naphthalene-1,4-dione

    39. Chebi:18067

    40. 2-methyl-3-[(e,7r,11r)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4-dione

    41. Nsc 270681

    42. Nsc-270681

    43. S5z3u87qhf

    44. 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione

    45. 1,4-naphthoquinone, 2-methyl-3-phytyl-

    46. Phythyl-menadion

    47. Mlf3d1712d

    48. Phytonadione, (e)-(+/-)-

    49. 1,4-naphthalenedione,2-methyl-3-[(2e,7r,11r)-3,7,11,15-tetramethyl-2-hexadecen-1-yl]-

    50. Dsstox_cid_3472

    51. 1,4-naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-, (r-(r*,r*-(e)))-

    52. 2-methyl-3-((7r,11r,e)-3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione

    53. Dsstox_rid_77041

    54. Dsstox_gsid_23472

    55. Vitamin K1-18o(mixture Of 1-18o And 4-18o)

    56. Orakay

    57. 1,4-naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-

    58. 2-methyl-3-[(2e)-3,7,11,15-tetramethyl-2-hexadecenyl]naphthoquinone

    59. 2-methyl-3-phythyl-1,4-naphthochinon

    60. Cas-84-80-0

    61. Rel-2-methyl-3-((7r,11r,e)-3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione

    62. Phytonadione, K1

    63. 1,4-naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-, [r-[r*,r*-(e)]]-

    64. Phyllochinon [german]

    65. Fitomenadione [dcit]

    66. Vitamin K1 (van)

    67. Phytonadione [usp:jan]

    68. Unii-s5z3u87qhf

    69. Fitomenadiona [inn-spanish]

    70. Phytomenadionum [inn-latin]

    71. Kanavit

    72. Neokay

    73. A-phylloquinone

    74. Konakion Mm

    75. Konakion Mm Paed

    76. Hsdb 3162

    77. Vitamin K1 Oil

    78. (e)-phytonadione

    79. 2-methyl-3-((7r,11r,e)-3,7,11,15-tetramethylhexadec-2-enyl)naphthalene-1,4-dione

    80. Ncgc00159423-02

    81. Trans-phytomenadione

    82. Einecs 201-564-2

    83. Einecs 234-330-3

    84. Einecs 279-052-3

    85. Mfcd00214063

    86. Vitamin K1, 11

    87. Vitamin K1 (generic)

    88. Vitamin K1 ,(s)

    89. Phytonadione [jan]

    90. 2-methyl-3-phytyl-1,4-naphthochinon [german]

    91. Schembl3882

    92. Vitamin K1 (phylloquinone)

    93. Vitamin K1, Viscous Liquid

    94. Chembl1550

    95. Unii-mlf3d1712d

    96. Phytonadione, (e)-

    97. Phylloquinone, (e)-

    98. Mls001074732

    99. Bidd:gt0793

    100. Phytomenadione, (e)-

    101. Schembl351365

    102. Vitamin K1 (e-phytonadione)

    103. 2-methyl-3-[(2e)-3,7,11,15-tetramethyl-2-hexadecenyl]naphthoquinone #

    104. Dtxsid8023472

    105. Bdbm24782

    106. [r-[r*,r*-(e)]]-2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-napthalenedione

    107. [r-[r*,r*-(e)]]-2-methyl-3-(3-7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione

    108. Phylloquinone E-form [mi]

    109. Hms2094g09

    110. Hms2270j10

    111. Pharmakon1600-01505485

    112. 10485-69-5

    113. Hy-n0684

    114. Zinc3831332

    115. Tox21_111655

    116. Bdbm50553259

    117. Lmpr02030028

    118. Nsc760373

    119. S4698

    120. 2-methyl-3-phytyl-1,4-napthoquinone

    121. Akos015841892

    122. Tox21_111655_1

    123. Ccg-213568

    124. Cs-6376

    125. Db01022

    126. Nsc-760373

    127. (r*,r*-(e))-(1)-2-methyl-3-(3,7,11,15-tetramethylhexadec-2-enyl)-1,4-naphthoquinone

    128. Ncgc00159423-03

    129. Phylloquinone (k1), Analytical Standard

    130. Ac-34846

    131. As-13734

    132. Smr000112043

    133. Sbi-0206926.p001

    134. Trans-phytomenadione 100 Microg/ml In Ethanol

    135. Ab00698065_04

    136. 214v063

    137. A840928

    138. Q186093

    139. Sr-05000001941

    140. C31h46o2 (2-methyl-3-phytyl-1,4-naphthoquinone)

    141. Q-201934

    142. Sr-05000001941-1

    143. W-108488

    144. 2-methyl-3-((7r,11r,e)-3,7,11,15-tetramethylhexadec

    145. 84c51b31-3ce2-476b-be66-a84bdd46a513

    146. Vitamin K1; 2-methyl-3-phytyl-1,4-naphthoquinone

    147. Phytomenadione, European Pharmacopoeia (ep) Reference Standard

    148. Phytonadione, United States Pharmacopeia (usp) Reference Standard

    149. 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalened- Ione

    150. Vitamin K1 Solution, 10 Mug/ml In Ethanol, Certified Reference Material

    151. Vitamin K1, Bioxtra, >=99.0% (sum Of Isomers, Hplc), Mixtur Of Isomers

    152. 1,4-naphthalenedione, 2-methyl-3-((2e,7r,11r)-3,7,11,15-tetramethyl-2-hexadecen-1-yl)-

    153. 1,4-naphthalenedione, 2-methyl-3-((2e,7r,11r)-3,7,11,15-tetramethyl-2-hexadecenyl)-

    154. Phytonadione, Pharmaceutical Secondary Standard; Certified Reference Material

    155. 1,4-naphthalenedione, 2-methyl-3-((2e,7r,11r)-3,7,11,15-tetramethyl-2-hexadecen-1-yl)-, Rel-

    156. 2-methyl-3-((2e,7r,11r)-3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione

    157. 2-methyl-3-[(2e,7r,11r)-3,7,11,15-tetramethylhexadec-2-en-1-yl]-1,4-dihydronaphthalene-1,4-dione

    158. 2-methyl-3-[(e,7r,11r)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4-dione;vitamin K1

    159. Vitamin K1-13c6 Solution, 5 Mug/ml In Ethanol, Certified Reference Material, Ampule Of 1 Ml

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 450.7 g/mol
    Molecular Formula C31H46O2
    XLogP310.9
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count14
    Exact Mass450.349780706 g/mol
    Monoisotopic Mass450.349780706 g/mol
    Topological Polar Surface Area34.1 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity696
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NamePhytonadione
    Drug LabelPhytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3...
    Active IngredientPhytonadione
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.5ml
    Market StatusPrescription
    CompanyIntl Medication

    2 of 4  
    Drug NameVitamin k1
    PubMed HealthPhytonadione
    Drug ClassesNutriceutical, Nutritive Agent
    Drug LabelPhytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3...
    Active IngredientPhytonadione
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.5ml; 10mg/ml
    Market StatusPrescription
    CompanyHospira

    3 of 4  
    Drug NamePhytonadione
    Drug LabelPhytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3...
    Active IngredientPhytonadione
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.5ml
    Market StatusPrescription
    CompanyIntl Medication

    4 of 4  
    Drug NameVitamin k1
    PubMed HealthPhytonadione
    Drug ClassesNutriceutical, Nutritive Agent
    Drug LabelPhytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3...
    Active IngredientPhytonadione
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.5ml; 10mg/ml
    Market StatusPrescription
    CompanyHospira

    4.2 Therapeutic Uses

    Antifibrinolytic Agents

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

    THE RATIONAL THERAPEUTIC USE OF VITAMIN K IS BASED ON ITS ABILITY TO CORRECT BLEEDING TENDENCY OR HEMORRHAGE ASSOC WITH ITS DEFICIENCY. A DEFICIENCY OF VITAMIN K & ITS ATTENDANT DEFICIENCY OF PROTHROMBIN & RELATED CLOTTING FACTORS CAN RESULT FROM INADEQUATE INTAKE, ABSORPTION, OR UTILIZATION OF VITAMIN, OR AS A CONSEQUENCE OF ACTION OF THE ACTION OF A VITAMIN K ANTAGONIST. /VITAMIN K/

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1785

    BLEEDING THAT ACCOMPANIES OBSTRUCTIVE JAUNDICE OR BILIARY FISTULA RESPONDS PROMPTLY TO ADMINISTRATION OF VITAMIN K. ORAL PHYTONADIONE ADMIN WITH BILE SALTS IS BOTH SAFE AND EFFECTIVE AND SHOULD BE USED IN THE CARE OF THE JAUNDICED PATIENT, BOTH PREOPERATIVELY & POSTOPERATIVELY.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1785

    IF FOR SOME REASON ORAL ADMIN IS NOT FEASIBLE /IN TREATMENT OF OBSTRUCTIVE JAUNDICE OR BILIARY FISTULA/, A PARENTERAL PREPN SHOULD BE USED.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1785

    For more Therapeutic Uses (Complete) data for PHYTONADIONE (22 total), please visit the HSDB record page.

    4.3 Drug Warning

    IN PT WHO HAVE SEVERE HEPATIC DISEASE, ADMIN OF LARGE DOSES OF MENADIONE OR PHYLLOQUINONE MAY FURTHER DEPRESS FUNCTION OF LIVER.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1784

    Maternal Medication usually Compatible with Breast-Feeding: K1 (vitamin): Reported Sign or Symptom in Infant or Effect on Lactation: None. /from Table 6/

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

    A rare hypersensitivity-like reaction, which has occasionally resulted in death, has been reported after intravenous administration of phytonadione, especially when administration is rapid.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2957

    In newborns, especially premature infants, mendiol sodium diphosphate has been associated with hemolytic anemia, hyperbilirubinemia, and kernicterus because of immature hepatic function in these infants. There is less risk with phytonadione, unless high doses are given.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2957

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

    4.4 Drug Indication

    Oral phylloquinone is indicated to treat prothrombin deficiency caused by coumarin or indanedione derivatives; and hypoprothrombinemia secondary to antibacterial therapy, salicylates, or obstructive jaundice or biliary fistulas with concomitant bile salt administration. Parenteral (intravenous, intramuscular, and subcutaneous) phylloquinone is indicated to treat coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by vitamin K deficiency or some interference with vitamin K activity. These indications include the above indications as well as hypoprothrombinemia secondary to sprue, ulcerative colitis, celiac disease, intestinal resection, pancreatic cystic fibrosis, or regional enteritis; or hypoprothrombinemia caused by interference with vitamin k metabolism.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Phylloquinone is a vitamin K indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K. It has a long duration of action as vitamin K is cycled in the body, and a wide therapeutic index as large doses can be tolerated. Patients should have their prothrombin time monitored during therapy and healthcare professionals should be aware of the increased risk of hypersensitivity reactions with parenteral administration.

    5.2 MeSH Pharmacological Classification

    Antifibrinolytic Agents

    Agents that prevent fibrinolysis or lysis of a blood clot or thrombus. Several endogenous antiplasmins are known. The drugs are used to control massive hemorrhage and in other coagulation disorders. (See all compounds classified as Antifibrinolytic Agents.)

    Vitamins

    Organic substances that are required in small amounts for maintenance and growth, but which cannot be manufactured by the human body. (See all compounds classified as Vitamins.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Reversed Anticoagulation Activity [PE]; Vitamin K [CS]; Vitamin K [EPC]; Warfarin Reversal Agent [EPC]; Increased Prothrombin Activity [PE]
    5.4 ATC Code

    B02BA01

    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

    B - Blood and blood forming organs

    B02 - Antihemorrhagics

    B02B - Vitamin k and other hemostatics

    B02BA - Vitamin k

    B02BA01 - Phytomenadione

    5.5 Absorption, Distribution and Excretion

    Absorption

    A 4 g oral dose of phylloquinone is 13% 9% bioavailable, with a Tmax of 4.7 0.8 hours. 1.5 0.8 nmol is found in the plasma compartment, and 3.6 3.4 nmol is found in the second compartment. A 10 mg intramuscular phylloquinone dose is 89.2% 25.4% bioavailable. The same dose reaches a mean Cmax of 67 30 ng/mL, with a mean Tmax of 9.2 6.6 hours, and an AUC of 1700 500 h\*ng/mL. A 10 mg intravenous phylloquinone dose has a mean AUC of 1950 450 h\*ng/mL.

    Route of Elimination

    Intravenous phylloquinone is 36% eliminated in the feces in 5 days and 22% recovered in urine in 3 days.

    Volume of Distribution

    The steady state volume of distribution of phylloquinone is 20 6 L in subjects who are also taking phenprocoumon therapy.

    Clearance

    Intravenous phylloquinone is 90% cleared in 2 hours, and 99% cleared in 8 hours. A 10 mg intravenous dose of phylloquinone has a mean clearance of 91 24 mL/min.

    Little is known about the excretion of vitamin K. High fecal concentrations of vitamin K probably result from bacterial synthesis in the intestine.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 3566

    Although the drug may be concentrated in the liver for a short time after absorption, only small amounts of phytonadione are stored in body tissues.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 3566

    Phytonadione is absorbed from the GI tract only in the presence of bile salts. Radioisotope studies show that absorption occurs via intestinal lymph. There is some evidence that absorption of phytonadione across the GI mucosa is a saturable, energy-dependent process that occurs in the proximal small intestine.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 3566

    Fat-soluble vit...k...absorbed from skin... /vit k/

    Hayes, W.J., Jr., E.R. Laws Jr., (eds.). Handbook of Pesticide Toxicology Volume 1. General Principles. New York, NY: Academic Press, Inc., 1991., p. 139

    For more Absorption, Distribution and Excretion (Complete) data for PHYTONADIONE (7 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Phylloquinone's phytyl side chain is omega hydroxylated by CYP4F2. The side chain is then cleaved to 5 or 7 carbons long, and then glucuronidated prior to elimination. Vitamin Ks in general undergo a cycle of reduction to vitamin K hydroquinone by vitamin K epoxide reductase (VKOR), oxidation to vitamin K epoxide by gamma-glutamyl carboxylase, and converted back to vitamin K by VKOR.

    ...In experimental animals...phylloquinone...can be converted to more potent menaquinone series. Whether this can occur in man and of what significance these transformations are to action of phylloquinone...are still unknown.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1593

    In animals treated with warfarin, major fraction of phylloquinone is metabolized to phylloquinone oxide.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1593

    Phytonadione is rapidly metabolized to more polar metabolites, which are excreted in the bile and urine. The major urinary metabolites result from shortening of the side chain to five or seven carbon atoms, yielding carboxylic acids that are conjugated with glucuronate prior to excretion. Treatment with a coumarin-type anticoagulant results in a marked increase in the amount of phytonadione-2,3-epoxide in the liver and blood. Such treatment also increases the urinary excretion of phytonadione metabolites, primarily degradative products of phytonadione-2,3-epoxide. The biliary metabolites of phytonadione have not been identified.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1784

    The liver plays an exclusive role in the metabolic transformations leading to the elimination of vitamin K from the body. After intravenous doses of 45 ug to 1 mg (3)H-phylloquinone, about 20% of the radiolabel was excreted in the urine within three days, and 35-50% was excreted as metabolites in the feces via the bile.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V76 461-2 (2000)

    5.7 Biological Half-Life

    Intravenous phylloquinone has an initial half life of 22 minutes, followed by a half life of 125 minutes.

    5.8 Mechanism of Action

    Vitamin K is a cofactor of gamma-carboxylase. Gamma carboxylase attaches carboxylic acid functional groups to glutamate, allowing precursors of factors II, VII, IX, and X to bind calcium ions. Binding of calcium ions converts these clotting factors to their active form, which are then secreted from hepatocytes into the blood, restoring normal clotting function. Vitamin K may also carboxylate matrix proteins in chondrocytes, inhibiting calcification of joints, and may increase type II collagen. The role of vitamin K in osteroarthritis, bone density, and vascular calcification is currently under investigation.

    Vit k is necessary for formation of prothrombinogen & other blood clotting factors in liver. During clotting, circulating prothrombin is required for production of thrombin; in turn, thrombin converts fibrinogen to fibrin, network of which constitutes clot. /vit k/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 943

    In normal animals and man, phyltonadione ... /is/ virtually devoid of pharmacodynamic activity. In Animals and man deficient in vitamin k, the pharmacological action of vitamin k is identical to its normal physiological function, that is, to promote hepatic biosynthesis of prothrombin (factor ii), proconvertin (factor vii), plasma thromboplastin component (ptc, christmas factor, factor ix), and Stuart factor (factor x).

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1783

    On the basis of studies of microsomal metabolism in vitro and studies in rats and mice in vivo, /it was suggested/ that vitamin K may be mutagenic by affecting the mixed-function oxidase system which metabolizes benzo(a)pyrene. Phylloquinone at a high concentration (200 umol/l) inhibited the conversion of benzo(a)pyrene to its more polar metabolites, ... . Paradoxically, at a lower concentration of phylloquinone (25 umol/l), ... the metabolism of benzo(a)pyrene was increased. In this system, therefore, .... phylloquinone could either potentiate or inhibit it, depending on the concentration. This overall weaker inhibitory effect of phylloquinone could be due to the low solubility of this lipophilic compound, but it is difficult to explain the mechanism of the enhanced metabolism of benzo(a)pyrene at lower concentrations of phylloquinone.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V76 472 (2000)

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    25-Jan-2022
    29-Jul-2025
    KGS
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    Drugs in Development

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    A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With...

    Details:

    Risankizumab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Colitis, Ulcerative.


    Lead Product(s): Risankizumab,Midazolam,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Metoprolol Tartrate

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Antibody, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 05, 2020

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Risankizumab,Midazolam,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Metoprolol Tartrate

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics o...

    Details : Risankizumab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Colitis, Ulcerative.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    February 05, 2020

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    Alembic Gets FDA Final Approval for Phytonadione Injectable Emulsion

    Details:

    Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference.


    Lead Product(s): Vitamin K1,Inapplicable

    Therapeutic Area: Hematology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 10, 2025

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    Alembic Pharmaceuticals Limited

    India
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    Alembic Pharmaceuticals Limited

    India
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    Lead Product(s) : Vitamin K1,Inapplicable

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Gets FDA Final Approval for Phytonadione Injectable Emulsion

    Details : Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 10, 2025

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    Phase I Open-Label DDI Study of Radiprodil with Co-Administered Drugs

    Details:

    Radiprodil is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Tuberous Sclerosis.


    Lead Product(s): Radiprodil,Warfarin Sodium,Midazolam,Digoxin,Rosuvastatin Calcium,Omeprazole,Vitamin K1

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Avance Clinical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 16, 2025

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    03

    GRIN Therapeutics

    U.S.A
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    GRIN Therapeutics

    U.S.A
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    Lead Product(s) : Radiprodil,Warfarin Sodium,Midazolam,Digoxin,Rosuvastatin Calcium,Omeprazole,Vitamin K1

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Avance Clinical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Phase I Open-Label DDI Study of Radiprodil with Co-Administered Drugs

    Details : Radiprodil is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Tuberous Sclerosis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 16, 2025

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    Caplin Steriles gets USFDA Approval for Phytonadione Injectable Emulsion

    Details:

    Vitamin K1, also called phytonadione, is a cofactor of the enzyme γ-carboxylase, which activates precursors to coagulation factors II, VII, IX, and X, in patients with blood clotting disorders.


    Lead Product(s): Vitamin K1,Inapplicable

    Therapeutic Area: Hematology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 24, 2025

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    04

    Caplin Steriles

    India
    arrow
    The MedTech Conference
    Not Confirmed

    Caplin Steriles

    India
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Vitamin K1,Inapplicable

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Caplin Steriles gets USFDA Approval for Phytonadione Injectable Emulsion

    Details : Vitamin K1, also called phytonadione, is a cofactor of the enzyme γ-carboxylase, which activates precursors to coagulation factors II, VII, IX, and X, in patients with blood clotting disorders.

    Product Name : Undisclosed

    Product Type : Vitamins/Minerals/Inorganic Salts

    Upfront Cash : Inapplicable

    April 24, 2025

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    Glenmark Pharma Edges Higher after US Launch of Coagulation Disorder Drug Phytonadione

    Details:

    Phytonadione is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.


    Lead Product(s): Vitamin K1,Inapplicable

    Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 22, 2025

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    05

    Glenmark Pharmaceuticals

    India
    arrow
    The MedTech Conference
    Not Confirmed

    Glenmark Pharmaceuticals

    India
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    The MedTech Conference
    Not Confirmed
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    Lead Product(s) : Vitamin K1,Inapplicable

    Therapeutic Area : Nutrition and Weight Loss

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Glenmark Pharma Edges Higher after US Launch of Coagulation Disorder Drug Phytonadione

    Details : Phytonadione is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

    Product Name : Undisclosed

    Product Type : Vitamins/Minerals/Inorganic Salts

    Upfront Cash : Inapplicable

    January 22, 2025

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    Gland Pharma Receives USFDA Approval for Phytonadione Injectable Emulsion

    Details:

    Phytonadione is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.


    Lead Product(s): Vitamin K1,Inapplicable

    Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 11, 2024

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    06

    GLAND PHARMA LIMITED

    India
    arrow
    The MedTech Conference
    Not Confirmed

    GLAND PHARMA LIMITED

    India
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Vitamin K1,Inapplicable

    Therapeutic Area : Nutrition and Weight Loss

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Gland Pharma Receives USFDA Approval for Phytonadione Injectable Emulsion

    Details : Phytonadione is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

    Product Name : Undisclosed

    Product Type : Vitamins/Minerals/Inorganic Salts

    Upfront Cash : Inapplicable

    December 11, 2024

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    BPGbio Announces First Patients Dosed in Phase 2 Trial of AI-Developed BPM 31510 for Glioblastoma Multiforme

    Details:

    BPM 31510, the company’s lead drug candidate, acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death.


    Lead Product(s): Ubidecarenone,Temozolomide,Vitamin K1

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Vitamins/Minerals/Inorganic Salts

    Sponsor: Berg Health

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 06, 2023

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    07

    BPGbio

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed

    BPGbio

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Ubidecarenone,Temozolomide,Vitamin K1

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Berg Health

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    BPGbio Announces First Patients Dosed in Phase 2 Trial of AI-Developed BPM 31510 for Glioblastoma ...

    Details : BPM 31510, the company’s lead drug candidate, acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death.

    Product Name : Undisclosed

    Product Type : Vitamins/Minerals/Inorganic Salts

    Upfront Cash : Inapplicable

    June 06, 2023

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    A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

    Details:

    SHR0302 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Rheumatoid.


    Lead Product(s): Ivarmacitinib,Midazolam Maleate,Warfarin Sodium,Omeprazole,Vitamin K1,Repaglinide

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 26, 2022

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    08

    Jiangsu Hengrui Medicine

    China
    arrow
    The MedTech Conference
    Not Confirmed

    Jiangsu Hengrui Medicine

    China
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Ivarmacitinib,Midazolam Maleate,Warfarin Sodium,Omeprazole,Vitamin K1,Repaglinide

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Hea...

    Details : SHR0302 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Rheumatoid.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 26, 2022

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    A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

    Details:

    HRS5091 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B, Chronic.


    Lead Product(s): HRS5091,Midazolam Maleate,Warfarin Sodium,Omeprazole,Vitamin K1,Digoxin,Rosuvastatin Calcium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Undisclosed

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 10, 2022

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    09

    Jiangsu Hengrui Medicine

    China
    arrow
    The MedTech Conference
    Not Confirmed

    Jiangsu Hengrui Medicine

    China
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : HRS5091,Midazolam Maleate,Warfarin Sodium,Omeprazole,Vitamin K1,Digoxin,Rosuvastatin Calcium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Health...

    Details : HRS5091 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B, Chronic.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Inapplicable

    March 10, 2022

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    Better Evidence and Translation for Calciphylaxis

    Details:

    Vitamin K1 is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Calciphylaxis.


    Lead Product(s): Vitamin K1,Sodium Chloride,Magnesium Citrate,Sodium Thiosulfate

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts

    Sponsor: Australasian Kidney Trials Network | Northern Care Alliance NHS Foundation Trust | Waitemata District Health Board

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 24, 2021

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    10

    University of Sydney

    Country
    arrow
    The MedTech Conference
    Not Confirmed

    University of Sydney

    Country
    arrow
    The MedTech Conference
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Vitamin K1,Sodium Chloride,Magnesium Citrate,Sodium Thiosulfate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Australasian Kidney Trials Network | Northern Care Alliance NHS Foundation Trust | Waitemata District Health Board

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Better Evidence and Translation for Calciphylaxis

    Details : Vitamin K1 is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Calciphylaxis.

    Product Name : Undisclosed

    Product Type : Vitamins/Minerals/Inorganic Salts

    Upfront Cash : Inapplicable

    August 24, 2021

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    Only 10 entries up to this point, click to access all click full view read-more
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    FDF Dossiers

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    01

    Biophore India Pharmaceuticals Pvt ...

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1A6
    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Flag India
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    Regulatory Info :

    Registration Country : India

    Phytonadione

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Biophore

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    02

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    PHYTONADIONE

    Brand Name : PHYTONADIONE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date : 2019-05-22

    Application Number : 207719

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    03

    Bausch & Lomb Incorporated

    Canada
    The MedTech Conference
    Not Confirmed
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    Bausch & Lomb Incorporated

    Canada
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
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    Flag Canada
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    Regulatory Info : DISCN

    Registration Country : USA

    PHYTONADIONE

    Brand Name : MEPHYTON

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 10104

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    F. Hoffmann-La Roche

    Switzerland
    The MedTech Conference
    Not Confirmed
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    F. Hoffmann-La Roche

    Switzerland
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    PHYTONADIONE

    Brand Name : KONAKION

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/0.5ML

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 11745

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    F. Hoffmann-La Roche

    Switzerland
    The MedTech Conference
    Not Confirmed
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    F. Hoffmann-La Roche

    Switzerland
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Switzerland
    Virtual Booth Virtual Booth
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    Regulatory Info : DISCN

    Registration Country : USA

    PHYTONADIONE

    Brand Name : KONAKION

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 11745

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Hospira, Inc.

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Hospira, Inc.

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
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    Flag U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

    Brand Name : M.V.I. PEDIATRIC

    Dosage Form : FOR SOLUTION;INTRAVENOUS

    Dosage Strength : 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

    Packaging :

    Approval Date : 2000-09-21

    Application Number : 18920

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Hospira, Inc.

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Hospira, Inc.

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed
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    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E

    Brand Name : VITAPED

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10

    Packaging :

    Approval Date : 1993-12-29

    Application Number : 20176

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    PAI Pharmaceutical Associates

    U.S.A
    The MedTech Conference
    Not Confirmed
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    PAI Pharmaceutical Associates

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    PHYTONADIONE

    Brand Name : AQUAMEPHYTON

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 12223

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    PAI Pharmaceutical Associates

    U.S.A
    The MedTech Conference
    Not Confirmed
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    PAI Pharmaceutical Associates

    U.S.A
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    PHYTONADIONE

    Brand Name : AQUAMEPHYTON

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 12223

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Sandoz B2B

    Switzerland
    The MedTech Conference
    Not Confirmed
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    Sandoz B2B

    Switzerland
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

    Brand Name : INFUVITE ADULT

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

    Packaging :

    Approval Date : 2000-05-18

    Application Number : 21163

    Regulatory Info : RX

    Registration Country : USA

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    DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 10104

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    DOSAGE - INJECTABLE;INJECTION - 10MG/ML ***Fe...DOSAGE - INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 12223

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    DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML **F...DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 12223

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    DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

    USFDA APPLICATION NUMBER - 18920

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    DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

    USFDA APPLICATION NUMBER - 21163

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    DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

    USFDA APPLICATION NUMBER - 21163

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    DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

    USFDA APPLICATION NUMBER - 21625

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    DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML

    USFDA APPLICATION NUMBER - 83722

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    DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML

    USFDA APPLICATION NUMBER - 87954

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    DOSAGE - INJECTABLE;INJECTION - 10MG/ML

    USFDA APPLICATION NUMBER - 87955

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    ABOUT THIS PAGE

    Looking for 84-80-0 / Vitamin K1 API manufacturers, exporters & distributors?

    Vitamin K1 manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Vitamin K1 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 Vitamin K1 manufacturer or Vitamin K1 supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin K1 manufacturer or Vitamin K1 supplier.

    PharmaCompass also assists you with knowing the Vitamin K1 API Price utilized in the formulation of products. Vitamin K1 API Price is not always fixed or binding as the Vitamin K1 Price is obtained through a variety of data sources. The Vitamin K1 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Vitamin K1

    Synonyms

    Phylloquinone, Phytonadione, 84-80-0, Phytomenadione, Phytylmenadione, 3-phytylmenadione

    Cas Number

    84-80-0

    Unique Ingredient Identifier (UNII)

    MLF3D1712D

    About Vitamin K1

    A family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic bacteria. Vitamin K1 has antihemorrhagic and prothrombogenic activity.

    Mephyton Manufacturers

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

    Mephyton Suppliers

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

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

    Mephyton USDMF

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

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

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

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

    Mephyton CEP

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

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

    Mephyton WC

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

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

    Mephyton 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 Mephyton as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Mephyton GMP

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

    Mephyton CoA

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

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

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