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    Chemistry

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    Also known as: 61-73-4, Basic blue 9, Methylthioninium chloride, Solvent blue 8, Swiss blue, Chromosmon
    Molecular Formula
    C16H18ClN3S
    Molecular Weight
    319.9  g/mol
    InChI Key
    CXKWCBBOMKCUKX-UHFFFAOYSA-M
    FDA UNII
    8NAP7826UB
    Methylene Blue
    A compound consisting of dark green crystals or crystalline powder, having a bronze-like luster. Solutions in water or alcohol have a deep blue color. Methylene blue is used as a bacteriologic stain and as an indicator. It inhibits GUANYLATE CYCLASE, and has been used to treat cyanide poisoning and to lower levels of METHEMOGLOBIN.
    1 2D Structure

    Methylene Blue

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [7-(dimethylamino)phenothiazin-3-ylidene]-dimethylazanium;chloride
    2.1.2 InChI
    InChI=1S/C16H18N3S.ClH/c1-18(2)11-5-7-13-15(9-11)20-16-10-12(19(3)4)6-8-14(16)17-13;/h5-10H,1-4H3;1H/q+1;/p-1
    2.1.3 InChI Key
    CXKWCBBOMKCUKX-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CN(C)C1=CC2=C(C=C1)N=C3C=CC(=[N+](C)C)C=C3S2.[Cl-]
    2.2 Other Identifiers
    2.2.1 UNII
    8NAP7826UB
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Basic Blue 9

    2. Blue 9, Basic

    3. Blue N, Methylene

    4. Blue, Methylene

    5. Blue, Swiss

    6. Blue, Urolene

    7. Chromosmon

    8. Methylene Blue N

    9. Methylthionine Chloride

    10. Methylthioninium Chloride

    11. Swiss Blue

    12. Urolene Blue

    2.3.2 Depositor-Supplied Synonyms

    1. 61-73-4

    2. Basic Blue 9

    3. Methylthioninium Chloride

    4. Solvent Blue 8

    5. Swiss Blue

    6. Chromosmon

    7. Methylene Blue Anhydrous

    8. 3,7-bis(dimethylamino)phenothiazin-5-ium Chloride

    9. Methylene Blue N

    10. Methylene Blue Bb

    11. C.i. Basic Blue 9

    12. Methylenium Ceruleum

    13. Tetramethylthionine Chloride

    14. Bleu De Methylene

    15. Methylene Blue Chloride

    16. Methylthionine Chloride

    17. External Blue 1

    18. Methylene Blue A

    19. Methylene Blue B

    20. Methylene Blue D

    21. Methylene Blue G

    22. Calcozine Blue Zf

    23. Methylene Blue Bd

    24. Methylene Blue Bp

    25. Methylene Blue Bx

    26. Methylene Blue Bz

    27. Methylene Blue Fz

    28. Methylene Blue Gz

    29. Methylene Blue Nz

    30. Methylene Blue Sg

    31. Methylene Blue Sp

    32. Methylene Blue Zf

    33. Methylene Blue Zx

    34. Tetramethylene Blue

    35. Methylene Blue 2b

    36. Methylene Blue Bba

    37. Methylene Blue Bpc

    38. Methylene Blue Hgg

    39. Methylene Blue Iad

    40. Methylene Blue Jfa

    41. Sandocryl Blue Brl

    42. Methylenblau

    43. Methylene Blue 2bf

    44. Methylene Blue 2bn

    45. Methylene Blue 2bp

    46. M-b Tabs

    47. Rember

    48. Mitsui Methylene Blue

    49. Methylthionium Chloride

    50. Leather Pure Blue Hb

    51. Modr Methylenova

    52. Schultz No. 1038

    53. Aizen Methylene Blue Bh

    54. Aizen Methylene Blue Fz

    55. Methylene Blue Polychrome

    56. Methylene Blue Zinc Free

    57. C.i. 52015

    58. Yamamoto Methylene Blue B

    59. D And C Blue Number 1

    60. Methylene Blue (medicinal)

    61. Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, Chloride

    62. Yamamoto Methylene Blue Zf

    63. Ext D And C Blue No. 1

    64. Methylene Blue I (medicinal)

    65. Cloruro De Metiltioninio

    66. Methylene Blue Nf (medicinal)

    67. Methylthioninii Chloridum

    68. Hidaco Methylene Blue Salt Free

    69. Methylene Blue Bb (zinc Free)

    70. Methylene Blue Usp (medicinal)

    71. Lowacryl Blue 9

    72. Chlorure De Methylthioninium

    73. Methylene Blue Usp Xii (medicinal)

    74. 3,7-bis(dimethylamino)phenazathionium Chloride

    75. Methylene Blue Chloride (biological Stain)

    76. X 138

    77. Mfcd00012111

    78. 12262-49-6

    79. Ci 52015

    80. Ci-52015

    81. 8nap7826ub

    82. Chebi:6872

    83. 105504-42-5

    84. Methylthioninium Chloride [inn]

    85. [7-(dimethylamino)phenothiazin-3-ylidene]-dimethylazanium;chloride

    86. Urolene Blue

    87. Provayblue

    88. Nsc-215213

    89. Nsc-617593

    90. Azul De Metileno

    91. Dsstox_cid_3296

    92. N-[7-(dimethylamino)-3h-phenothiazin-3-ylidene]-n-methylmethanaminium Chloride

    93. Ceruleum Methylenum

    94. Dsstox_rid_76963

    95. Dsstox_gsid_23296

    96. Methylenum Coeruleum

    97. Ci Basic Blue 9

    98. Zinc Free Methylene Blue

    99. Caswell No. 567

    100. Methylenblau [german]

    101. Methylthionini Chloridum

    102. 3h-phenothiazine, 3-methochloride

    103. Trx0014

    104. Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, Chloride (1:1)

    105. Modr Methylenova [czech]

    106. Chembl405110

    107. Modr Zasadita 9

    108. Modr Zasadita 9 [czech]

    109. Cas-61-73-4

    110. N-(7-(dimethylamino)-3h-phenothiazin-3-ylidene)-n-methylmethanaminium Chloride

    111. Nsc3089

    112. 152071-32-4

    113. Ccris 833

    114. Metiltioninio Cloruro [dcit]

    115. Metiltioninio Cloruro

    116. Modr Rozpoustedlova 8 [czech]

    117. 3h-phenothiazine, 7-(dimethylamino)-3-(methylimino)-, 3-methochloride

    118. Modr Rozpoustedlova 8

    119. Nsc215213

    120. Nsc617593

    121. C.i. 52 015

    122. Hsdb 1405

    123. Ncgc00167496-01

    124. Ncgc00167496-03

    125. Phenothiazin-5-ium,7-bis(dimethylamino)-, Chloride

    126. Einecs 200-515-2

    127. Methylthioninii Chloridum [inn-latin]

    128. Epa Pesticide Chemical Code 039505

    129. Nsc 215213

    130. Cloruro De Metiltioninio [inn-spanish]

    131. Unii-8nap7826ub

    132. Wln: T C666 Bs Ey Inj Euk1&1 Mn1&1 &g &421

    133. Chlorure De Methylthioninium [inn-french]

    134. Methylene Blue Usp

    135. Methylene Azure Ii

    136. Prestwick_326

    137. Methylene Blue (inhibitor)

    138. Schembl1351

    139. Methylene Blue [mi]

    140. Mls000719838

    141. Methylene Blue [hsdb]

    142. Basic Blue 9 [inci]

    143. Dog (couch) Grass Powder

    144. Dtxsid0023296

    145. Hms2598o03

    146. Pharmakon1600-01505444

    147. Ci No 52015

    148. Nsc-3089

    149. Trx-0014

    150. Tox21_112497

    151. Tox21_302087

    152. Nsc759135

    153. S4535

    154. Stk018918

    155. Akos000486124

    156. Akos015916406

    157. Tox21_112497_1

    158. Ccg-267696

    159. Db09241

    160. 4-(1-hydroxy-ethyl)-benzoicacid

    161. Methylthioninium Chloride [mart.]

    162. Ncgc00255351-01

    163. Ac-15225

    164. As-35256

    165. Basic Blue 9;tetramethylthionine Chloride

    166. Hy-14536

    167. Methylene Blue, 1% W/v Aqueous Solution

    168. Methylthioninium Chloride [who-dd]

    169. Methylthioninium Chloride Proveblue

    170. Smr000304367

    171. Sy076497

    172. Methylthioninium Chloride (methylene Blue)

    173. Methylene Blue (c.i. 52015) Biochemica

    174. Methylthioninium Chloride [ema Epar]

    175. A0574

    176. Ft-0622580

    177. M0501

    178. M2392

    179. C00220

    180. M-3598

    181. Methylthioninium Chloride [ep Impurity]

    182. 3,7-bis(dimethylamino)-5-phenothiazinium Chloride

    183. Q422134

    184. Methylthioninium Chloride Anhydrous [who-ip]

    185. 3,7-bis(dimethylamino)-phenothiazin-5-ium Chloride Salt

    186. Methylthioninii Chloridum Anhydrous [who-ip Latin]

    187. Methylene Blue Solution (methanol Solution) [for Cell Staining]

    188. 3-n,3-n,7-n,7-n-tetramethylphenothiazin-5-ium-3,7-diamine;chloride

    189. N-(7-(dimethylamino)-3h-phenothiazin-3-ylidene)-n-methylmethanaminiumchloride

    190. 1341-90-8

    191. 6476-03-5

    192. 97130-83-1

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 319.9 g/mol
    Molecular Formula C16H18ClN3S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count1
    Exact Mass319.0909965 g/mol
    Monoisotopic Mass319.0909965 g/mol
    Topological Polar Surface Area43.9 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity483
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Enzyme Inhibitors

    National Library of Medicine's Medical Subject Headings. Methylene Blue. Online file (MeSH, 2018). Available from, as of August 29, 2018: https://meshb.nlm.nih.gov/search

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

    NIH/NLM; ClinicalTrials.Gov. Available from, as of August 29, 2018: https://clinicaltrials.gov/

    Drug-induced methemoglobinemia. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Methylene blue injection (Updated: November 20, 2017). Available from, as of September 5, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fde64824-2be5-4d85-8d57-5098ca6890bb

    Methylene blue posses weak urinary antiseptic properties. Methylene blue directly inhibits calcium binding by oxalate and by organic stone matrix. The drug also acts as a crystal poison at the interface, reducing the tendency of calcium oxalate particles to aggregate. In addition, it reverses intracellular acidosis (such as that in renal tubule acidosis), apparently by competing with diphosphopyridine nucleotide as a hydrogen receptor.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    For more Therapeutic Uses (Complete) data for Methylene blue (32 total), please visit the HSDB record page.

    4.2 Drug Warning

    /BOXED WARNING/ WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS. Methylene Blue Injection may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs. Avoid concomitant use of Methylene blue injection with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors.

    NIH; DailyMed. Current Medication Information for Methylene blue injection (Updated: November 20, 2017). Available from, as of September 5, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fde64824-2be5-4d85-8d57-5098ca6890bb

    Large IV doses of methylene blue may produce nausea, vomiting, abdominal pain, precordial pain, dizziness, headache, profuse sweating, dyspnea, hypertension, and mental confusion. Urinary tract irritation may occur. High IV dosage or high local concentrations of methylene blue may cause formation of methemoglobin and cyanosis.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    Hemolysis and hemolytic anemia may occur, especially in young infants and patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    Hypersensitivity, manifested as wheal and flare reactions at the injection site, has been reported. Severe hypersensitivity reactions, including anaphylaxis, generalized urticaria, and hypotension, tachycardia, and bronchospasm, have been reported following local instillation or injection of methylene blue.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    For more Drug Warnings (Complete) data for Methylene blue (20 total), please visit the HSDB record page.

    4.3 Drug Indication

    Indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Other clinical applications of methylene blue include improvement of hypotension associated with various clinical states, an antiseptic in urinary tract infections, treatment of hypoxia and hyperdynamic circulation in cirrhosis of liver and severe hepatopulmonary syndrome, and treatment of ifofosamide induced neurotoxicity.

    Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.

    Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Enzyme Inhibitors

    Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Oxidation-Reduction Agent [EPC]; Oxidation-Reduction Activity [MoA]
    5.3 ATC Code

    V03AB17

    V - Various

    V03 - All other therapeutic products

    V03A - All other therapeutic products

    V03AB - Antidotes

    V03AB17 - Methylthioninium chloride

    V - Various

    V04 - Diagnostic agents

    V04C - Other diagnostic agents

    V04CG - Tests for gastric secretion

    V04CG05 - Methylthioninium chloride

    5.4 Absorption, Distribution and Excretion

    Route of Elimination

    Excreted in urine and bile. About 75% of an oral dose excreted in urine, primarily as stabilized colorless leukomethylene blue.

    Volume of Distribution

    10 mg/kg (in rats).

    Clearance

    3.00.7 L/min.

    ... The concentration of methylene blue in whole blood was measured using high-performance liquid chromatography in seven volunteers after IV and oral administration of 100 mg methylene blue with and without mesna. The distribution of methylene blue in different tissues was measured in rats after intraduodenal and IV application. The time course of methylene blue in whole blood after IV administration showed a multiphasic time course with an estimated terminal half-life of 5.25 hr. Following oral administration, the area under the concentration-time curve was much lower (9 nmol/min/mL vs 137 nmol/min/mL). Co-administration of mesna, which could influence distribution by ion-pairing, did not alter the pharmacokinetics. The urinary excretion of methylene blue and its leukoform was only moderately higher after IV administration (18% vs 28% dose). Intraduodenal administration to rats resulted in higher concentrations in intestinal wall and liver but lower concentrations in whole blood and brain than IV methylene blue. Differences in organ distribution of methylene blue are mainly responsible for the different pharmacokinetics after oral and IV administration. ...

    PMID:10952480 Peter C et al; Eur J Clin Pharmacol 56 (3): 247-50 (2000)

    Methylene blue is well absorbed from the GI tract, and peak plasma concentrations occur approximately 1-2 hours after an oral dose. ... Following distribution into tissues, methylene blue is rapidly reduced to leukomethylene blue (leucomethylthioninium chloride). Metabolism to leucomethylene blue may be less efficient in neonates than in older individuals. Methylene blue is excreted in urine and bile. About 75% of an oral dose of methylene blue is excreted in urine, mostly as stabilized colorless leukomethylene blue. On exposure to air, the urine turns green or blue, due to the presence of the oxidation product methylene azure (methylene blue sulfone). Some unchanged drug is also excreted in urine.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    BACKGROUND: Although blue dye is routinely used for lymphatic mapping, it is not used for lymphatic mapping in pregnancy-associated breast cancer, because of concern of fetal risk. METHODS: To investigate the safety of blue dye for lymphatic mapping in pregnant women, the pharmacokinetics of methylene blue dye were examined in 10 nonpregnant women, and the results were extrapolated to estimate maximal fetal exposure to the dye. RESULTS: Plasma and urine measurements indicated that the dye quickly distributed from the breast injection site to the circulation, with 32% of the total dose excreted in urine within 48 hours. Combined with existing data on organ distribution of methylene blue, the estimated maximal dose to the fetus is 0.25 mg (5% of the administered dose), likely further reduced by other physiologic factors related to pregnancy. CONCLUSIONS: The analysis suggests that methylene blue dye can be used for lymphatic mapping in pregnancy-associated breast cancer with minimal fetal risk.

    PMID:21167367 Pruthi S et al; Am J Surg 201 (1): 70-5 (2011)

    The disposition and urinary excretion pharmacokinetics of methylene blue were determined after its intravenous administration at 15 mg/kg to mature female sheep. Comparisons were made between methylene blue administered alone or subsequent to 50 mg/kg sodium nitrite. The overall elimination rate constant (beta) of methylene blue, 0.0076 +/- 0.0016 min-1, was not influenced by prior administration of sodium nitrite. However, the distribution rate was significantly altered by sodium nitrite. Very little of the methylene blue was eliminated in the urine either intact or as leukomethylene blue in spite of its relatively short half life. ...

    PMID:6492250 Burrows GE; J Vet Pharmacol Ther 7 (3): 225-31(1984)

    5.5 Metabolism/Metabolites

    Following distribution into tissues, rapidly reduced to leukomethylene blue (leucomethylthioninium chloride). Metabolism to leucomethylene blue may be less efficient in neonates than in older individuals.

    Methylene blue can be reduced to a colorless form, leukomethylene blue; together, these compounds form a reversible oxidation-reduction system. In low concentrations, methylene blue accelerates conversion of methemoglobin to hemoglobin. In patients with methemoglobinemia, methylene blue is reduced to leukomethylene blue by methemoglobin reductases in erythrocytes; leukomethylene blue then reduces methemoglobin to hemoglobin. In high concentrations, methylene blue oxidizes the ferrous iron of reduced hemoglobin to the ferric state, thereby changing hemoglobin to methemoglobin.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    Following distribution into tissues, methylene blue is rapidly reduced to leukomethylene blue (leucomethylthioninium chloride). Metabolism to leucomethylene blue may be less efficient in neonates than in older individuals.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    5.6 Biological Half-Life

    56.5 hours (after IV dose).

    Following IV administration, the estimated half-life of methylene blue is 5-6.5 hours.

    American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

    ... The concentration of methylene blue in whole blood was measured using high-performance liquid chromatography in seven volunteers after IV and oral administration of 100 mg methylene blue with and without mesna. The distribution of methylene blue in different tissues was measured in rats after intraduodenal and IV application. The time course of methylene blue in whole blood after IV administration showed a multiphasic time course with an estimated terminal half-life of 5.25 hr. ...

    PMID:10952480 Peter C et al; Eur J Clin Pharmacol 56 (3): 247-50 (2000)

    5.7 Mechanism of Action

    * Main mechanism of action involves inhibition of nitric oxide synthase and guanylate cyclase. * In Alzheimers Disease: a mechanistic study found that methylene blue oxidizes cysteine sulfhydryl groups on tau to keep tau monomeric. One preclinical treatment study in tauopathy mice reported anti-inflammatory or neuroprotective effects mediated by the Nrf2/antioxidant response element (ARE); another reported insoluble tau reduction and a learning and memory benefit when given early. * In Methemoglobinemia: Methylene Blue acts by reacting within RBC to form leukomethylene blue, which is a reducing agent of oxidized hemoglobin converting the ferric ion (fe+++) back to its oxygen-carrying ferrous state(fe++). * As antimalarial agent: Methylene Blue, a specific inhibitor of P.falciparum glutathione reductase has the potential to reverse CQ resistance and it prevents the polymerization of haem into haemozoin similar to 4-amino-quinoline antimalarials. * For ifosfamide induced neurotoxicity: Methylene blue functions as an alternate electron acceptor. It acts to reverse the NADH inhibition caused by gluconeogenesis in the liver while blocking the transformation of chloroethylamine into chloroacetaldehyde. In addition, it inhibits various amine oxidase activities, which also prevents the formation of chloroacetaldehyde.

    The mechanism of modulation of cyclic guanosine monophosphate accumulation by methylene blue, a putative inhibitor of soluble guanylate cyclase, was investigated in cultured rabbit pulmonary arterial smooth muscle cells. Control or methylene blue pretreated rabbit pulmonary arterial smooth muscle were stimulated with sodium nitroprusside, nitrosothiols or endothelium derived relaxing factor released basally from bovine pulmonary arterial endothelial cells, in short term cocultures. The putative endothelium-derived relaxing factor, S-nitroso-L-cysteine, a stab1e deaminated analog of S-nitroso-L-cysteine, S-nitroso-3-mercaptoproprionic acid and sodium nitroprusside produced concentration-dependent (1-100 uM) increase (1.5- to 12-fold) in rabbit pulmonary arterial smooth muscle cells cyclic guanosine monophospate levels. Methylene blue pretreatment inhibited S-nitroso-L-cysteine and sodium nitroprusside induced cyclic guanosine monophosphate accumulation by 51% to 100%, but S-nitroso-3-mercaptoproprionic acid mediated responses were not altered by methylene blue. The inhibition profile of methylene blue on nitrovasodilator induced cyclic guanosine monophosphate accumulation was quantitatively reproduced by extracellular generation of superoxide anion with xanthine (100 uM) and xanthine oxidase (5 mU). Similarly to methylene blue pretreatment, superoxide anion generation had no effects on base-line cyclic guanosine phosphate levels or cyclic guanosine phosphate responses elicited by S-nitroso-3-mercaptoproprionic acid. Furthermore, methylene blue induced a dose and time dependent generation of superoxide anion from rabbit pulmonary arterial smooth muscle cells, as evidenced from spectrophotometric determination of cytochrome c reduction. Inhibition of cyclic guanosine monophosphate accumulation in response to S-nitroso-L-cysteine and sodium nitroprusside by methylene blue was completely prevented by superoxide dismutase but not catalase. Selective pretreatment of endothelial cells with methylene blue before co-culture with untreated rabbit pulmonary arterial smooth muscle produced a reduction in rabbit pulmonary arterial smooth muscle cyclic guanosine monophosphate levels of a magnitude comparable with that seen in cocultures of methylene blue pretreated rabbit pulmonary arterial smooth muscle with untreated endothelial cells, and which was partially prevented by superoxide dismutase.

    PMID:1328604 Marczin N et al; J Pharmacol Exp Ther 263 (1): 170-9 (1992)

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    Pharmazell Gmbh

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    Chemwerth Inc

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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Macsen Drugs

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    Macsen Drugs

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    Sichuan Qingmu Pharmaceutical Co Ltd

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    Virtual BoothSichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.

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    DMF Review : Complete

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    06

    Chemcon Gmbh

    Germany

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    EPSC
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    Chemcon Gmbh

    Germany
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-10-25

    Pay. Date : 2022-07-01

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    Icrom Srl

    Italy

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    Icrom Srl

    Italy
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    DMF Review : Complete

    Rev. Date : 2022-01-25

    Pay. Date : 2021-12-16

    DMF Number : 36307

    Submission : 2021-12-02

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    EPSC
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    Iso Tex Diagnostics Inc

    U.S.A
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    Not Confirmed

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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 17684

    Submission : 2004-09-09

    Status : Inactive

    Type : II

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    09

    EPSC
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    Luitpold Pharmaceuticals Inc

    U.S.A
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 15237

    Submission : 2000-12-28

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    10

    Mikrochem Spol Sro

    Slovakia

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    Mikrochem Spol Sro

    Slovakia
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    DMF Review : Complete

    Rev. Date : 2023-02-23

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    DMF Number : 31694

    Submission : 2017-07-05

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    CEP/COS

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    PharmaZell GmbH Raubling DE

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    Methylthioninium chloride hydrate

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    CEP 2023-129 - Rev 00
    Valid
    Chemical
    2024-09-27
    1132
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    01

    PharmaZell GmbH Raubling DE

    Germany
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    Methylthioninium Chloride Hydrate

    Certificate Number : CEP 2023-129 - Rev 00

    Status : Valid

    Issue Date : 2024-09-27

    Type : Chemical

    Substance Number : 1132

    Axplora CB

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    Becton, Dickinson and Company Spark...

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    Loeffler Medium, Product code: 292946

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    R1-CEP 2000-328 - Rev 02
    Valid
    TSE
    2012-07-25
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    Becton, Dickinson and Company Spark...

    United Kingdom
    EPSC
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    ICROM S.R.L. Concorezzo IT

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    Methylthioninium chloride hydrate

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    CEP 2022-296 - Rev 01
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    Chemical
    2025-02-05
    1132
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    ICROM S.R.L. Concorezzo IT

    Italy
    EPSC
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648578600,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328,,SANJEEV AREDDY NAGAR,","city":"HYDERABAD,TELANGANA","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. 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K","customer":"RK PHARMA INC","customerCountry":"UNITED STATES","quantity":"8.89","actualQuantity":"8.89","unit":"KGS","unitRateFc":"10600","totalValueFC":"91784.8","currency":"USD","unitRateINR":859730.03374578175,"date":"03-Nov-2023","totalValueINR":"7643000","totalValueInUsd":"91784.8","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"5120176","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.154\/A\/6, SY NO.172-A,, ","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701455400,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"UNDISCLOSED","customerCountry":"UNITED STATES","quantity":"25.63","actualQuantity":"25.628","unit":"KGS","unitRateFc":"2000","totalValueFC":"50490.6","currency":"USD","unitRateINR":164000.31215857656,"date":"02-Dec-2023","totalValueINR":"4203000","totalValueInUsd":"50490.6","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"5760021","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE PHARMA INC","customerCountry":"UNITED STATES","quantity":"21.37","actualQuantity":"21.372","unit":"KGS","unitRateFc":"2000","totalValueFC":"42273.7","currency":"USD","unitRateINR":164654.68837731611,"date":"30-Dec-2023","totalValueINR":"3519000","totalValueInUsd":"42273.7","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"6424128","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704479400,"product":"METHYLENE BLUE USP","address":"PLOT NO.154\/A\/6, SY NO.172-A,","city":"","supplier":"AKTINOS PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"RK PHARMA INC","customerCountry":"UNITED STATES","quantity":"3.93","actualQuantity":"3.93","unit":"KGS","unitRateFc":"10600","totalValueFC":"39282","currency":"USD","unitRateINR":830736.13231552159,"date":"06-Jan-2024","totalValueINR":"3264793","totalValueInUsd":"39282","indian_port":"Hyderabad Air","hs_no":"29333100","bill_no":"6564667","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.154\/A\/6, SY NO.172-A,, ","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710441000,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. 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K","customer":"BIOPHORE PHARMA INC","customerCountry":"UNITED STATES","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"2000","totalValueFC":"7937.6","currency":"USD","unitRateINR":171883.75,"date":"19-Mar-2025","totalValueINR":"687535","totalValueInUsd":"7937.6","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"9127457","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743618600,"product":"METHYLENE BLUE USP.","address":"N\/A","city":"N\/A","supplier":"SCH GLOBAL SERVICES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MIAMI, FL","customer":"DARMERICA LLC","customerCountry":"UNITED STATES","quantity":"24.32","actualQuantity":"24.32","unit":"KGS","unitRateFc":"4900","totalValueFC":"104565.8","currency":"USD","unitRateINR":368051.8421052632,"date":"03-Apr-2025","totalValueINR":"8951020.8","totalValueInUsd":"104565.8","indian_port":"Bombay Air","hs_no":"29239000","bill_no":"9630286","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743618600,"product":"METHYLENE BLUE USP.","address":"N\/A","city":"N\/A","supplier":"SCH GLOBAL SERVICES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MIAMI, FL","customer":"DARMERICA LLC","customerCountry":"UNITED STATES","quantity":"24.32","actualQuantity":"24.32","unit":"KGS","unitRateFc":"4900","totalValueFC":"104565.8","currency":"USD","unitRateINR":368051.8421052632,"date":"03-Apr-2025","totalValueINR":"8951020.8","totalValueInUsd":"104565.8","indian_port":"Bombay Air","hs_no":"29239000","bill_no":"9630798","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746469800,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE PHARMA INC","customerCountry":"UNITED STATES","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2000","totalValueFC":"3728.1","currency":"USD","unitRateINR":158820,"date":"06-May-2025","totalValueINR":"317640","totalValueInUsd":"3728.1","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"1550606","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746469800,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"CROSS FREIGHT GMBH","customerCountry":"GERMANY","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2000","totalValueFC":"19663.6","currency":"USD","unitRateINR":167535,"date":"06-May-2025","totalValueINR":"1675350","totalValueInUsd":"19663.6","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"1551133","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328,, HYDERABAD, AP.","customerAddress":""}]
    30-Mar-2022
    06-May-2025
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    Drugs in Development

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    • Development Update
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    Nexus Pharmaceuticals Launches Methylene Blue Injection

    Details:

    Methylene blue is a monoamine oxidase inhibitor, indicated for the treatment of methemoglobinemia.


    Lead Product(s): Methylene Blue,Inapplicable

    Therapeutic Area: Hematology Brand Name: Methylene Blue-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 22, 2025

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    01

    Nexus Pharmaceuticals

    U.S.A
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    EPSC
    Not Confirmed

    Nexus Pharmaceuticals

    U.S.A
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    EPSC
    Not Confirmed
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    Lead Product(s) : Methylene Blue,Inapplicable

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Nexus Pharmaceuticals Launches Methylene Blue Injection

    Details : Methylene blue is a monoamine oxidase inhibitor, indicated for the treatment of methemoglobinemia.

    Product Name : Methylene Blue-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 22, 2025

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    Ondine Recruits First Patient for US Phase 3 Trial

    Details:

    Nasal antimicrobial photodisinfection therapy consisiting of NF-031 (methylthioninium chloride & chlorhexidine gluconate) is being evaluated for treatment of surgical site infections.


    Lead Product(s): Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 30, 2024

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    02

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed
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    Lead Product(s) : Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Ondine Recruits First Patient for US Phase 3 Trial

    Details : Nasal antimicrobial photodisinfection therapy consisiting of NF-031 (methylthioninium chloride & chlorhexidine gluconate) is being evaluated for treatment of surgical site infections.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 30, 2024

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    Nexus Pharmaceuticals Receives FDA Approval for Methylene Blue Injection, USP

    Details:

    The US FDA approved Methylene Blue Injection, USP (methylene blue). It is an oxidation-reduction agent that offers treatment of acquired methemoglobinemia.


    Lead Product(s): Methylene Blue,Inapplicable

    Therapeutic Area: Hematology Brand Name: Methylene Blue Injection, USP

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 26, 2024

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    03

    Nexus Pharmaceuticals

    U.S.A
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    EPSC
    Not Confirmed

    Nexus Pharmaceuticals

    U.S.A
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    EPSC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Methylene Blue,Inapplicable

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Nexus Pharmaceuticals Receives FDA Approval for Methylene Blue Injection, USP

    Details : The US FDA approved Methylene Blue Injection, USP (methylene blue). It is an oxidation-reduction agent that offers treatment of acquired methemoglobinemia.

    Product Name : Methylene Blue Injection, USP

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 26, 2024

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    Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

    Details:

    Undisclosed


    Lead Product(s): Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 25, 2024

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    04

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed
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    Lead Product(s) : Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

    Details : Undisclosed

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 25, 2024

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    Ondine Biomedical Completes Patient Recruitment for US Phase II Nasal Photodisinfection Trial

    Details:

    Photodynamic Antimicrobial Chemotherapy (PACT) using methylene blue is a potential antimicrobial therapy that combines light and a photosensitizing drug, promoting a phototoxic effect on the treated cells increases membrane permeability in Candida albicans.


    Lead Product(s): Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: PACT

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Healthcare's Memorial Health University Medical Center

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 08, 2022

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    05

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed
    • fda
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    Lead Product(s) : Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Healthcare's Memorial Health University Medical Center

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Ondine Biomedical Completes Patient Recruitment for US Phase II Nasal Photodisinfection Trial

    Details : Photodynamic Antimicrobial Chemotherapy (PACT) using methylene blue is a potential antimicrobial therapy that combines light and a photosensitizing drug, promoting a phototoxic effect on the treated cells increases membrane permeability in Candida albica...

    Product Name : PACT

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 08, 2022

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    American Regent Launches a New Vial Presentation

    Details:

    ProvayBlue (methylene blue) is hypotonic and may be diluted before use in a solution of 50 mL 5% Dextrose Injection in order to avoid local pain, particularly in the pediatric population. Use the diluted solution immediately after preparation.


    Lead Product(s): Methylene Blue,Inapplicable

    Therapeutic Area: Hematology Brand Name: ProvayBlue

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Provepharm Life Solutions

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 30, 2022

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    06

    American Regent

    U.S.A
    arrow
    EPSC
    Not Confirmed

    American Regent

    U.S.A
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    EPSC
    Not Confirmed
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    Lead Product(s) : Methylene Blue,Inapplicable

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Provepharm Life Solutions

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    American Regent Launches a New Vial Presentation

    Details : ProvayBlue (methylene blue) is hypotonic and may be diluted before use in a solution of 50 mL 5% Dextrose Injection in order to avoid local pain, particularly in the pediatric population. Use the diluted solution immediately after preparation.

    Product Name : ProvayBlue

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 30, 2022

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    Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures

    Details:

    Undisclosed


    Lead Product(s): Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 25, 2021

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    07

    Ondine Biomedical

    Canada
    arrow
    EPSC
    Not Confirmed

    Ondine Biomedical

    Canada
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    EPSC
    Not Confirmed
    • fda
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    Lead Product(s) : Methylene Blue,Chlorhexidine Gluconate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Proced...

    Details : Undisclosed

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 25, 2021

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    Methylene Blue as a Third-line Vasopressor in Septic Shock

    Details:

    Undisclosed


    Lead Product(s): Phenylephrine Hydrochloride,Methylene Blue

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

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Provepharm Life Solutions

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 13, 2019

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    08

    Carilion Clinic

    Country
    arrow
    EPSC
    Not Confirmed

    Carilion Clinic

    Country
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    EPSC
    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Phenylephrine Hydrochloride,Methylene Blue

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Provepharm Life Solutions

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Methylene Blue as a Third-line Vasopressor in Septic Shock

    Details : Undisclosed

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 13, 2019

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    3D Printing for Nodule Localization

    Details:

    Undisclosed


    Lead Product(s): Methylene Blue,Inapplicable

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Other Small Molecule

    Sponsor: Zhuhai Seine Technology Co., Ltd

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2019

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    09

    Wen-zhao ZHONG

    Country
    arrow
    EPSC
    Not Confirmed

    Wen-zhao ZHONG

    Country
    arrow
    EPSC
    Not Confirmed
    • fda
    • EDQM
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    Lead Product(s) : Methylene Blue,Inapplicable

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Zhuhai Seine Technology Co., Ltd

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    3D Printing for Nodule Localization

    Details : Undisclosed

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 14, 2019

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    Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

    Details:

    Undisclosed


    Lead Product(s): Methylene Blue,Indocyanine Green

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Other Small Molecule

    Sponsor: Beijing Digital Precision Medicine | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing Friendship Hospital | Tangshan People's Hospital | The Second Hospital of Hebei Medical University

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 09, 2018

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    10

    Chinese Academy of Sciences

    Country
    arrow
    EPSC
    Not Confirmed

    Chinese Academy of Sciences

    Country
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    EPSC
    Not Confirmed
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    Lead Product(s) : Methylene Blue,Indocyanine Green

    Therapeutic Area : Oncology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Beijing Digital Precision Medicine | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing Friendship Hospital | Tangshan People's Hospital | The Second Hospital of Hebei Medical University

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

    Details : Undisclosed

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 09, 2018

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    FDF Dossiers

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    01

    Frilab Laboratories

    Switzerland
    EPSC
    Not Confirmed
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    Frilab Laboratories

    Switzerland
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    METHYLENE BLUE

    Brand Name : COLLYRE BLEU LAITER

    Dosage Form : DROPS

    Dosage Strength : 0.2MG/ML

    Packaging : 10ML

    Approval Date :

    Application Number : 674354

    Regulatory Info :

    Registration Country : Canada

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    02

    Health Biotech

    India
    EPSC
    Not Confirmed
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    India
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : India

    Methylene Blue

    Brand Name :

    Dosage Form : Ampoule

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    03

    LABORATOIRE ATLAS INC

    Canada
    EPSC
    Not Confirmed
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    LABORATOIRE ATLAS INC

    Canada
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    METHYLENE BLUE

    Brand Name : METHYLENE BLEU LIQ 1%

    Dosage Form : LIQUID

    Dosage Strength : 1%

    Packaging : 25ML

    Approval Date :

    Application Number : 50466

    Regulatory Info :

    Registration Country : Canada

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    04

    Nexus Pharmaceuticals

    U.S.A
    EPSC
    Not Confirmed
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    Nexus Pharmaceuticals

    U.S.A
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    EPSC
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    METHYLENE BLUE

    Brand Name : METHYLENE BLUE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 50MG/10ML (5MG/ML)

    Packaging :

    Approval Date : 2024-11-21

    Application Number : 217561

    Regulatory Info : RX

    Registration Country : USA

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    05

    Phebra

    Australia
    EPSC
    Not Confirmed
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    Phebra

    Australia
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    METHYLENE BLUE

    Brand Name : METHYLENE BLUE INJECTION

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date :

    Application Number : 2487993

    Regulatory Info :

    Registration Country : Canada

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    06

    Steriscience

    India
    EPSC
    Not Confirmed
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    Steriscience

    India
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    EPSC
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    METHYLENE BLUE

    Brand Name : METHYLENE BLUE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 50MG/10ML (5MG/ML)

    Packaging :

    Approval Date : 2024-11-22

    Application Number : 216955

    Regulatory Info : RX

    Registration Country : USA

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    07

    Valdafrique

    Senegal
    EPSC
    Not Confirmed
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    Valdafrique

    Senegal
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Senegal

    Methylene Blue

    Brand Name :

    Dosage Form : Antiseptic Solution

    Dosage Strength : 2%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Senegal

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    08

    Zydus Lifesciences

    India
    EPSC
    Not Confirmed
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    Zydus Lifesciences

    India
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    EPSC
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    METHYLENE BLUE

    Brand Name : METHYLENE BLUE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 10MG/2ML (5MG/ML)

    Packaging :

    Approval Date : 2023-12-05

    Application Number : 215636

    Regulatory Info : RX

    Registration Country : USA

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    09

    Country
    EPSC
    Not Confirmed
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    Country
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Metiltioninio

    Dosage Form :

    Dosage Strength : 5 Vials 50 Mg 5 Ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Country
    EPSC
    Not Confirmed
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    Country
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Metiltioninio

    Dosage Form :

    Dosage Strength : Skin Soluz 25 Ml 100 Mg/10 Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Europe

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    01

    MONICO SpA

    Country
    EPSC
    Not Confirmed
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    MONICO SpA

    Country
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    EPSC
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Methylene Blue

    Dosage Form :

    Dosage Strength : 5 Vials 50 Mg 5 Ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    SALF SpA

    Country
    EPSC
    Not Confirmed
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    SALF SpA

    Country
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Metiltioninio

    Dosage Form :

    Dosage Strength : 5 Vials 50 Mg 5 Ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    MONICO SpA

    Country
    EPSC
    Not Confirmed
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    MONICO SpA

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    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Methylene Blue

    Dosage Form :

    Dosage Strength : 5 Ampoule 100 Mg 10 Ml

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    SALF SpA

    Country
    EPSC
    Not Confirmed
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    SALF SpA

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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Metiltioninio

    Dosage Form :

    Dosage Strength : 5 Ampoule 100 Mg 10 Ml

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    Approval Date :

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    Registration Country : Italy

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    05

    RAMINI SpA

    Country
    EPSC
    Not Confirmed
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    RAMINI SpA

    Country
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Methylene Blue

    Brand Name : Metiltioninio

    Dosage Form :

    Dosage Strength : Skin Soluz 25 Ml 100 Mg/10 Ml  

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Provepharm SAS

    Country
    EPSC
    Not Confirmed
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    Provepharm SAS

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    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Methylene Blue

    Brand Name : Methylthioninium chloride Prov Blue

    Dosage Form : Injection fluid, resolution

    Dosage Strength : 5 mg/ml

    Packaging : Ampoule

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Provepharm SAS

    Country
    EPSC
    Not Confirmed
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    Provepharm SAS

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    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Methylene Blue

    Brand Name : Methylthioninium chloride Prov Blue

    Dosage Form : Injection fluid, resolution

    Dosage Strength : 5 mg/ml

    Packaging : Ampoule

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Canada

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    FRILAB SA

    Switzerland
    EPSC
    Not Confirmed
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    FRILAB SA

    Switzerland
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    EPSC
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    METHYLENE BLUE

    Brand Name : COLLYRE BLEU LAITER

    Dosage Form : DROPS

    Dosage Strength : 0.2MG/ML

    Packaging : 10ML

    Approval Date :

    Application Number : 674354

    Regulatory Info :

    Registration Country : Canada

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    02

    LABORATOIRE ATLAS INC

    Canada
    EPSC
    Not Confirmed
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    LABORATOIRE ATLAS INC

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    ABOUT THIS PAGE

    Looking for 61-73-4 / Methylene Blue API manufacturers, exporters & distributors?

    Methylene Blue manufacturers, exporters & distributors 1

    24

    PharmaCompass offers a list of Methylene Blue 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 Methylene Blue manufacturer or Methylene Blue supplier for your needs.

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

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

    API | Excipient name

    Methylene Blue

    Synonyms

    61-73-4, Basic blue 9, Methylthioninium chloride, Solvent blue 8, Swiss blue, Chromosmon

    Cas Number

    61-73-4

    Unique Ingredient Identifier (UNII)

    8NAP7826UB

    About Methylene Blue

    A compound consisting of dark green crystals or crystalline powder, having a bronze-like luster. Solutions in water or alcohol have a deep blue color. Methylene blue is used as a bacteriologic stain and as an indicator. It inhibits GUANYLATE CYCLASE, and has been used to treat cyanide poisoning and to lower levels of METHEMOGLOBIN.

    CAS-61-73-4 Manufacturers

    A CAS-61-73-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-61-73-4, including repackagers and relabelers. The FDA regulates CAS-61-73-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-61-73-4 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 CAS-61-73-4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    CAS-61-73-4 Suppliers

    A CAS-61-73-4 supplier is an individual or a company that provides CAS-61-73-4 active pharmaceutical ingredient (API) or CAS-61-73-4 finished formulations upon request. The CAS-61-73-4 suppliers may include CAS-61-73-4 API manufacturers, exporters, distributors and traders.

    click here to find a list of CAS-61-73-4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    CAS-61-73-4 USDMF

    A CAS-61-73-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-61-73-4 active pharmaceutical ingredient (API) in detail. Different forms of CAS-61-73-4 DMFs exist exist since differing nations have different regulations, such as CAS-61-73-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A CAS-61-73-4 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-61-73-4 USDMF includes data on CAS-61-73-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-61-73-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of CAS-61-73-4 suppliers with USDMF on PharmaCompass.

    CAS-61-73-4 CEP

    A CAS-61-73-4 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-61-73-4 Certificate of Suitability (COS). The purpose of a CAS-61-73-4 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-61-73-4 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-61-73-4 to their clients by showing that a CAS-61-73-4 CEP has been issued for it. The manufacturer submits a CAS-61-73-4 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-61-73-4 CEP holder for the record. Additionally, the data presented in the CAS-61-73-4 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-61-73-4 DMF.

    A CAS-61-73-4 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-61-73-4 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 CAS-61-73-4 suppliers with CEP (COS) on PharmaCompass.

    CAS-61-73-4 WC

    A CAS-61-73-4 written confirmation (CAS-61-73-4 WC) is an official document issued by a regulatory agency to a CAS-61-73-4 manufacturer, verifying that the manufacturing facility of a CAS-61-73-4 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-61-73-4 APIs or CAS-61-73-4 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-61-73-4 WC (written confirmation) as part of the regulatory process.

    click here to find a list of CAS-61-73-4 suppliers with Written Confirmation (WC) on PharmaCompass.

    CAS-61-73-4 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 CAS-61-73-4 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for CAS-61-73-4 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 CAS-61-73-4 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 CAS-61-73-4 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-61-73-4 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of CAS-61-73-4 suppliers with NDC on PharmaCompass.

    CAS-61-73-4 GMP

    CAS-61-73-4 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 CAS-61-73-4 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 CAS-61-73-4 GMP manufacturer or CAS-61-73-4 GMP API supplier for your needs.

    CAS-61-73-4 CoA

    A CAS-61-73-4 CoA (Certificate of Analysis) is a formal document that attests to CAS-61-73-4's compliance with CAS-61-73-4 specifications and serves as a tool for batch-level quality control.

    CAS-61-73-4 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-61-73-4 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.

    CAS-61-73-4 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-61-73-4 EP), CAS-61-73-4 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-61-73-4 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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