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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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    • EDQM
    • WHO-GMP

    Virtual BoothAxplora- The partner of choice for complex APIs.

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-12-26

    Pay. Date : 2023-09-26

    DMF Number : 32900

    Submission : 2023-09-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-129 - Rev 00

    Issue Date : 2024-09-27

    Type : Chemical

    Substance Number : 1132

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-03-18

    Valid Till : 2025-05-28

    Written Confirmation Number : WC-0019

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 12598-9541

    Start Marketing Date : 2018-01-08

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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    Available Reg Filing : EU
    AUDIT
    Axplora CB

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    02

    ChemWerth Inc

    U.S.A

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

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    CPhI WW Frankfurt
    Booth #12.1F43
    • fda
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-06-28

    Pay. Date : 2022-05-10

    DMF Number : 36603

    Submission : 2022-06-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Biophore India Pharmaceuticals Pvt...

    India

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

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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Biophore

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    04

    Jai Radhe Sales

    India

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

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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Jai Radhe Sales

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    05

    HRV Global Life Sciences

    India

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

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    CPHI Middle east
    Attending
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    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    HRV Global Life Sciences

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    06

    Macsen Labs

    India

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

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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

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    Flag India
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    Digital Content Digital Content
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-10-18

    Pay. Date : 2023-08-28

    DMF Number : 35095

    Submission : 2020-08-17

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-03-28

    Valid Till : 2025-02-17

    Written Confirmation Number : WC-0438

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 73379-101

    Start Marketing Date : 2020-11-25

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Macsen Company Banner

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    07

    Macsen Labs

    India

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

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35482

    Submission : 2020-12-22

    Status : Active

    Type : IV

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

    NDC Package Code : 73379-101

    Start Marketing Date : 2020-11-25

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Macsen Company Banner

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    08

    Sichuan Qingmu Pharmaceutical

    China

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

    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Sichuan Qingmu Pharmaceutical

    China

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

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-05-01

    Pay. Date : 2024-04-19

    DMF Number : 39341

    Submission : 2024-04-15

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Provepharm Life Solutions

    France

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

    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Provepharm Life Solutions

    France

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

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26735

    Submission : 2013-01-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Mikrochem

    Slovakia

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

    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Mikrochem

    Slovakia

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

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-02-23

    Pay. Date : 2023-02-21

    DMF Number : 31694

    Submission : 2017-07-05

    Status : Active

    Type : II

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

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    01

    Pharmazell Gmbh

    Germany
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAxplora- The partner of choice for complex APIs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-12-26

    Pay. Date : 2023-09-26

    DMF Number : 32900

    Submission : 2023-09-21

    Status : Active

    Type : II

    Axplora CB

    Portfolio PDF

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    02

    Chemwerth Inc

    U.S.A
    arrow
    CPhI WW Frankfurt
    Booth #12.1F43
    • fda
    • EDQM
    • WHO-GMP

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

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-06-28

    Pay. Date : 2022-05-10

    DMF Number : 36603

    Submission : 2022-06-01

    Status : Active

    Type : II

    Chemwerth Compnay Banner

    Portfolio PDF

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    03

    Macsen Drugs

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35482

    Submission : 2020-12-22

    Status : Active

    Type : IV

    Macsen Company Banner

    Portfolio PDF

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    04

    Macsen Drugs

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-18

    Pay. Date : 2023-08-28

    DMF Number : 35095

    Submission : 2020-08-17

    Status : Active

    Type : II

    Macsen Company Banner

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    05

    Chemcon Gmbh

    Germany

    USDMF

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    Antibody Engineering
    Not Confirmed

    05

    Chemcon Gmbh

    Germany
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-10-25

    Pay. Date : 2022-07-01

    DMF Number : 36353

    Submission : 2022-07-14

    Status : Active

    Type : II

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    06

    Icrom Srl

    Italy

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    06

    Icrom Srl

    Italy
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-01-25

    Pay. Date : 2021-12-16

    DMF Number : 36307

    Submission : 2021-12-02

    Status : Active

    Type : II

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    07

    Antibody Engineering
    Not Confirmed

    07

    Iso Tex Diagnostics Inc

    U.S.A
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17684

    Submission : 2004-09-09

    Status : Inactive

    Type : II

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    08

    Antibody Engineering
    Not Confirmed

    08

    Luitpold Pharmaceuticals Inc

    U.S.A
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15237

    Submission : 2000-12-28

    Status : Inactive

    Type : II

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    09

    Mikrochem Spol Sro

    Slovakia

    USDMF

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    Antibody Engineering
    Not Confirmed

    09

    Mikrochem Spol Sro

    Slovakia
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-02-23

    Pay. Date : 2023-02-21

    DMF Number : 31694

    Submission : 2017-07-05

    Status : Active

    Type : II

    blank

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    Website

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    10

    Provepharm Sas

    France

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    10

    Provepharm Sas

    France
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26735

    Submission : 2013-01-09

    Status : Active

    Type : II

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    Listed Suppliers

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    01

    Axplora

    Germany
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAxplora- The partner of choice for complex APIs.

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    Methylene Blue

    About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
    Axplora CB

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    02

    ChemWerth Inc

    U.S.A
    arrow
    CPhI WW Frankfurt
    Booth #12.1F43
    • fda
    • EDQM
    • WHO-GMP

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

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    Methylene Blue

    About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

    Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
    Chemwerth Compnay Banner

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    03

    Biophore India Pharmaceuticals Pvt ...

    India
    arrow
    iPHEX India
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Methylene Blue

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

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    04

    Jai Radhe Sales

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Methylene Blue

    About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

    Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
    Jai Radhe Sales

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    05

    HRV Global Life Sciences

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Methylene Blue

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    06

    Macsen Labs

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

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    Flag India
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    Methylene Blue

    About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...

    Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our comprehensive offerings extend to Contract Research & Custom Synthesis. With a legacy of over seven decades, Macsen combines tradition with innovation to meet the evolving needs of the chemical and pharmaceutical sectors. Our commitment to quality is evident in every aspect of our operations, from state-of-the-art manufacturing facilities to advanced analytical capabilities.
    Macsen Company Banner

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    07

    Bioindustria L.I.M. Spa

    Italy
    Antibody Engineering
    Not Confirmed
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    Bioindustria L.I.M. Spa

    Italy
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    Antibody Engineering
    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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    Methylene Blue

    About the Company : Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in: large and small volume injectables with termin...

    Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in: large and small volume injectables with terminal sterilization or with aseptic process, lyophilised dosage forms, syrups, drops, tablets, capsules.
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    08

    Dishman Carbogen Amcis

    India
    Antibody Engineering
    Not Confirmed
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    Dishman Carbogen Amcis

    India
    arrow
    Antibody Engineering
    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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    Methylene Blue

    About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

    We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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    09

    Hetero Drugs

    India
    Antibody Engineering
    Not Confirmed
    arrow

    Hetero Drugs

    India
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    Antibody Engineering
    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.
    Post an Enquiry Post an Enquiry
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    Methylene Blue

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    10

    Icrom

    Italy
    Antibody Engineering
    Not Confirmed
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    Icrom

    Italy
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    Antibody Engineering
    Not Confirmed
    • fda
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    Methylene Blue

    About the Company : ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. ICROM is the partner of choice for pharmaceu...

    ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. ICROM is the partner of choice for pharmaceutical outsourcing. Since 1969, ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. Thanks to the extensive experience and strong know-how, ICROM is the ideal partner for designing and tailoring projects upon customers’ needs.
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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 PVT. LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"M\/S.","customerCountry":"UNITED STATES","quantity":"24.95","actualQuantity":"24.948","unit":"KGS","unitRateFc":"2000","totalValueFC":"48780.2","currency":"USD","unitRateINR":149029.98236331571,"date":"30-Mar-2022","totalValueINR":"3718000","totalValueInUsd":"48780.2","indian_port":"HYDERABAD AIR","hs_no":"29239000","bill_no":"9346451","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"425\/3RT, D.NO.7-1-621\/328,,SANJEEV AREDDY NAGAR,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685125800,"product":"NON HAZARDOUS ACTIVE PHARMACEUTICAL INGREDIENT METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328,,SANJEEV AREDDY NAGAR,","city":"HYDERABAD,TELANGANA","supplier":"AZICO BIOPHORE INDIA PVT. LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK JOHN F K","customer":"TO THE ORDER","customerCountry":"UNITED STATES","quantity":"16.31","actualQuantity":"16.31","unit":"KGS","unitRateFc":"2000","totalValueFC":"32132.5","currency":"USD","unitRateINR":162109.13549969345,"date":"27-May-2023","totalValueINR":"2644000","totalValueInUsd":"32132.5","indian_port":"HYDERABAD AIR","hs_no":"29239000","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"425\/3RT, D.NO.7-1-621\/328,,SANJEEV AREDDY NAGAR,, HYDERABAD,TELANGANA","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 PVT. LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","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":"Q2","strtotime":1714761000,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PVT. LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","customerCountry":"UNITED STATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"2000","totalValueFC":"49246.5","currency":"USD","unitRateINR":164196.07999999999,"date":"04-May-2024","totalValueINR":"4104902","totalValueInUsd":"49246.5","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"9619796","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":"Q3","strtotime":1723401000,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"AZICO BIOPHORE INDIA PVT. LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","customerCountry":"UNITED STATES","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2000","totalValueFC":"19566.7","currency":"USD","unitRateINR":164123,"date":"12-Aug-2024","totalValueINR":"1641230","totalValueInUsd":"19566.7","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"3143982","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":""}]
    30-Mar-2022
    12-Aug-2024
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    Drugs in Development

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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

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

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 26, 2024

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    Nexus Pharmaceuticals

    U.S.A
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    Lead Product(s) : Methylene Blue

    Therapeutic Area : Hematology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    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.

    Brand Name : Methylene Blue Injection, USP

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 26, 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: Small molecule

    Sponsor: Healthcare's Memorial Health University Medical Center

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 08, 2022

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    Ondine Biomedical

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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 : Not Applicable

    Deal Type : Not Applicable

    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...

    Brand Name : PACT

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    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

    Therapeutic Area: Hematology Brand Name: ProvayBlue

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Provepharm Life Solutions

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 30, 2022

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    American Regent

    U.S.A
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    Not Confirmed

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

    Therapeutic Area : Hematology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Provepharm Life Solutions

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    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.

    Brand Name : ProvayBlue

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 30, 2022

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