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13 Microlex e.U
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3 Novo Excipients
3 Pharmatrans-Sanaq
4 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
22 Roquette
8 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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11 Sigachi Industries
2 The Dow Chemical Company
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Axplora Methylene Blue

Synopsis

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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

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 Formula	C₁₆H₁₈ClN₃S
Molecular Weight	319.9 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	1
Exact Mass	319.0909965 g/mol
Monoisotopic Mass	319.0909965 g/mol
Topological Polar Surface Area	43.9 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	483
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

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.

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

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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Rev. Date : 2023-12-26

Pay. Date : 2023-09-26

DMF Number : 32900

Submission : 2023-09-21

Status : Active

Type : II

02

Chemwerth Inc

U.S.A

VMX

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

METHYLENE BLUE USP

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

03

Macsen Drugs

India

Pharma, Lab & Chemical Expo

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

METHYLENE BLUE USP (COLOUR)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35482

Submission : 2020-12-22

Status : Active

Type : IV

04

Macsen Drugs

India

Pharma, Lab & Chemical Expo

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

METHYLENE BLUE USP

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

05

Chemcon Gmbh

Germany

France

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

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CEP/COS

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EU WC

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NDC API

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Listed Suppliers

01

Axplora

Germany

BIO Partnering at JPM

Not Confirmed

Axplora- The partner of choice for complex APIs.

Contact Supplier

Germany

Virtual Booth

Digital Content

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.

02

ChemWerth Inc

U.S.A

VMX

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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.

03

Biophore India Pharmaceuticals Pvt ...

India

DCAT Week

Attending

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

Contact Supplier

India

Virtual Booth

Digital Content

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.

04

Jai Radhe Sales

India

BIO Partnering at JPM

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

Digital Content

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.

05

HRV Global Life Sciences

India

BIO Partnering at JPM

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

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.

06

Macsen Labs

India

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

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.

07

Bioindustria L.I.M. Spa

Italy

BIO Partnering at JPM

Not Confirmed

08

Dishman Carbogen Amcis

India

BIO Partnering at JPM

Not Confirmed

09

Hetero Drugs

India

BIO Partnering at JPM

Not Confirmed

10

Icrom

Italy

BIO Partnering at JPM

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662921000,"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":"CINCINNATI, OH","customer":"M\/S.","customerCountry":"UNITED STATES","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"2000","totalValueFC":"38694.3","currency":"USD","unitRateINR":155050,"date":"12-Sep-2022","totalValueINR":"3101000","totalValueInUsd":"38694.3","indian_port":"HYDERABAD AIR","hs_no":"29239000","bill_no":"4108807","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":"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":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"METHYLENE BLUE","address":"425\/3RT, D.NO.7-1-621\/328,","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":"19699","currency":"USD","unitRateINR":166236,"date":"02-Nov-2024","totalValueINR":"1662360","totalValueInUsd":"19699","indian_port":"Hyderabad Air","hs_no":"29239000","bill_no":"5330307","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 Import","activeIngredients":"METHYLENE BLUE","year":"2021","qtr":"Q1","strtotime":1614709800,"product":"BENZOYL LEUCO METHYLENE BLUE (BLMB)","address":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,","city":"HYDERABAD, AP.","supplier":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","supplierCountry":"INDIA","foreign_port":"MARSEILLE","customer":"AZICO BIOPHORE INDIA PVT. LTD","customerCountry":"INDIA","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"2000","totalValueFC":"34419.7","currency":"USD","unitRateINR":"147400","date":"03-Mar-2021","totalValueINR":"2505800","totalValueInUsd":"34419.7","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"2990632","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MARSEILLE","supplierAddress":"","customerAddress":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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FDF Dossiers

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FDA Orange Book

01

NEXUS

U.S.A

India

Biotech Showcase

Not Confirmed

05

ZYDUS LIFESCIENCES

India

Biotech Showcase

Not Confirmed

06

ZYDUS LIFESCIENCES

India

Biotech Showcase

Not Confirmed

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Europe

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Canada

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Listed Dossiers

01

Health Biotech

India

Duphat

Not Confirmed

02

Laboratório Gross

Brazil

Duphat

Not Confirmed

03

Verve Human Care Laboratories

India

Duphat

Not Confirmed

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Related Excipient Companies

Upload your portfolio for free, ask us

Excipients by Applications

Click here to find the perfect excipient manufacturers by their capabilities

Fillers, Diluents & Binders

Coating Systems & Additives

Disintegrants & Superdisintegrants

Direct Compression

01

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : MS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-170, Taped Density: 0.80

Ingredient(s) : Starch

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : Advantose FS95

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Fructose

03

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Direct Compression, Disintegrants & Superdisintegrants

Brand Name : Solvostar™

Application : Direct Compression, Disintegrants & Superdisintegrants

Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant and directly compressible excipient in tablets, capsules, suspensions, and pellets.

Pharmacopoeia Ref : IP/BP/EP/USP-NF

Technical Specs : Solvostar 2% to 8%

Ingredient(s) : Sodium Starch Glycolate

04

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

Brand Name : DiCOM-DC® SP204

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

05

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : DiCOM-DC® S-Star

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : DiCOM-DC S-Star (Maize Starch) is used as a filler, binder, and directly compressible co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Maize Starch

06

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

07

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : CS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-175, Tapped Density: 0.85

Ingredient(s) : Calcium Carbonate Excipient

08

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : Microlose™ M60 P60

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

Ingredient(s) : Lactose Monohydrate

09

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

10

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

Only 10 entries up to this point, click to access all

Controlled & Modified Release

01

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Brand Name : DiCOM-DC® SR300

Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : EthylCellulose

02

Nanjing Well Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels

Grade : Parenteral, Topical, Oral

Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polyethylene Glycol 400

Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polyethylene Glycol 400

03

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Controlled & Modified Release

Brand Name : Gellets-P®

Application : Controlled & Modified Release

Excipient Details : Gellets-P are Microcrystalline Cellulose based spheres for the manufacturing of pellets and modified release products.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Microcrystalline Cellulose

Excipients Web Link

India

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

Thickeners and Stabilizers

Granulation

Chewable & Orodispersible Aids

01

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : Advantose FS95

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Fructose

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Advantol 300

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chewable or soft melt oral dosage forms & enables rapid product development.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Taste Masking

Brand Name : Pharmasperse 416

Application : Chewable & Orodispersible Aids, Taste Masking

Excipient Details : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

05

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Compressol SM

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

06

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Category : API Stability Enhancers, Chewable & Orodispersible Aids, Fillers, Diluents & Binders

Brand Name : Mannogem XL Mannitol

Application : API Stability Enhancers, Chewable & Orodispersible Aids, Fillers, Diluents & Binders

Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

07

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Brand Name : Mannogem EZ Spray-Dried

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Excipient Details : Mannogem EZ Spray-Dried, a mannitol product, dissolves rapidly and can increase the rate of tablet disintegration, drug dissolution & drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

08

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Brand Name : Mannogem Granular

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders

Excipient Details : Mannogem Granular (mannitol) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

09

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : MS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-170, Taped Density: 0.80

Ingredient(s) : Starch

10

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Brand Name : CS90

Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking

Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 150-175, Tapped Density: 0.85

Ingredient(s) : Calcium Carbonate Excipient

Only 10 entries up to this point, click to access all

Lubricants & Glidants

Taste Masking

Topical

Co-Processed Excipients

Film Formers & Plasticizers

Solubilizers

Empty Capsules

Parenteral

API Stability Enhancers

Emulsifying Agents

Coloring Agents

01

DKSH

Switzerland

Pharma, Lab & Chemical Expo

Not Confirmed

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01FG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.

Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

02

DKSH

Switzerland

Pharma, Lab & Chemical Expo

Not Confirmed

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01PhG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.

Pharmacopoeia Ref : N/A

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

03

Seppic

France

Pharma, Lab & Chemical Expo

Not Confirmed

04

Seppic

France

Pharma, Lab & Chemical Expo

Not Confirmed

Rheology Modifiers

Vegetarian Capsules

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Global Sales Information

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Finished Drug Prices

01

Brand Name : Methylene Blue

Country

Pharma, Lab & Chemical Expo

Not Confirmed

Not Confirmed

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Annual Reports

01 Brand Name : Lumeblue

Methylene Blue MMX

Pharma, Lab & Chemical Expo

Not Confirmed

02 Brand Name : Lumeblue

Methylene Blue MMX

Pharma, Lab & Chemical Expo

Not Confirmed

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Market Place

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APIs

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FDF DOSSIERS

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INTERMEDIATES

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Patents & EXCLUSIVITIES

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US Exclusivities

01

PROVEPHARM SAS

METHYLENE BLUE

Duphat

Not Confirmed

02

PROVEPHARM SAS

METHYLENE BLUE

Duphat

Not Confirmed

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ABOUT THIS PAGE

Methylene Blue Manufacturers

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

Methylene Blue Suppliers

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

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

Methylene Blue USDMF

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

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

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

Methylene Blue CEP

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

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

Methylene Blue WC

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

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

Methylene Blue 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 Methylene Blue as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Methylene Blue GMP

Methylene Blue 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 Methylene Blue 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 Methylene Blue GMP manufacturer or Methylene Blue GMP API supplier for your needs.

Methylene Blue CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

18 API Suppliers

11 USDMF

3 CEP/COS

2 EU WC

14 NDC API

10 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers

6 FDA Orange Book

7 Europe

5 Canada

3 Listed Dossiers

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1 Rochem International Inc

16 SPI Pharma

2 Seqens

7 DKSH

4 Faran Shimi Pharmaceutical

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12 Gangwal Healthcare

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1 Pfanstiehl

4 ACG Worldwide

4 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

20 BASF

11 Corel Pharma Chem

4 DFE Pharma

2 Finar

10 Gangwal Chemicals

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5 Ingredion Pharma Solutions

19 Kerry

3 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

13 Microlex e.U

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

22 Roquette

8 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders

53 Coating Systems & Additives

40 Disintegrants & Superdisintegrants

39 Direct Compression

29 Controlled & Modified Release

28 Thickeners and Stabilizers

21 Granulation

17 Chewable & Orodispersible Aids

17 Lubricants & Glidants

15 Taste Masking

15 Topical

15 Co-Processed Excipients

13 Film Formers & Plasticizers

10 Solubilizers

9 Empty Capsules