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Chemistry

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Also known as: 532-03-6, Robaxin, Lumirelax, Metocarbamol, Parabaxin, Delaxin
Molecular Formula
C11H15NO5
Molecular Weight
241.24  g/mol
InChI Key
GNXFOGHNGIVQEH-UHFFFAOYSA-N
FDA UNII
125OD7737X

Methocarbamol
A centrally acting muscle relaxant whose mode of action has not been established. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1206)
Methocarbamol is a Muscle Relaxant. The physiologic effect of methocarbamol is by means of Centrally-mediated Muscle Relaxation.
1 2D Structure

Methocarbamol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-hydroxy-3-(2-methoxyphenoxy)propyl] carbamate
2.1.2 InChI
InChI=1S/C11H15NO5/c1-15-9-4-2-3-5-10(9)16-6-8(13)7-17-11(12)14/h2-5,8,13H,6-7H2,1H3,(H2,12,14)
2.1.3 InChI Key
GNXFOGHNGIVQEH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC1=CC=CC=C1OCC(COC(=O)N)O
2.2 Other Identifiers
2.2.1 UNII
125OD7737X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Carbamate, Guaiphenesin

2. Guaiphenesin Carbamate

3. Lumirelax

4. Ortoton

5. Parabaxin

6. Robaxin

2.3.2 Depositor-Supplied Synonyms

1. 532-03-6

2. Robaxin

3. Lumirelax

4. Metocarbamol

5. Parabaxin

6. Delaxin

7. Perilax

8. Metocarbamolo

9. Etroflex

10. Methocal

11. Metofenia

12. Miolaxene

13. Miorilas

14. Myolaxene

15. Neuraxin

16. Reflexyn

17. Relestrid

18. Romethocarb

19. Surquetil

20. Tresortil

21. Avetil

22. Miowas

23. Robinax

24. Metofenina

25. Forbaxin

26. Guaiacol Glyceryl Ether Carbamate

27. Guaiphenesine Carbamate

28. 2-hydroxy-3-(2-methoxyphenoxy)propyl Carbamate

29. Glycerylguaiacolate Carbamate

30. Glycerylguajacol-carbamat

31. Ahr 85

32. Methocarbamolum

33. Robaxan

34. Robaxine

35. Robaxon

36. Guiacol-gliceriletere Monocarbammato

37. [2-hydroxy-3-(2-methoxyphenoxy)propyl] Carbamate

38. 1,2-propanediol, 3-(2-methoxyphenoxy)-, 1-carbamate

39. 3-(o-methoxyphenoxy)-2-hydroxypropyl Carbamate

40. 3-(o-methoxyphenoxy)-1,2-propanediol 1-carbamate

41. 3-(2-methoxyphenoxy)-1-glyceryl Carbamate

42. Nsc 170960

43. 2-hydroxy-3-(o-methoxyphenoxy)propyl 1-carbamate

44. Methocarbamol (robaxin)

45. Nsc-170960

46. Guaiphenesin Carbamate

47. 1,2-propanediol, 3-(o-methoxyphenoxy)-, 1-carbamate

48. Mls000028610

49. Carbamic Acid, 2-hydroxy-3-(o-methoxyphenoxy)propyl Ester

50. Chebi:77498

51. 125od7737x

52. Robamol

53. Smr000058719

54. Traumacut

55. Dsstox_cid_3286

56. Dsstox_rid_76958

57. Dsstox_gsid_23286

58. Methyocarbamol

59. Metocarbamolo [dcit]

60. Robaxisol

61. Robaxin-750

62. Metocarbamol [inn-spanish]

63. Methocarbamolum [inn-latin]

64. Hsdb 3122

65. Sr-01000000240

66. Einecs 208-524-3

67. 2-hydroxy-3-{[2-(methyloxy)phenyl]oxy}propyl Carbamate

68. Brn 1884446

69. Methacarbamol

70. Unii-125od7737x

71. Ncgc00016492-01

72. Methocarbamol,(s)

73. Cas-532-03-6

74. Methocarbamol [usp:inn:ban:jan]

75. Prestwick_614

76. Delaxin (tn)

77. Robaxin (tn)

78. Mfcd00057662

79. Robaxisol (salt/mix)

80. Spectrum_000997

81. Opera_id_1471

82. Prestwick0_000184

83. Prestwick1_000184

84. Prestwick2_000184

85. Prestwick3_000184

86. Spectrum2_001272

87. Spectrum3_000496

88. Spectrum4_000049

89. Spectrum5_000956

90. Methocarbamol [mi]

91. 2-hydroxy-3-(o-methoxyphenoxy)propyl Carbamate

92. Methocarbamol [inn]

93. Methocarbamol [jan]

94. Methocarbamol [hsdb]

95. Schembl34365

96. Bspbio_000107

97. Bspbio_001991

98. Kbiogr_000517

99. Kbioss_001477

100. Methocarbamol [vandf]

101. 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate

102. Mls001148605

103. Divk1c_000434

104. Methocarbamol [mart.]

105. Spectrum1500397

106. Wln: Zvo1yq1or Bo1

107. Spbio_001264

108. Spbio_002028

109. Methocarbamol [usp-rs]

110. Methocarbamol [who-dd]

111. Bpbio1_000119

112. Gtpl6829

113. Methocarbamol (jan/usp/inn)

114. (+-)-3-(o-methoxyphenoxy)-1,2-propanediol 1-carbamate

115. Chembl1201117

116. Dtxsid6023286

117. Hms501f16

118. Kbio1_000434

119. Kbio2_001477

120. Kbio2_004045

121. Kbio2_006613

122. Kbio3_001491

123. Ninds_000434

124. Hms1568f09

125. Hms1920l19

126. Hms2091d14

127. Hms2095f09

128. Hms2233g18

129. Hms3259m17

130. Hms3369b17

131. Hms3655o06

132. Hms3712f09

133. Methocarbamol [green Book]

134. Pharmakon1600-01500397

135. Methocarbamol [orange Book]

136. Bcp13801

137. Hy-b0262

138. Tox21_110454

139. Ccg-39655

140. Methocarbamol [usp Monograph]

141. Nsc170960

142. Nsc757112

143. S1736

144. Akos015960743

145. Tox21_110454_1

146. Db00423

147. Nc00509

148. Nsc-757112

149. Idi1_000434

150. Robaxisal Component Methocarbamol

151. Ncgc00018257-02

152. Ncgc00018257-03

153. Ncgc00018257-04

154. Ncgc00018257-07

155. Ncgc00018257-08

156. Ncgc00018257-16

157. Ncgc00089805-02

158. Ncgc00089805-03

159. 1, 3-(o-methoxyphenoxy)-, 1-carbamate

160. Ac-12037

161. As-11691

162. 1, 3-(2-methoxyphenoxy)-, 1-carbamate

163. Methocarbamol Component Of Robaxisal

164. Sbi-0051442.p003

165. 3-o-(2-methoxyphenyl)-1-glyceryl Carbamate

166. Ab00052040

167. Ft-0628302

168. Ft-0671053

169. M2254

170. Sw196781-3

171. D00402

172. D70323

173. Ab00052040-15

174. Ab00052040_16

175. Ab00052040_17

176. 2-hydroxy-3-(2-methoxyphenoxy)propyl Carbamate #

177. A829442

178. Q411456

179. Sr-01000000240-2

180. Sr-01000000240-3

181. (rs)-2-hydroxy-3-(2-methoxyphenoxy)propyl Carbamate

182. Brd-a31521121-001-05-8

183. Guaiacol Glyceryl Ether Carbamate, Analytical Standard

184. (+/-)-3-( O-methoxyphenoxy)-1,2-propanediol 1-carbamate

185. Carbamic Acid 2-hydroxy-3-(2-methoxyphenoxy)propyl Ester

186. Carbamic Acid [2-hydroxy-3-(2-methoxy-phenoxy)-propyl] Ester

187. (+/-)-3-(o-methoxyphenoxy)-1,2-propanediol 1-carbamate

188. Methocarbamol, United States Pharmacopeia (usp) Reference Standard

189. 1,2-propanediol, 3-(2-methoxyphenoxy)-, 1-carbamate, (+/-)-

190. Methocarbamol, Pharmaceutical Secondary Standard; Certified Reference Material

191. 3967-43-9

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 241.24 g/mol
Molecular Formula C11H15NO5
XLogP30.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass241.09502258 g/mol
Monoisotopic Mass241.09502258 g/mol
Topological Polar Surface Area91 Ų
Heavy Atom Count17
Formal Charge0
Complexity236
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameMethocarbamol
PubMed HealthMethocarbamol
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug Labelrobaxin/robaxin-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)...
Active IngredientMethocarbamol
Dosage FormTablet
RouteOral
Strength500mg; 750mg
Market StatusPrescription
CompanyHikma Intl Pharms; Vintage Pharms; Hetero Labs Ltd Iii; Sandoz; Prinston; Lannett Holdings; Watson Labs; Austarpharma

2 of 6  
Drug NameRobaxin
PubMed HealthMethocarbamol
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug Labelrobaxin/robaxin-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)...
Active IngredientMethocarbamol
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength500mg; 100mg/ml
Market StatusPrescription
CompanyAuxilium Pharms; Hikma Maple

3 of 6  
Drug NameRobaxin-750
PubMed HealthMethocarbamol (By mouth)
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Active IngredientMethocarbamol
Dosage FormTablet
RouteOral
Strength750mg
Market StatusPrescription
CompanyAuxilium Pharms

4 of 6  
Drug NameMethocarbamol
PubMed HealthMethocarbamol
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug Labelrobaxin/robaxin-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)...
Active IngredientMethocarbamol
Dosage FormTablet
RouteOral
Strength500mg; 750mg
Market StatusPrescription
CompanyHikma Intl Pharms; Vintage Pharms; Hetero Labs Ltd Iii; Sandoz; Prinston; Lannett Holdings; Watson Labs; Austarpharma

5 of 6  
Drug NameRobaxin
PubMed HealthMethocarbamol
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug Labelrobaxin/robaxin-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)...
Active IngredientMethocarbamol
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength500mg; 100mg/ml
Market StatusPrescription
CompanyAuxilium Pharms; Hikma Maple

6 of 6  
Drug NameRobaxin-750
PubMed HealthMethocarbamol (By mouth)
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Active IngredientMethocarbamol
Dosage FormTablet
RouteOral
Strength750mg
Market StatusPrescription
CompanyAuxilium Pharms

4.2 Therapeutic Uses

Muscle Relaxants, Central

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


Skeletal muscle relaxants are indicated as adjunts to other measures, such as rest and physical therapy, for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. /Included in US product label/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2625


Methcarbamol is also FDA-approved for control of the neuromuscular manifestations of tetanus. However it has largely been replaced in the treatment of tetanus by diazepam, or, in severe cases a neuromuscular blocking agent such as pancuronium. Such therapy is used as an adjunct to other measures, such as debridement, tetanus antitoxin, penicillin, tracheotomy, fluid and electrolyte replacement, and supportive treatment.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2625


VET: In dogs, cats, and horses, methocarbamol is indicated as adjunct therapy of acute inflammatory and traumatic conditions of skeletal muscle and to reduce muscle spasms.

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2017


For more Therapeutic Uses (Complete) data for METHOCARBAMOL (6 total), please visit the HSDB record page.


4.3 Drug Warning

The most frequent adverse effects of methocarbamol are drowsiness, dizziness, and lightheadedness. Blurred vision, headache, fever, and nausea may occur after oral, IM, or IV administration of the drug. Anorexia has been reported after oral administration. Adynamic ileus occurred in one patient who received a total of 10 g of methocarbamol orally. Metallic taste, GI upset, nystagmus, diplopia, flushing, vertigo, mild muscular incoordination, syncope, hypotension, and bradycardia have occurred in patients receiving the drug IM or IV.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


Allergic reactions such as urticaria, pruritus, rash, skin eruptions, and conjunctivitis with nasal congestion may occur in patients receiving methocarbamol. Anaphylactic reactions have occurred following IM or IV administration of the drug. Although most patients with methocarbamol-induced syncope recover with supportive treatment, epinephrine, corticosteroids, and/or antihistamines have been used to increase the rate of recovery in some of these patients.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


When methocarbamol is administered IV, thrombophlebitis, sloughing, and pain at the injection site may result from extravasation. IM injection of the drug may also cause local irritation. IV injection of methocarbamol may cause a small amount of hemolysis and increased hemoglobin and red blood cells in the urine. Leukopenia may occur rarely.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


Parenteral dosage forms should be used with caution in patients with epilepsy.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2629


For more Drug Warnings (Complete) data for METHOCARBAMOL (14 total), please visit the HSDB record page.


4.4 Drug Indication

Methocarbamol tablets and intramuscular injections are indicated in the United States as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. Oral methocarbamol in America may be given up to 1500mg 4 times daily for 2-3 days. In Canada, methocarbamol containing oral formulations are sold over the counter for pain associated with muscle spasm. However, if these combination formulations include codeine, they are prescription only.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Methacarbamol is a skeletal muscle relaxant with an unknown mechanism of action. Methacarbamol has been shown to block spinal polysynaptic reflexes, decrease nerve transmission in spinal and supraspinal polysynaptic pathways, and prolong the refractory period of muscle cells. Methocarbamol does not act as a local anesthetic upon injection. In animal studies, methocarbamol also prevents convulsions after electric shock.


5.2 MeSH Pharmacological Classification

Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
METHOCARBAMOL
5.3.2 FDA UNII
125OD7737X
5.3.3 Pharmacological Classes
Muscle Relaxant [EPC]; Centrally-mediated Muscle Relaxation [PE]
5.4 ATC Code

M - Musculo-skeletal system

M03 - Muscle relaxants

M03B - Muscle relaxants, centrally acting agents

M03BA - Carbamic acid esters

M03BA03 - Methocarbamol


5.5 Absorption, Distribution and Excretion

Absorption

The time to maximum concentration is 1.1 hours for both healthy patients and those on hemodialysis. The maximum plasma concentration is 21.3mg/L for healthy patients and 28.7mg/L in hemodialysis patients. The area under the curve for healthy patients is 52.5mg/L\*hr and 87.1mg/L*hr in hemodialysis patients. AUC% based on terminal elimination half life is 2% for healthy patients and 4% for hemodialysis patients. Older studies report maximum plasma concentrations in 0.5 hours.


Route of Elimination

In humans the majority of the dose is eliminated in the urine. In dogs, 88.85% of the dose is eliminated in urine and 2.14% in the feces. In rats, 84.5-92.5% of the dose is eliminated in the urine and 0-13.3% is eliminated in the feces.


Volume of Distribution

Volume of distribution data in humans is scarce. In horses, the volume of distribution is 515-942mL/kg at steady state or 724-1130mL/kg.


Clearance

0.2-0.8L/h/kg.


Methocarbamol is rapidly and almost completely absorbed from the GI tract. Blood or serum concentrations of methocarbamol required for sedative, skeletal muscle relaxant, or toxic effects are not known.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


Following oral administration of a single dose of methocarbamol, peak blood or serum concentrations of the drug appear to be attained in approximately 1-2 hours; the onset of action is usually within 30 minutes. Data from an unpublished study indicate that peak blood concentrations (measured as total carbamates and expressed in terms of methocarbamol) average 16.5 mcg/mL following a single 2-g oral dose, while data from a published study (using an assay relatively specific for methocarbamol) indicate that peak serum concentrations average 29.8 mcg/mL following the same dose. Data from the unpublished study also indicate that after IV administration of 1 g of methocarbamol at a rate of 300 mg/minute, blood concentrations of 19 mcg/mL are attained immediately and that the onset of action is almost immediate.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


In dogs, methocarbamol is widely distributed, with highest concentrations attained in the kidney and liver; lower concentrations are attained in the lungs, brain, and spleen, and low concentrations are attained in heart and skeletal muscle.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


The drug and/or its metabolites cross the placenta in dogs. It is not known if methocarbamol is distributed into milk in humans.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


For more Absorption, Distribution and Excretion (Complete) data for METHOCARBAMOL (8 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Methocarbamol is metabolized in the liver by demethylation to 3-(2-hydroxyphenoxy)-1,2-propanediol-1-carbamate or hydroxylation to 3-(4-hydroxy-2-methoxyphenoxy)-1,2-propanediol-1-carbamate. Methocarbamol and its metabolites are conjugated through glucuronidation or sulfation.


Methocarbamol is extensively metabolized, presumably in the liver, by dealkylation and hydroxylation.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


Based on limited data, about 10-15% of a single oral dose is excreted in urine as unchanged drug, about 40-50% as the glucuronide and sulfate conjugates of 3-(2-hydroxyphenoxy)-1,2-propanediol-1-carbamate and 3-(4-hydroxy-2-methoxyphenoxy)-1,2-propanediol-1-carbamate, and the remainder as unidentified metabolites.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


In dogs, rats and in man, methocarbamol gave p-hydroxymethocarbamol and o-demethylation product. All three substances were excreted in urine as glucuronic acid and ester sulfate conjugates.

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 206


Permethylation and g.l.c.-mass spectrometric analysis of bile from an isolated rat liver perfusion to which methocarmol was added showed seven components not present in control bile: methocarbamol, glucuronides of methocarbamol and desmethyl-methocarbamol, and four glucuronides of hydroxylated methocarbamol metabolites. 2. An interesting rearrangement of a methyl group has been found in the mass spectrum of 3-(2-methoxyphenyloxy)-1,2-dimethoxypropane, the permethylation product from methocarbamol.

PMID:1166662 Thompson RM, Gerber N et al; Xenobiotica 5 (3): 145-53 (1975)


5.7 Biological Half-Life

The elimination half life is 1.14 hours in healthy subjects and 1.24 hours in subjects with renal insufficiency. Older studies report half lives of 1.6-2.15 hours.


Methocarbamol has a serum half-life of 0.9-1.8 hours.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007.


... Pharmacokinetics of methocarbamol were studied in eight healthy, adult horses after intravenous (iv) and oral administration of large dosages. ... Plasma methocarbamol concentration declined very rapidly during the initial or rapid disposition phase after iv administration; the terminal elimination half-life ranged from 59 to 90 mins. ...

PMID:9109959 Muir W, Sams R et al; Equine Vet J Suppl (11): 41-4 (1992)


/Investigators/ determined plasma methocarbamol concentrations over 24 hr following a 1.5 g methocarbamol dose (off-dialysis day) to 8 chronic hemodialysis patients and compared these results to those from 17 healthy male volunteers. The harmonic mean elimination half-life was similar between the two groups, 1.24 and 1.14 hr, respectively. ...

PMID:2253675 Sica D, Comstock T et al; Eur J Clin Pharmacol 39 (2): 193-4 (1990)


... Pharmacokinetics of methocarbamol were studied in eight healthy, adult horses after intravenous (iv) and oral administration of large dosages. ... Plasma methocarbamol concentration declined very rapidly during the initial or rapid disposition phase after iv administration; the terminal elimination half-life ranged from 59 to 90 mins. ...

PMID:9109959 Muir W, Sams R et al; Equine Vet J Suppl (11): 41-4 (1992)


5.8 Mechanism of Action

The mechanism of action of methocarbamol is thought to be dependant on its central nervous system depressant activity. This action may be mediated through blocking spinal polysynaptic reflexes, decreasing nerve transmission in spinal and supraspinal polysynaptic pathways, and prolonging the refractory period of muscle cells. Methocarbamol has been found to have no effect on contraction of muscle fibres, motor end plates, or nerve fibres.


Precise mechanism of action has not been determined. These agents act in the central nervous system (CNS) rather than directly on skeletal muscle. Several of these medications have been shown to depress polysynaptic reflexes preferentially. The muscle relaxant effects of most of these agents may be related to their CNS depressant (sedative) effects. /Skeletal Muscle Relaxants/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2625


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Synthokem Labs

03

Granules India Limited

India

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

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Granules India

04

Transo-Pharm USA LLC

U.S.A

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

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Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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05

LGM Pharma

U.S.A

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

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Not Confirmed
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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06

DKSH

Switzerland

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

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

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07

Jai Radhe Sales

India

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

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

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Jai Radhe Sales

08

Pharm-RX Chemical

U.S.A

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

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Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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Pharm RX

09

Faran Shimi Pharmaceutical

Iran

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

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Faran Shimi Pharmaceutical

10

HRV Global Life Sciences

India

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

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

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HRV Global Life Sciences
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02-Jan-2021
02-Nov-2024
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DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11011

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DOSAGE - TABLET;ORAL - 750MG **Federal Regist...DOSAGE - TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11011

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ABOUT THIS PAGE

Methocarbamol Manufacturers

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

Methocarbamol Suppliers

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

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

Methocarbamol USDMF

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

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

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

Methocarbamol JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Methocarbamol Drug Master File in Japan (Methocarbamol JDMF) empowers Methocarbamol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Methocarbamol JDMF during the approval evaluation for pharmaceutical products. At the time of Methocarbamol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Methocarbamol suppliers with JDMF on PharmaCompass.

Methocarbamol KDMF

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

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

After submitting a Methocarbamol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Methocarbamol API can apply through the Korea Drug Master File (KDMF).

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

Methocarbamol WC

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

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

Methocarbamol 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 Methocarbamol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Methocarbamol GMP

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

Methocarbamol CoA

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

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

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