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Metaxalone

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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5 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
19 Roquette
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1 Shanghai Welltone Material Technology Co., Ltd
10 Sigachi Industries
3 The Dow Chemical Company
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Synopsis

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Chemistry

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Also known as: 1665-48-1, Skelaxin, Zorane, Methaxalonum, Metaxalon, Methoxolone

Molecular Formula

C₁₂H₁₅NO₃

Molecular Weight

221.25 g/mol

InChI Key

IMWZZHHPURKASS-UHFFFAOYSA-N

FDA UNII

1NMA9J598Y

Metaxalone is an oxazolidinone with centrally-acting skeletal muscle relaxant properties. Although the exact mechanism through which metaxalone exerts its effect is largely unknown, it might be due to general central nervous system (CNS) depression. Metaxalone has no direct effect on the contractile mechanisms of striated muscle, the motor end plate, or the nerve fiber.

The physiologic effect of metaxalone is by means of Centrally-mediated Muscle Relaxation.

1 2D Structure

Metaxalone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one

2.1.2 InChI

InChI=1S/C12H15NO3/c1-8-3-9(2)5-10(4-8)15-7-11-6-13-12(14)16-11/h3-5,11H,6-7H2,1-2H3,(H,13,14)

2.1.3 InChI Key

IMWZZHHPURKASS-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CC(=CC(=C1)OCC2CNC(=O)O2)C

2.2 Other Identifiers

2.2.1 UNII

1NMA9J598Y

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Ahr 438

2. Skelaxin

2.3.2 Depositor-Supplied Synonyms

1. 1665-48-1

2. Skelaxin

3. Zorane

4. Methaxalonum

5. Metaxalon

6. Methoxolone

7. 5-((3,5-dimethylphenoxy)methyl)oxazolidin-2-one

8. Metazalone

9. Metazolone

10. Metaxolone

11. Ahr-438

12. Metaxalonum [latin]

13. Metassalone [dcit]

14. 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one

15. 2-oxazolidinone, 5-[(3,5-dimethylphenoxy)methyl]-

16. Ahr 438

17. Metaxalonum [inn-latin]

18. Metaxalona [inn-spanish]

19. Nsc 170959

20. 5-(3,5-xyloloxymethyl)oxazolidin-2-one

21. Cl 39,148

22. Flexura

23. 5-((3,5-xylyloxy)methyl)-2-oxazolidinone

24. 5-[(3,5-xylyloxy)methyl]-2-oxazolidinone

25. 2-oxazolidinone, 5-((3,5-xylyloxy)methyl)-

26. 5-((3,5-dimethylphenoxy)methyl)-2-oxazolidinone

27. Mfcd00867700

28. Nsc170959

29. 5-[(3,5-dimethylphenoxy)methyl]oxazolidin-2-one

30. Nsc-170959

31. 2-oxazolidinone, 5-((3,5-dimethylphenoxy)methyl)-

32. 5-(3,5-dimethylphenoxymethyl)-1,3-oxazolidin-2-one

33. Mls003106749

34. 1nma9j598y

35. Chebi:6797

36. 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone

37. Ncgc00095116-01

38. Dsstox_cid_3269

39. 2-oxazolidinone, 5-[(3,5-xylyloxy)methyl]-

40. Dsstox_rid_76949

41. Dsstox_gsid_23269

42. Metaxalona [spanish]

43. Metassalone

44. Metaxalona

45. Metaxalonum

46. Cas-1665-48-1

47. Metaxalone [usan:inn:ban]

48. Hsdb 3236

49. Sr-05000001978

50. Einecs 216-777-6

51. 5-((3,5-dimethylphenoxy)methyl)-1,3-oxazolidin-2-one

52. Brn 0884592

53. Unii-1nma9j598y

54. .meta.xalone

55. .meta.zalone

56. .meta.zolone

57. .meta.xalon

58. Metaxalone Solution

59. Skelaxin (tn)

60. Spectrum_001741

61. Metaxalone [mi]

62. Specplus_000656

63. Metaxalone (usp/inn)

64. Metaxalone [inn]

65. Spectrum2_000548

66. Spectrum3_001666

67. Spectrum4_000612

68. Spectrum5_001685

69. Metaxalone [hsdb]

70. Metaxalone [usan]

71. Metaxalone [vandf]

72. 5-(3,5-dimethylphenoxymethyl)-2-oxazolidinone

73. Metaxalone [mart.]

74. Metaxalone [usp-rs]

75. Metaxalone [who-dd]

76. Oprea1_438855

77. Schembl34908

78. Bspbio_003451

79. Kbiogr_001164

80. Kbioss_002221

81. Divk1c_006752

82. Spectrum1504229

83. Spbio_000595

84. Ahr438

85. Gtpl7609

86. Chembl1079604

87. Dtxsid3023269

88. Metaxalone [orange Book]

89. Metaxalone, >=98% (hplc)

90. Kbio1_001696

91. Kbio2_002221

92. Kbio2_004789

93. Kbio2_007357

94. Kbio3_002671

95. Hms1922h07

96. Hms2093c22

97. Metaxalone [usp Monograph]

98. Pharmakon1600-01504229

99. Bcp28377

100. Hy-b0678

101. Tox21_111428

102. Wln: T5mvotj D1or C1 E1

103. 2-oxazolidinone,5-xylyloxy)methyl]-

104. Ccg-39592

105. Nsc758703

106. S3730

107. Stl450994

108. Stl451511

109. Akos009035315

110. Tox21_111428_1

111. Db00660

112. Fs-3218

113. Nsc-758703

114. Ncgc00095116-02

115. Ncgc00095116-03

116. Ncgc00095116-05

117. Smr001821638

118. Sy052772

119. Sbi-0052859.p002

120. 2-oxazolidinone,5-dimethylphenoxy)methyl]-

121. Db-043656

122. Am20060525

123. Ft-0603568

124. M2578

125. 5-(3,5-dimethylphenoxy)methyl-2-oxazolidinone

126. C07934

127. D00773

128. Ab00053284_04

129. 665m481

130. A810747

131. J-010295

132. Q6823309

133. Sr-05000001978-1

134. Sr-05000001978-3

135. Brd-a94709349-001-02-6

136. Brd-a94709349-001-03-4

137. 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one #

138. 5-{[(3,5-dimethylphenyl)oxy]methyl}-1,3-oxazolidin-2-one

139. 5-[(3,5-dimethylphenoxy)methyl]-4,5-dihydro-1,3-oxazol-2-ol

140. Metaxalone, United States Pharmacopeia (usp) Reference Standard

141. Metaxalone Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₁₂H₁₅NO₃
Molecular Weight	221.25 g/mol
XLogP3	2.2
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	221.10519334 g/mol
Monoisotopic Mass	221.10519334 g/mol
Topological Polar Surface Area	47.6 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	247
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Metaxalone
PubMed Health	Metaxalone (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	DESCRIPTION Metaxalone tablets are available as an 800 mg oval, convex pink tablet.Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The...
Active Ingredient	Metaxalone
Dosage Form	Tablet
Route	oral; Oral
Strength	400mg; 800mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; Amneal Pharms; Sandoz

2 of 4
Drug Name	Skelaxin
PubMed Health	Metaxalone (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet.Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structu...
Active Ingredient	Metaxalone
Dosage Form	Tablet
Route	Oral
Strength	800mg
Market Status	Prescription
Company	King Pharms

3 of 4
Drug Name	Metaxalone
PubMed Health	Metaxalone (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	DESCRIPTION Metaxalone tablets are available as an 800 mg oval, convex pink tablet.Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The...
Active Ingredient	Metaxalone
Dosage Form	Tablet
Route	oral; Oral
Strength	400mg; 800mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; Amneal Pharms; Sandoz

4 of 4
Drug Name	Skelaxin
PubMed Health	Metaxalone (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet.Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structu...
Active Ingredient	Metaxalone
Dosage Form	Tablet
Route	Oral
Strength	800mg
Market Status	Prescription
Company	King Pharms

4.2 Therapeutic Uses

Metaxalone is used as an adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. /Included in US product label/

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1394

4.3 Drug Warning

The most frequent adverse effects of metaxalone are drowsiness, dizziness, headache, nervousness or irritability, nausea, vomiting, and GI upset. Other adverse effects include confusion, anorexia, dry mouth, and urinary retention. Exacerbation of tonic-clonic (grand mal) seizures has also been reported.

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1394

Hypersensitivity reactions and rash (with or without pruritus) have occurred in patients receiving metaxalone. Anaphylactoid reactions, leukopenia, hemolytic anemia, and jaundice have occurred rarely. Abnormalities in liver function tests, such as increased serum concentrations of AST (SGOT), ALT (SGPT), alkaline phosphatase, and bilirubin, and increased sulfobromophthalein (BSP) retention and thymol turbidity, have occurred in patients receiving metaxalone. Although a causal relationship to metaxalone has not been established, nephrotoxicity and proteinuria have occurred rarely during treatment with the drug; pyuria and nephrolithiasis have also been reported.

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1394

Safety and efficacy of metaxalone in children 12 years of age or younger have not been established; therefore, the drug should not be administered to children in this age group.

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1394

Patients should be warned that metaxalone may impair ability to perform hazardous activities requiring mental alertness or physical coordination, such as operating machinery or driving a motor vehicle. In addition, patients should be warned that additive CNS depression may occur when the drug is administered concomitantly with other CNS depressants, including alcohol. Metaxalone should be used with caution in geriatric patients and in patients with hepatic or renal impairment. Liver function studies should be performed periodically during metaxalone therapy in patients with preexisting liver damage. The drug is contraindicated in patients with substantially impaired hepatic or renal function, known hypersensitivity to the drug or any ingredient in the formulation, or a history of drug-induced, hemolytic, or other anemias.

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1394

For more Drug Warnings (Complete) data for METAXALONE (8 total), please visit the HSDB record page.

4.4 Drug Indication

For the treatment of painful peripheral musculoskeletal conditions and spasticity from upper motor neuron syndromes.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Metaxalone is a skeletal muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

5.2 MeSH Pharmacological Classification

Neuromuscular Agents

Drugs used for their actions on skeletal muscle. Included are agents that act directly on skeletal muscle, those that alter neuromuscular transmission (NEUROMUSCULAR BLOCKING AGENTS), and drugs that act centrally as skeletal muscle relaxants (MUSCLE RELAXANTS, CENTRAL). Drugs used in the treatment of movement disorders are ANTI-DYSKINESIA AGENTS. (See all compounds classified as Neuromuscular Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

METAXALONE

5.3.2 FDA UNII

1NMA9J598Y

5.3.3 Pharmacological Classes

Centrally-mediated Muscle Relaxation [PE]

5.4 Absorption, Distribution and Excretion

Absorption

The absolute bioavailability of metaxalone from Skelaxin tablets is not known.

Route of Elimination

Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites.

Volume of Distribution

800 L

Clearance

68 +/- 50 L/h [Subjects received 1400mg tablet under fasted conditions]

66 +/- 51 L/h [Subjects received 2400 mg tablets under fasted conditions]

Although plasma protein binding and absolute bioavailability of metaxalone are not known, the apparent volume of distribution (V/F ~ 800 L) and lipophilicity (log P = 2.42) of metaxalone suggest that the drug is extensively distributed in the tissues. Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites.

US Natl Inst Health; DailyMed. Current Medication Information for Skelaxin (metaxalone) tablet (June 2007). Available from, as of October 15, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4505

Peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 + or - 4.8 hours. Doubling the dose of skelaxin from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (Cmax) and area under the curve (AUC). Dose proportionality at doses above 800 mg has not been studied. The absolute bioavailability of metaxalone is not known

5.5 Metabolism/Metabolites

Probably hepatic.

Biotransformations...studied in dogs and in man. 5-(3-methyl-5-carboxyphenoxymethyl)-2-oxazolidinone, major metabolite, is excreted in urine and feces; this also occurs in urine as ester glucuronide. Fission of ether linkage...affords...3,5-xylenol and 5-hydroxymethyloxazolidinone. Oxazolidinone ring is stable in mammals.

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 1: A Review of the Literature Published Between 1960 and 1969. London: The Chemical Society, 1970., p. 175

Yields 5-(5-carboxy-3-methylphenoxymethyl)-2-oxazolidone in man & in dogs, yields 3,5-dimethylphenol in man and in dogs. /From table/

Goodwin, B.L. Handbook of Intermediary Metabolism of Aromatic Compounds. New York: Wiley, 1976., p. D-93

Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites.

5.6 Biological Half-Life

9.2 (+/- 4.8) hours

Terminal half-life /is/ 9.0 + or - 4.8 hours

5.7 Mechanism of Action

The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression.

Metaxalone is a CNS depressant that has sedative and skeletal muscle relaxant effects. The precise mechanism of action of the drug is not known. The skeletal muscle relaxant effects of orally administered metaxalone are minimal and are probably related to its sedative effect. The drug does not directly relax skeletal muscle and, unlike neuromuscular blocking agents, does not depress neuronal conduction, neuromuscular transmission, or muscle excitability.

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 1395

The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

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Import","activeIngredients":"METAXALONE","year":"2021","qtr":"Q2","strtotime":1618165800,"product":"METAXALONE USP","address":"NO.27,RACE COURSE ROAD,BANGALORE","city":"KARNATAKA","supplier":"QUANTUM CHEMICALS CO ","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG INT\\'L","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"350","totalValueFC":"697.2","currency":"USD","unitRateINR":"25952.5","date":"12-Apr-2021","totalValueINR":"51905","totalValueInUsd":"697.2","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"3530097","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG INT\\'L","supplierAddress":"","customerAddress":"NO.27,RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637692200,"product":"METAXALONE, USP(79 DRUMS) (DTL AS PER INV, PL 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919945641620","city":"BENGALURU","supplier":"HENGDIAN GROUP","supplierCountry":"CHINA","foreign_port":"NA","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"340.00","actualQuantity":"340","unit":"KGS","unitRateFc":"128","totalValueFC":"44154.7","currency":"USD","unitRateINR":"9734.4","date":"22-Feb-2022","totalValueINR":"3309696","totalValueInUsd":"44154.7","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"7601671","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 31, RACE COURSE ROAD BANGALORE Contact No: 919945641620"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679682600,"product":"METAXALONE, BATCH NO:0400000182","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"ANGELINI 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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"150","totalValueFC":"7560","currency":"USD","unitRateINR":"12682.5","date":"01-Aug-2024","totalValueINR":"634125","totalValueInUsd":"7560","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"4814915","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROME","supplierAddress":"VIALE AMELIA 70 00181 ROMA Roma, ,ITALYSDNF ITALY","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"METAXALONE LOT NO-0900000768","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"ANGELINI PHARMA","supplierCountry":"ITALY","foreign_port":"ROME","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"150","totalValueFC":"45360.2","currency":"USD","unitRateINR":"12682.5","date":"01-Aug-2024","totalValueINR":"3804750","totalValueInUsd":"45360.2","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"4814915","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROME","supplierAddress":"VIALE AMELIA 70 00181 ROMA Roma, ,ITALYSDNF ITALY","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"METAXALONE MICRO LOT: 0900000015","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"ANGELINI PHARMA","supplierCountry":"ITALY","foreign_port":"ANCONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"185","totalValueFC":"18703.3","currency":"USD","unitRateINR":"15715.8","date":"26-Oct-2024","totalValueINR":"1571575","totalValueInUsd":"18703.3","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"6359406","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANCONA","supplierAddress":"VIALE AMELIA, 70 00181 ROMA SDNF IT","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

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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DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 13217

DOSAGE - TABLET;ORAL - 800MG **Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 13217

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ABOUT THIS PAGE

Metaxalone Manufacturers

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

Metaxalone Suppliers

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

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

Metaxalone USDMF

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

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

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

Metaxalone WC

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

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

Metaxalone 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 Metaxalone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Metaxalone GMP

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

Metaxalone CoA

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

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

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

25 API Suppliers

19 USDMF

2 EU WC

8 NDC API

11 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers

12 FDA Orange Book

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders

51 Coating Systems & Additives

40 Direct Compression

28 Controlled & Modified Release

27 Lubricants & Glidants

24 Granulation

24 Disintegrants & Superdisintegrants

22 Thickeners and Stabilizers

16 Film Formers & Plasticizers

16 Co-Processed Excipients

13 Solubilizers

11 Taste Masking

10 Chewable & Orodispersible Aids

7 Emulsifying Agents

6 API Stability Enhancers

5 Rheology Modifiers

5 Empty Capsules

4 Vegetarian Capsules

TABLET;ORAL - 400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons