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Chemistry

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Also known as: 196597-26-9, Rozerem, Tak-375, (s)-n-[2-(1,6,7,8-tetrahydro-2h-indeno-[5,4-b]furan-8-yl)ethyl]propionamide, (s)-n-(2-(1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl)ethyl)propionamide, Tak375
Molecular Formula
C16H21NO2
Molecular Weight
259.34  g/mol
InChI Key
YLXDSYKOBKBWJQ-LBPRGKRZSA-N
FDA UNII
901AS54I69

Ramelteon
Ramelteon is a synthetic melatonin analogue with hypnotic and circadian rhythm-modulating activities. Ramelteon binds to and activates melatonin receptors 1 and 2 in the suprachiasmatic nucleus (SCN) of the brain, thereby promoting the onset of sleep. Unlike the nonbenzodiazepine sedative hypnotics zolpidem and zaleplon, this agent does not activate GABA receptors and, so, produces no GABA receptor-mediated anxiolytic, myorelaxant, and amnesic effects.
Ramelteon is a Melatonin Receptor Agonist. The mechanism of action of ramelteon is as a Melatonin Receptor Agonist.
1 2D Structure

Ramelteon

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e][1]benzofuran-8-yl]ethyl]propanamide
2.1.2 InChI
InChI=1S/C16H21NO2/c1-2-15(18)17-9-7-12-4-3-11-5-6-14-13(16(11)12)8-10-19-14/h5-6,12H,2-4,7-10H2,1H3,(H,17,18)/t12-/m0/s1
2.1.3 InChI Key
YLXDSYKOBKBWJQ-LBPRGKRZSA-N
2.1.4 Canonical SMILES
CCC(=O)NCCC1CCC2=C1C3=C(C=C2)OCC3
2.1.5 Isomeric SMILES
CCC(=O)NCC[C@@H]1CCC2=C1C3=C(C=C2)OCC3
2.2 Other Identifiers
2.2.1 UNII
901AS54I69
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-n-(2-(1,6,7,8-tetrahydro-2h-indeno-(5,4)furan-8-yl)ethyl)propionamide

2. Rozerem

3. Tak-375

2.3.2 Depositor-Supplied Synonyms

1. 196597-26-9

2. Rozerem

3. Tak-375

4. (s)-n-[2-(1,6,7,8-tetrahydro-2h-indeno-[5,4-b]furan-8-yl)ethyl]propionamide

5. (s)-n-(2-(1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl)ethyl)propionamide

6. Tak375

7. Chembl1218

8. 901as54i69

9. Ramelteon [usan]

10. N-[2-[(8s)-2,6,7,8-tetrahydro-1h-cyclopenta[e][1]benzofuran-8-yl]ethyl]propanamide

11. N-[2-[(8s)-1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl]ethyl]propanamide

12. N-{2-[(8s)-1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl]ethyl}propanamide

13. N-{2-[(8s)-1h,2h,6h,7h,8h-indeno[5,4-b]furan-8-yl]ethyl}propanamide

14. Smr002544684

15. Rozerem (tn)

16. Sr-05000001957

17. Ramelteon (jan/usan/inn)

18. (s)-n-(2-(1,6,7,8-tetrahydro-2h-indeno-(5,4)furan-8-yl)ethyl)propionamide

19. Unii-901as54i69

20. Hsdb 7787

21. Ramelteon Solution

22. (s)-n-(2-[1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl]ethyl)propionamide

23. (s)-n-[2-(1,6,7,8-tetrahydro-2h-indeno[5,4-b]furan-8-yl)ethyl]propionamide

24. Ramelteon [usan:inn:ban:jan]

25. Jev

26. Ramelteon [inn]

27. Ramelteon [jan]

28. Ramelteon [hsdb]

29. Ramelteon [vandf]

30. Ramelteon (tak-375)

31. Ramelteon [mart.]

32. Ramelteon [who-dd]

33. (-)-n-(2-(((8s)-1,6,7,8-tetrahydro-2h-indeno(5,4-b)furan-8-yl)ethyl)propanamide

34. Schembl29237

35. Bspbio_002318

36. Mls003915619

37. Mls006010029

38. Tak-375sl

39. Spectrum1505817

40. Gtpl1356

41. Ramelteon [orange Book]

42. Dtxsid6045951

43. Tak 375

44. Chebi:109549

45. Hms1922h18

46. Hms2093f12

47. Hms3884k07

48. Act06830

49. Hy-a0014

50. Zinc3960338

51. Bdbm50118470

52. Mfcd08067736

53. S1259

54. Ramelteon 1.0 Mg/ml In Acetonitrile

55. Akos015895741

56. Ac-5275

57. Am84670

58. Ccg-213557

59. Cs-0382

60. Db00980

61. N-[2-[(8s)-2,6,7,8-tetrahydro-1h-cyclopenta[e]benzofuran-8-yl]ethyl]propanamide

62. Propanamide, N-(2-((8s)-1,6,7,8-tetrahydro-2h-indeno(5,4-b)furan-8-yl)ethyl)-

63. Ncgc00178707-03

64. Ncgc00178707-05

65. As-15740

66. Sbi-0206874.p001

67. R0216

68. Sw219712-1

69. D02689

70. Ab01274760-01

71. Ab01274760_02

72. Ab01274760_03

73. 597r269

74. Q417689

75. J-502508

76. Sr-05000001957-1

77. Sr-05000001957-3

78. Brd-k28761891-001-01-0

79. Brd-k28761891-001-04-4

80. Z2037281108

81. 1-boc-2-[(4-fluoro-phenylamino)-methyl]-piperidine

82. (s)-n-(2-(2,6,7,8-tetrahydro-1h-indeno[5,4-b]furan-8-yl)ethyl)propionamide

83. N-[2-(1,6,7,8-tetrahydro-2h-3-oxa-as-indacen-8-yl)-ethyl]-propionamide(s)-(-)-22b

84. N-[2-[(8s)-2,6,7,8-tetrahydro-1h-cyclopenta[e][1]benzoxol-8-yl]ethyl]propanamide

85. Ramelteon Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

86. (-)-n-(2-(((8s)-1,6,7,8-tetrahydro-2h-indeno(5,4-.beta.)furan-8-yl)ethyl)propanamide

87. Propanamide, N-(2-((8s)-1,6,7,8-tetrahydro-2h-indeno(5,4-.beta.)furan-8-yl)ethyl)-

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 259.34 g/mol
Molecular Formula C16H21NO2
XLogP32.7
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count4
Exact Mass259.157228913 g/mol
Monoisotopic Mass259.157228913 g/mol
Topological Polar Surface Area38.3 Ų
Heavy Atom Count19
Formal Charge0
Complexity331
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameRamelteon
PubMed HealthRamelteon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical...
Active IngredientRamelteon
Dosage FormTablet
RouteOral
Strength8mg
Market StatusPrescription
CompanyTeva Pharms Usa

2 of 4  
Drug NameRozerem
PubMed HealthRamelteon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical...
Active IngredientRamelteon
Dosage FormTablet
RouteOral
Strength8mg
Market StatusPrescription
CompanyTakeda Pharms Usa

3 of 4  
Drug NameRamelteon
PubMed HealthRamelteon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical...
Active IngredientRamelteon
Dosage FormTablet
RouteOral
Strength8mg
Market StatusPrescription
CompanyTeva Pharms Usa

4 of 4  
Drug NameRozerem
PubMed HealthRamelteon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical...
Active IngredientRamelteon
Dosage FormTablet
RouteOral
Strength8mg
Market StatusPrescription
CompanyTakeda Pharms Usa

4.2 Therapeutic Uses

Ramelteon is used in the management of insomnia characterized by difficulty with sleep onset. /Use Included in US product label/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2634


THERAPEUTIC CATEGORY: Sedative, hypnotic

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 2006., p. 1395


4.3 Drug Warning

Ramelteon did not demonstrate a respiratory depressant effect in patients with mild to moderate chronic obstructive pulmonary disease. The effect of ramelteon in patients with severe chronic obstructive pulmonary disease (e.g., those with elevated PCO2, those requiring nocturnal oxygen therapy) has not been studied, and use in these patients is not recommended. In studies in patients with mild to moderate obstructive sleep apnea, ramelteon did not produce differences in measures of apnea indices.1 However, the effect of ramelteon on severe obstructive sleep apnea has not been studied, and use in these patients is not recommended.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2634


In a 35-night randomized study evaluating next-day residual effects of ramelteon, adult patients receiving 8 mg of the drug every night experienced reduced immediate/delayed memory recall and increased sluggishness, fatigue, and irritation at weeks 1 and 3 of treatment compared with those receiving placebo. However, next-day residual effects were not substantially different between ramelteon- and placebo-treated patients at week 5.1 2 A similar study in geriatric patients receiving 4 or 8 mg of ramelteon every night did not produce any substantial differences in measures of residual effects.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2634


Studies employing subjective measures (e.g., questionnaires) did not reveal evidence of a withdrawal syndrome (including rebound insomnia) following discontinuance of long-term ramelteon therapy (4, 8, or 16 mg daily for up to 35 days).

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2634


No evidence of abuse potential was detected following administration of relatively high ramelteon doses (up to 20 times the recommended hypnotic dose) in patients with a history of drug (e.g., sedative-hypnotic, anxiolytic) abuse or dependence. Ramelteon does not appear to produce physical dependence.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2633


For more Drug Warnings (Complete) data for Ramelteon (18 total), please visit the HSDB record page.


4.4 Drug Indication

For the treatment of insomnia characterized by difficulty with sleep onset.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ramelteon is the first selective melatonin agonist. It works by mimicking melatonin (MT), a naturally occuring hormone that is produced during the sleep period and thought to be responsible for the regulation of circadian rhythm underlying the normal sleep-wake cycle. Ramelteon has a high affinity for the MT1 and MT2 receptors. The MT1 and MT2 receptors are located in the brain's suprachiasmatic nuclei (SCN),which is known as the body's "master clock" because it regulates the 24-hour sleep-wake cycle. Ramelteon has an active metabolite that is less potent but circulates in higher concentrations than the parent compound. The metabolite also has weak affinity for the 5HT2b receptor.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
RAMELTEON
5.2.2 FDA UNII
901AS54I69
5.2.3 Pharmacological Classes
Melatonin Receptor Agonists [MoA]; Melatonin Receptor Agonist [EPC]
5.3 ATC Code

N - Nervous system

N05 - Psycholeptics

N05C - Hypnotics and sedatives

N05CH - Melatonin receptor agonists

N05CH02 - Ramelteon


5.4 Absorption, Distribution and Excretion

Absorption

Rapid, total absorption is at least 84%.


Route of Elimination

Following oral administration of radiolabeled ramelteon, 84% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 88%. Less than 0.1% of the dose was excreted in urine and feces as the parent compound.


Volume of Distribution

73.6 L


In vitro protein binding of ramelteon is approximately 82% in human serum, independent of concentration. Binding to albumin accounts for most of that binding, since 70% of the drug is bound in human serum albumin. Ramelteon is not distributed selectively to red blood cells. Ramelteon has a mean volume of distribution after intravenous administration of 73.6 L, suggesting substantial tissue distribution.

US Natl Inst Health; DailyMed. Current Medication Information for ROZEREM (ramelteon) tablet, film-coated (October 2008). Available from, as of February 16, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13323


Ramelteon is absorbed rapidly, with median peak concentrations occurring at approximately 0.75 hour (range, 0.5 to 1.5 hours) after fasted oral administration. Although the total absorption of ramelteon is at least 84%, the absolute oral bioavailability is only 1.8% due to extensive first-pass metabolism

US Natl Inst Health; DailyMed. Current Medication Information for ROZEREM (ramelteon) tablet, film-coated (October 2008). Available from, as of February 16, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13323


Distributed into milk in rats; not known whether ramelteon is distributed into human milk.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2634


Following oral administration of radiolabeled ramelteon, 84% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 88%. Less than 0.1% of the dose was excreted in urine and feces as the parent compound. Elimination was essentially complete by 96 hours post-dose. Repeated once daily dosing with Rozerem does not result in significant accumulation owing to the short elimination half-life of ramelteon (on average, approximately 1- 2.6 hours). The half-life of M-II is 2 to 5 hours and independent of dose. Serum concentrations of the parent drug and its metabolites in humans are at or below the lower limits of quantitation within 24 hours

US Natl Inst Health; DailyMed. Current Medication Information for ROZEREM (ramelteon) tablet, film-coated (October 2008). Available from, as of February 16, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13323


5.5 Metabolism/Metabolites

Hepatic


Metabolism of ramelteon consists primarily of oxidation to hydroxyl and carbonyl derivatives, with secondary metabolism producing glucuronide conjugates. CYP1A2 is the major isozyme involved in the hepatic metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree. The rank order of the principal metabolites by prevalence in human serum is M-II, M-IV, M-I, and M-III. These metabolites are formed rapidly and exhibit a monophasic decline and rapid elimination. The overall mean systemic exposure of M-II is approximately 20- to 100-fold higher than parent drug.

US Natl Inst Health; DailyMed. Current Medication Information for ROZEREM (ramelteon) tablet, film-coated (October 2008). Available from, as of February 16, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13323


5.6 Biological Half-Life

~1-2.6 hours


5.7 Mechanism of Action

Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors, and lower selectivity for the MT3 receptor. Melatonin production is concurrent with nocturnal sleep, meaning that an increase in melatonin levels is related to the onset of self-reported sleepiness and an increase in sleep propensity. MT1 receptors are believed to be responsible for regulation of sleepiness and facilitation of sleep onset, and MT2 receptors are believed to mediate phase-shifting effects of melatonin on the circadian rhythm. While MT1 and MT2 receptors are associated with the sleep-wake cycle, MT3 has a completely different profile, and therefore is not likely to be involved in the sleep-wake cycle. Remelteon has no appreciable affinity for the gamma-aminobutyric acid (GABA) receptor complex or receptors that bind neuropeptides, cytokines, serotonin, dopamine, norepinephrine, acetylcholine, or opiates.


Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and selectivity over the MT3 receptor. Ramelteon demonstrates full agonist activity in vitro in cells expressing human MT1 or MT2 receptors. The activity of ramelteon at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine, and opiates. Ramelteon also does not interfere with the activity of a number of selected enzymes in a standard panel. The major metabolite of ramelteon, M-II, is active and has approximately one tenth and one fifth the binding affinity of the parent molecule for the human MT1 and MT2 receptors, respectively, and is 17- to 25-fold less potent than ramelteon in in vitro functional assays. Although the potency of M-II at MT1 and MT2 receptors is lower than the parent drug, M-II circulates at higher concentrations than the parent producing 20- to 100-fold greater mean systemic exposure when compared to ramelteon. M-II has weak affinity for the serotonin 5-HT2B receptor, but no appreciable affinity for other receptors or enzymes. Similar to ramelteon, M-II does not interfere with the activity of a number of endogenous enzymes. All other known metabolites of ramelteon are inactive

US Natl Inst Health; DailyMed. Current Medication Information for ROZEREM (ramelteon) tablet, film-coated (October 2008). Available from, as of February 16, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13323


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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722796200,"product":"ACTIVE PHARMACEUTICALS INGREDIENT(API) PACKED IN 50 LTR HDPE DRUM NAME OF API:RAMELTEON","address":"25","city":"CHENNAI, TAMILNADU","supplier":"NURAY CHEMICALS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. 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K","customer":"THE PURCHASE MANAGER.*","customerCountry":"UNITED STATES","quantity":"8.64","actualQuantity":"8.64","unit":"KGS","unitRateFc":"11000","totalValueFC":"93786.4","currency":"USD","unitRateINR":916026.1574074073,"date":"11-Nov-2024","totalValueINR":"7914466","totalValueInUsd":"93786.4","indian_port":"Madras Air","hs_no":"29221990","bill_no":"5518362","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"25, CHENNAI, TAMILNADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"RAMELTEON","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"NEW IN CO. 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05-Jan-2021
28-Dec-2024
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ABOUT THIS PAGE

Ramelteon Manufacturers

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

Ramelteon Suppliers

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

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

Ramelteon USDMF

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

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

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

Ramelteon 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 Ramelteon Drug Master File in Japan (Ramelteon JDMF) empowers Ramelteon 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 Ramelteon JDMF during the approval evaluation for pharmaceutical products. At the time of Ramelteon 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 Ramelteon suppliers with JDMF on PharmaCompass.

Ramelteon WC

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

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

Ramelteon 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 Ramelteon as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ramelteon GMP

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

Ramelteon CoA

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

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

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