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Chemistry

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Also known as: 123441-03-2, Exelon, Ena 713 free base, Prometax, Rivastigmine teva, Nimvastid
Molecular Formula
C14H22N2O2
Molecular Weight
250.34  g/mol
InChI Key
XSVMFMHYUFZWBK-NSHDSACASA-N
FDA UNII
PKI06M3IW0

Rivastigmine
A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.
Rivastigmine is a Cholinesterase Inhibitor. The mechanism of action of rivastigmine is as a Cholinesterase Inhibitor.
1 2D Structure

Rivastigmine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methylcarbamate
2.1.2 InChI
InChI=1S/C14H22N2O2/c1-6-16(5)14(17)18-13-9-7-8-12(10-13)11(2)15(3)4/h7-11H,6H2,1-5H3/t11-/m0/s1
2.1.3 InChI Key
XSVMFMHYUFZWBK-NSHDSACASA-N
2.1.4 Canonical SMILES
CCN(C)C(=O)OC1=CC=CC(=C1)C(C)N(C)C
2.1.5 Isomeric SMILES
CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C
2.2 Other Identifiers
2.2.1 UNII
PKI06M3IW0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-n-ethyl-3-((1-dimethyl-amino)ethyl)-n-methylphenylcarbamate

2. 713, Ena

3. 713, Sdz Ena

4. Ena 713

5. Ena 713, Sdz

6. Ena-713

7. Ena713

8. Exelon

9. Hydrogen Tartrate, Rivastigmine

10. Rivastigmine Hydrogen Tartrate

11. Rivastigminetartrate

12. Sdz Ena 713

13. Tartrate, Rivastigmine Hydrogen

2.3.2 Depositor-Supplied Synonyms

1. 123441-03-2

2. Exelon

3. Ena 713 Free Base

4. Prometax

5. Rivastigmine Teva

6. Nimvastid

7. S-rivastigmine

8. Rivastigmine Hexal

9. (s)-rivastigmine

10. (s)-3-(1-(dimethylamino)ethyl)phenyl Ethyl(methyl)carbamate

11. Rivastigmine Sandoz

12. Sdz-ena-713

13. Sdz-212-713

14. [3-[(1s)-1-(dimethylamino)ethyl]phenyl] N-ethyl-n-methylcarbamate

15. M-((s)-1-(dimethylamino)ethyl)phenyl Ethylmethylcarbamate

16. (s)-3-(1-(dimethylamino)ethyl)phenyl Ethylmethylcarbamate

17. Chembl636

18. 3-[(1s)-1-(dimethylamino)ethyl]phenyl N-ethyl-n-methylcarbamate

19. Pki06m3iw0

20. Chebi:8874

21. Ena-713d

22. Ono-2540

23. Sdz-212713

24. 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ethyl(methyl)carbamate

25. Exelon Patch

26. Ethylmethylcarbamic Acid 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ester

27. Sr-05000001475

28. Unii-pki06m3iw0

29. Sdz 212-713

30. Rivastigmine Transdermal System

31. Prometax (tn)

32. Rivastigmine [usan:inn:ban:jan]

33. Rivastigmine.tartrate

34. Rivastigmine Impurity D

35. 3-((1s)-1-(dimethylamino)ethyl)phenyl Ethylmethylcarbamate

36. Rivastigmine [mi]

37. Rivastigmine [inn]

38. Rivastigmine [jan]

39. Carbamic Acid, Ethylmethyl-, 3-((1s)-1-(dimethylamino)ethyl)phenyl Ester

40. Rivastigmine [usan]

41. Schembl2764

42. Rivastigmine [vandf]

43. Rivastigmine [mart.]

44. Ethylmethylcarbamic Acid 3-[1-(dimethylamino)ethyl]phenyl Ester

45. Mls003876822

46. Bidd:gt0316

47. Rivastigmine [usp-rs]

48. Rivastigmine [who-dd]

49. Rivastigmine (jan/usp/inn)

50. Gtpl6602

51. Zinc4413

52. Rivastigmine [ema Epar]

53. Rivastigmine 1 A Pharma

54. Dtxsid7023564

55. Bdbm10620

56. Bdbm11682

57. Amy3808

58. Hms2089h18

59. Hms3715p15

60. Hms3885b18

61. Rivastigmine [orange Book]

62. Rivastigmine [ep Monograph]

63. Rivastigmine [usp Monograph]

64. Mfcd00871496

65. Akos015896334

66. Carbamic Acid, Ethylmethyl-, 3-(1-(dimethylamino)ethyl)phenyl Ester, (s)-

67. Ac-8250

68. Ccg-221197

69. Cs-0946

70. Db00989

71. Rivastigmine 3m Health Care Ltd

72. Ncgc00167531-03

73. Ncgc00167531-17

74. As-73448

75. Hy-17368

76. Smr002203623

77. R0250

78. S4687

79. (r)-rivastigmine (rivastigmine Ep Impurity D)

80. D03822

81. D82061

82. F10108

83. Ab01275472-01

84. Ab01275472_02

85. Ab01275472_03

86. 101r548

87. Q411887

88. Sr-05000001475-1

89. Sr-05000001475-2

90. W-200966

91. (s)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-n-methylcarbamate

92. [3-[(1s)-1-dimethylaminoethyl]phenyl] N-ethyl-n-methylcarbamate

93. 3-((1s)-1-(dimethylamino)ethyl)phenyl N-ethyl N-methyl Carbamate

94. Ethyl-methyl-carbamic Acid 3-(1-dimethylamino-ethyl)-phenyl Ester

95. Ethyl-methyl-carbamic Acid 3-((r)-1-dimethylamino-ethyl)-phenyl Ester

96. Ethyl-methyl-carbamic Acid 3-((s)-1-dimethylamino-ethyl)-phenyl Ester

97. Carbamic Acid, N-ethyl-n-methyl-, 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ester

98. 2,3-dihydroxybutanedioic Acid; 3-[(1s)-1-(dimethylamino)ethyl]phenyl N-ethyl-n-methylcarbamate

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 250.34 g/mol
Molecular Formula C14H22N2O2
XLogP32.3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass250.168127949 g/mol
Monoisotopic Mass250.168127949 g/mol
Topological Polar Surface Area32.8 Ų
Heavy Atom Count18
Formal Charge0
Complexity269
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 2  
Drug NameRivastigmine
PubMed HealthRivastigmine
Drug ClassesCentral Nervous System Agent
Drug LabelRivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological...
Active IngredientRivastigmine tartrate
Dosage FormSolution
Routeoral
Strength2mg/ml
Market StatusTentative Approval
CompanyRanbaxy

2 of 2  
Drug NameRivastigmine
PubMed HealthRivastigmine
Drug ClassesCentral Nervous System Agent
Drug LabelRivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological...
Active IngredientRivastigmine tartrate
Dosage FormSolution
Routeoral
Strength2mg/ml
Market StatusTentative Approval
CompanyRanbaxy

4.2 Drug Indication

For the treatment of mild to moderate dementia associated with Parkinson's disease or of the Alzheimer's type.


FDA Label


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.


Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


Treatment of dementia


Treatment of dementia


5 Pharmacology and Biochemistry
5.1 Pharmacology

Rivastigmine is a parasympathomimetic and a reversible cholinesterase inhibitor. An early pathophysiological feature of Alzheimer's disease that is associated with memory loss and cognitive deficits is a deficiency of acetylcholine as a result of selective loss of cholinergic neurons in the cerebral cortex, nucleus basalis, and hippocampus. Tacrine is postulated to exert its therapeutic effect by enhancing cholinergic function. While the precise mechanism of rivastigmine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this proposed mechanism is correct, rivastigmine's effect may lessen as the disease progresses and fewer cholinergic neurons remain functionally intact.


5.2 MeSH Pharmacological Classification

Neuroprotective Agents

Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)


Cholinesterase Inhibitors

Drugs that inhibit cholinesterases. The neurotransmitter ACETYLCHOLINE is rapidly hydrolyzed, and thereby inactivated, by cholinesterases. When cholinesterases are inhibited, the action of endogenously released acetylcholine at cholinergic synapses is potentiated. Cholinesterase inhibitors are widely used clinically for their potentiation of cholinergic inputs to the gastrointestinal tract and urinary bladder, the eye, and skeletal muscles; they are also used for their effects on the heart and the central nervous system. (See all compounds classified as Cholinesterase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
RIVASTIGMINE
5.3.2 FDA UNII
PKI06M3IW0
5.3.3 Pharmacological Classes
Cholinesterase Inhibitors [MoA]; Cholinesterase Inhibitor [EPC]
5.4 ATC Code

N06DA03


N06DA03


N06DA03


N06DA03


N06DA03


N06DA03


N06DA03


N06DA03


N06DA03

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


N - Nervous system

N06 - Psychoanaleptics

N06D - Anti-dementia drugs

N06DA - Anticholinesterases

N06DA03 - Rivastigmine


5.5 Absorption, Distribution and Excretion

Route of Elimination

Rivastigmine is extensively metabolized primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite NAP226-90. Renal excretion of the metabolites is the major route of elimination. Less than 1% of the administered dose is excreted in the feces.


Volume of Distribution

1.8 to 2.7 L/kg


Clearance

renal cl=2.1-2.8 L/hr


5.6 Metabolism/Metabolites

Rivastigmine is rapidly metabolized by cholinesterase-mediated hydrolysis.


5.7 Biological Half-Life

1.5 hours


5.8 Mechanism of Action

Rivastigmine is a carbamate derivative that is structurally related to physostigmine, but not to donepezil and tacrine. The precise mechanism of rivastigmine has not been fully determined, but it is suggested that rivastigmine binds reversibly with and inactivates chlolinesterase (eg. acetylcholinesterase, butyrylcholinesterase), preventing the hydrolysis of acetycholine, and thus leading to an increased concentration of acetylcholine at cholinergic synapses. The anticholinesterase activity of rivastigmine is relatively specific for brain acetylcholinesterase and butyrylcholinesterase compared with those in peripheral tissues.


Listed Suppliers

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Interquim SA

Spain
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  • WHO-GMP

Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Rivastigmine

About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...

Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs that meet stringent quality standards. Complying with European environmental and work safety regulations, Interquim’s products are exported to highly regulated pharmaceutical markets. Regulatory bodies and clients have approved its quality system and facilities. With state-of-the-art multi-production plants, drug synthesis, and quality-control labs, Interquim supports clients throughout the entire product lifecycle, from product development to marketing.
Interquim

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

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Rivastigmine

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.
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03

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Rivastigmine

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Arevipharma

Germany
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Arevipharma

Germany
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Rivastigmine

About the Company : Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based...

Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based pharmaceutical companies on five continents. Our business partners recognise us as a competent, reliable and efficient company that is distinguished by individual service and an innovative character. The company’s 140 year history is based on the knowledge, skills, commitment and loyalty of its employees. Arevipharma also feels committed to its owners and investors. Due to the consistent expansion of new technologies,
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Rivastigmine

About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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Rivastigmine

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

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

About the Company : ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIE...

ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIERRE we employ more than 220 people and two manufacturing sites, San Paolo d’Argon and Sovere, are both FDA inspected with no 483 form. We provide APIs of the highest quality and we are a reliable partner for the pharmaceutical industry worldwide.
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Rivastigmine

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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About the Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most prestigious pharma co...

Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most prestigious pharma companies. It is WHO-GMP, ISO 9001-2008 and ISO 14000:2004 certified. Shodhana develops quality products through cutting-edge research, expertise and the best drug manufacturing practices. Its manufacturing processes are as per ICH guidelines and cGMP-compliant. Shodhana also has a world-class R&D lab manned by a team of highly qualified scientists. Shodhana exports the highest-quality APIs and intermediates to markets across several countries.
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Rivastigmine

About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...

Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals Ingredients (API'S) for wide range of therapeutic categories. Therapeutic segments of focus are Anti Fungals, Anti Depressants, and Anti Hypertensive. Synergene manufacturing facilities are cGMP compliant meeting global standards in terms of infrastructure and systems. The company has two manufacturing facilities located at Hyderabad & Vishakhapatnam manufacturing Active Pharmaceutical Ingredients and Intermediates.
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07-Feb-2022
14-May-2025
KGS
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01

arrow
EPS
Not Confirmed

Gowlings

Canada
arrow
EPS
Not Confirmed

Rivastigmine

Brand Name : EXELON PATCH 5

Patent Number : 2315784

Filing Date : 1999-01-08

Strength per Unit : 9.0mg / 5cm

Dosage Form : Patch

Human Or VET : Human

Route of Administration : Transdermal

Patent Expiration Date : 2019-01-08

Date Granted : 2006-06-27

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02

arrow
EPS
Not Confirmed

Gowlings

Canada
arrow
EPS
Not Confirmed

Rivastigmine

Brand Name : EXELON PATCH 10

Patent Number : 2315784

Filing Date : 1999-01-08

Strength per Unit : 18.0mg / 10cm

Dosage Form : Patch

Human Or VET : Human

Route of Administration : Transdermal

Patent Expiration Date : 2019-01-08

Date Granted : 2006-06-27

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03

arrow
EPS
Not Confirmed

Gowlings

Canada
arrow
EPS
Not Confirmed

Rivastigmine

Brand Name : EXELON PATCH 15

Patent Number : 2315784

Filing Date : 1999-01-08

Strength per Unit : 27.0 mg / 15 cm

Dosage Form : PATCH

Human Or VET : Human

Route of Administration : TRANSDERMAL

Patent Expiration Date : 2019-01-08

Date Granted : 2006-06-27

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04

arrow
EPS
Not Confirmed

Country
arrow
EPS
Not Confirmed

Rivastigmine

Brand Name :

Patent Number : 1284501

Filing Date :

Strength per Unit :

Dosage Form :

Human Or VET :

Route of Administration :

Patent Expiration Date : 2008-05-28

Date Granted :

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05

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EPS
Not Confirmed

Country
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EPS
Not Confirmed

Rivastigmine

Brand Name :

Patent Number : 1302853

Filing Date :

Strength per Unit :

Dosage Form :

Human Or VET :

Route of Administration :

Patent Expiration Date : 2009-09-01

Date Granted :

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06

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EPS
Not Confirmed

Country
arrow
EPS
Not Confirmed

Rivastigmine

Brand Name :

Patent Number : 1307003

Filing Date :

Strength per Unit :

Dosage Form :

Human Or VET :

Route of Administration :

Patent Expiration Date : 2009-09-01

Date Granted :

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ABOUT THIS PAGE

Looking for 123441-03-2 / Rivastigmine API manufacturers, exporters & distributors?

Rivastigmine manufacturers, exporters & distributors 1

23

PharmaCompass offers a list of Rivastigmine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rivastigmine manufacturer or Rivastigmine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rivastigmine manufacturer or Rivastigmine supplier.

PharmaCompass also assists you with knowing the Rivastigmine API Price utilized in the formulation of products. Rivastigmine API Price is not always fixed or binding as the Rivastigmine Price is obtained through a variety of data sources. The Rivastigmine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Rivastigmine

Synonyms

123441-03-2, Exelon, Ena 713 free base, Prometax, Rivastigmine teva, Nimvastid

Cas Number

123441-03-2

Unique Ingredient Identifier (UNII)

PKI06M3IW0

About Rivastigmine

A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.

Rivastigmine Manufacturers

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

Rivastigmine Suppliers

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

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

Rivastigmine USDMF

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

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

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

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

Rivastigmine KDMF

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

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

After submitting a Rivastigmine 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 Rivastigmine API can apply through the Korea Drug Master File (KDMF).

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

Rivastigmine CEP

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

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

Rivastigmine WC

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

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

Rivastigmine 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 Rivastigmine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rivastigmine GMP

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

Rivastigmine CoA

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

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

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