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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
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
| Molecular Weight | 250.34 g/mol |
|---|---|
| Molecular Formula | C14H22N2O2 |
| XLogP3 | 2.3 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 5 |
| Exact Mass | 250.168127949 g/mol |
| Monoisotopic Mass | 250.168127949 g/mol |
| Topological Polar Surface Area | 32.8 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 269 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Rivastigmine |
| PubMed Health | Rivastigmine |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Rivastigmine 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 Ingredient | Rivastigmine tartrate |
| Dosage Form | Solution |
| Route | oral |
| Strength | 2mg/ml |
| Market Status | Tentative Approval |
| Company | Ranbaxy |
| 2 of 2 | |
|---|---|
| Drug Name | Rivastigmine |
| PubMed Health | Rivastigmine |
| Drug Classes | Central Nervous System Agent |
| Drug Label | Rivastigmine 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 Ingredient | Rivastigmine tartrate |
| Dosage Form | Solution |
| Route | oral |
| Strength | 2mg/ml |
| Market Status | Tentative Approval |
| Company | Ranbaxy |
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
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.
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.)
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
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
Rivastigmine is rapidly metabolized by cholinesterase-mediated hydrolysis.
1.5 hours
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.
API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2017-08-21
Registration Number : 20170821-184-I-519-16
Manufacturer Name : Interquim, SA
Manufacturer Address : c/ Joan Buscallà, 10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
| Available Reg Filing : ASMF, CA, CN |
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-28
Pay. Date : 2013-03-20
DMF Number : 22974
Submission : 2009-07-22
Status : Active
Type : II
Certificate Number : R1-CEP 2013-354 - Rev 00
Issue Date : 2020-01-23
Type : Chemical
Substance Number : 2629
Status : Valid
Registration Number : 301MF10032
Registrant's Address : Joan Buscala, 10 E-08173 Sant Cugat del Valles, Barcelona, Spain
Initial Date of Registration : 2019-07-19
Latest Date of Registration :
Registrant Name : Samyang Holdings Co., Ltd.
Registration Date : 2017-12-08
Registration Number : 20170821-184-I-519-16(2)
Manufacturer Name : Interquim, SA
Manufacturer Address : c/ Joan Buscallà,10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
| Available Reg Filing : ASMF, CA, CN |
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Shinil Pharmaceutical Co., Ltd.
Registration Date : 2017-11-27
Registration Number : 20170821-184-I-519-16(1)
Manufacturer Name : Interquim, SA
Manufacturer Address : c/ Joan Buscalla, 10, 08173 Sant Cugat del Vallaes (Barcelona), Spain
| Available Reg Filing : ASMF, CA, CN |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-12
Pay. Date : 2014-08-07
DMF Number : 24502
Submission : 2011-03-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-29
Pay. Date : 2013-09-24
DMF Number : 25871
Submission : 2011-12-22
Status : Active
Type : II
Registration Number : 228MF10192
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2016-10-05
Latest Date of Registration :
NDC Package Code : 49706-1825
Start Marketing Date : 2013-10-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Essel Bio Co., Ltd.
Registration Date : 2023-04-06
Registration Number : 20210924-184-I-627-20(1)
Manufacturer Name : Erregierre SpA
Manufacturer Address : Via F. Baracca, 19-24060 San Paolo D'Argon (BG), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-28
Pay. Date : 2016-09-23
DMF Number : 29826
Submission : 2015-09-08
Status : Active
Type : II
Certificate Number : R1-CEP 2014-291 - Rev 01
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 2629
Status : Valid
Registration Number : 303MF10138
Registrant's Address : SE-691 85 Karlskoga, SWEDEN
Initial Date of Registration : 2021-08-25
Latest Date of Registration :
NDC Package Code : 12651-118
Start Marketing Date : 2017-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-01
Pay. Date : 2015-03-12
DMF Number : 29033
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22683
Submission : 2009-04-01
Status : Inactive
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
Registrant Name : Novartis Korea Ltd.
Registration Date : 2020-09-15
Registration Number : 20200915-184-I-600-19
Manufacturer Name : Hetero Drugs Limited(Unit-IX)
Manufacturer Address : Plot No.1, Hetero Infrastructure SEZ Ltd., N. Narasapuram (V), Nakkapalli Mandal, Anakapalli District-531081, Andhra Pradesh, India
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USDMF
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Certificate Number : R1-CEP 2013-354 - Rev 00
Status : Valid
Issue Date : 2020-01-23
Type : Chemical
Substance Number : 2629
Certificate Number : R1-CEP 2015-039 - Rev 00
Status : Valid
Issue Date : 2020-11-24
Type : Chemical
Substance Number : 2629
Certificate Number : R1-CEP 2014-291 - Rev 01
Status : Valid
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 2629
Certificate Number : R1-CEP 2015-279 - Rev 00
Status : Valid
Issue Date : 2022-09-23
Type : Chemical
Substance Number : 2629
Certificate Number : R1-CEP 2015-276 - Rev 00
Status : Valid
Issue Date : 2023-01-25
Type : Chemical
Substance Number : 2629
Certificate Number : R1-CEP 2015-236 - Rev 00
Status : Valid
Issue Date : 2022-08-19
Type : Chemical
Substance Number : 2629
Certificate Number : CEP 2012-304 - Rev 02
Status : Valid
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2629
Certificate Number : R0-CEP 2012-408 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2016-12-09
Type : Chemical
Substance Number : 2629
Certificate Number : R0-CEP 2013-080 - Rev 00
Status : Expired
Issue Date : 2015-02-18
Type : Chemical
Substance Number : 2629
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Average Price (USD/KGS) |
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ABOUT THIS PAGE
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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.
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.
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Rivastigmine API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
