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1. 2-(acetylamino)-3-methoxy-n-(phenylmethyl)-, (2r)-
2. Add-234037
3. Ertosamide
4. Harkoseride
5. Spm-927
1. 175481-36-4
2. Erlosamide
3. Vimpat
4. (r)-2-acetamido-n-benzyl-3-methoxypropanamide
5. Harkoseride
6. Spm 927
7. Spm-927
8. (2r)-2-acetamido-n-benzyl-3-methoxypropanamide
9. (r)-lacosamide 1
10. Propanamide, 2-(acetylamino)-3-methoxy-n-(phenylmethyl)-, (2r)-
11. Add 243037
12. Add-234037
13. Chembl58323
14. 563ks2pqy5
15. Add-243037
16. Erlosamide [inn]
17. Ncgc00253740-01
18. (r)-2-acetamido-n-benzyl-3-methoxypropionamide.
19. (r)-2-acetylamino-n-benzyl-3-methoxy-propionamide
20. Lacosamide [usan]
21. (+)-(2r)-2-(acetylamino)-n-benzyl-3-methoxypropanamide
22. Ertosamide
23. Add 234037
24. Harkeroside
25. Unii-563ks2pqy5
26. Lacosamide [usan:inn:ban]
27. Lacosamide Cv
28. Spm-929
29. Lacosamide Racemate
30. Lacosamide- Bio-x
31. (2r)-2-(acetylamino)-n-benzyl-3-methoxypropanamide
32. Vimpat (tn)
33. Lacosamide [mi]
34. Lacosamide [inn]
35. Lacosamide [jan]
36. Lacosamide [vandf]
37. Lacosamide [mart.]
38. (r)-n-benzyl-2-acetamido-3-methoxypropionamide
39. Dsstox_cid_31455
40. Dsstox_rid_97341
41. Lacosamide [who-dd]
42. Dsstox_gsid_57666
43. Schembl35330
44. Lacosamide (jan/usan/inn)
45. Lacosamide [ema Epar]
46. Gtpl7472
47. Zinc7673
48. Dea No. 2746
49. Lacosamide Cv [usp-rs]
50. Dtxsid1057666
51. Lacosamide [orange Book]
52. Lacosamide [ep Monograph]
53. Chebi:135939
54. Lacosamide [usp Monograph]
55. Bcp02197
56. Tox21_113857
57. Bdbm50300204
58. Mfcd08272557
59. Akos005146274
60. Lacosamide 1.0 Mg/ml In Acetonitrile
61. Cs-0529
62. Db06218
63. Ks-1227
64. Ac-22750
65. Am808141
66. Bl164605
67. Hy-13015
68. A3897
69. Bb 0260890
70. Cas-175481-36-4
71. (r)-n-benzyl-2-acetamido-3-methoxypropanamide
72. D07299
73. (2r)-n-benzyl-2-acetamido-3-methoxypropanamide
74. (r)-2-acetamido-n-benzyl-3-methoxypropionamide
75. (r)-n-benzyl 2-acetamido-3-methoxypropionamide
76. (r)-n-benzyl 2-acetamido-3-methoxypropionamide,
77. Ab01559947-01
78. (2r)-2-acetylamino-n-benzyl-3-methoxypropanamide
79. (r)-2-acetylamino-n-benzyl-3-methoxypropionamide
80. 481l364
81. Ar-270/11402703
82. Q420077
83. Sr-01000942286
84. Sr-01000942286-1
85. (2r)-2-acetamido-3-methoxy-n-(phenylmethyl)propanamide
86. 2-(acetylamino)-3-methoxy-n-(phenylmethyl)-, (2r)-
87. Z1550648754
88. Lacosamide Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material
| Molecular Weight | 250.29 g/mol |
|---|---|
| Molecular Formula | C13H18N2O3 |
| XLogP3 | 0.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 6 |
| Exact Mass | 250.13174244 g/mol |
| Monoisotopic Mass | 250.13174244 g/mol |
| Topological Polar Surface Area | 67.4 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 275 |
| 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 | Vimpat |
| PubMed Health | Lacosamide |
| Drug Classes | Anticonvulsant |
| Active Ingredient | Lacosamide |
| Dosage Form | Tablet; Solution |
| Route | Oral; Intravenous |
| Strength | 200mg/20ml (10mg/ml); 200mg; 150mg; 10mg/ml; 100mg; 50mg |
| Market Status | Prescription |
| Company | Ucb |
| 2 of 2 | |
|---|---|
| Drug Name | Vimpat |
| PubMed Health | Lacosamide |
| Drug Classes | Anticonvulsant |
| Active Ingredient | Lacosamide |
| Dosage Form | Tablet; Solution |
| Route | Oral; Intravenous |
| Strength | 200mg/20ml (10mg/ml); 200mg; 150mg; 10mg/ml; 100mg; 50mg |
| Market Status | Prescription |
| Company | Ucb |
Lacosamide is indicated for adjunctive therapy for partial onset seizures in patients with epilepsy over 17 years old. Injection is indicated for short term use when oral therapy is not feasible.
FDA Label
Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Lacosamide Accord is indicated as adjunctive therapy
in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Treatment of epilepsy with partial-onset seizures
Treatment of generalised epilepsy and epileptic syndromes
Lacosamide therapy is correlated with a decrease in seizure frequency. It should be noted that in group analyses, dosages above 400 mg/day do not appear to result in additional benefit.
N03AX18
N03AX18
N03AX18
N03AX18
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
N03 - Antiepileptics
N03A - Antiepileptics
N03AX - Other antiepileptics
N03AX18 - Lacosamide
Absorption
Lacosamide has a negligible first pass effect with bioavailability of about 100%. The maximum Lacosamide plasma concentrations occur about 1-4 hours after oral administration, and the pharmacokinetics of Lacosamide are dose proportional. Food does not affect absorption.
Route of Elimination
Lacosamide is eliminated primarily from the systemic circulation by biotransformation and renal excretion.
Volume of Distribution
approximately 0.6 L/kg; thus close to the volume of total body water.
Clearance
95% recovered in the urine 0.5% in the feces
Lacosamide is a CYP2C19 substrate. The relative contribution of other CYP isoforms or non-CYP enzymes in the metabolism of lacosamide is not known. Primary compounds excreted were unchanged lacosamide (approximately 40% of the dose), its O-desmethyl metabolite (approximately 30%), and a structurally unknown polar fraction (~20%). The plasma exposure of the major human metabolite, O-desmethyl-lacosamide, is approximately 10% of that of lacosamide. This metabolite has no known pharmacological activity.
13 Hours
It is proposed that lacosamide's inhibition of sodium channels is responsible for analgesia. Lacosamide may be selective for inhibiting depolarized neurons rather than neurons with normal resting potentials. Pain and nociceptor hyperexcitability are associated with neural membrane depolarization. Lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is expressed primarily in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth. The role CRMP-2 of binding in seizure control is hasn't been elucidated.
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Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Certificate Number : R0-CEP 2021-451 - Rev 01
Issue Date : 2023-05-16
Type : Chemical
Substance Number : 2992
Status : Valid
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Number : 38789
Submission : 2023-09-28
Status : Active
Type : II
Certificate Number : CEP 2023-365 - Rev 01
Issue Date : 2025-01-14
Type : Chemical
Substance Number : 2992
Status : Valid
NDC Package Code : 42765-060
Start Marketing Date : 2023-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-14
Pay. Date : 2012-10-25
DMF Number : 26381
Submission : 2012-09-27
Status : Active
Type : II
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DMF Number : 37446
Submission : 2022-08-30
Status : Active
Type : II
NDC Package Code : 71901-611
Start Marketing Date : 2023-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-05-16
Registration Number : Su258-19-ND
Manufacturer Name : Emnar Pharma Pvt Ltd
Manufacturer Address : Unit-II, Plot No. 15, Jawaharlal Nehru Pharma City, Tadi (Village), Parawada Mandal, Anakapilli District-531019, Andhra Pradesh, India.
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DMF Number : 33552
Submission : 2019-02-04
Status : Active
Type : II
Certificate Number : R0-CEP 2019-048 - Rev 00
Issue Date : 2020-10-26
Type : Chemical
Substance Number : 2992
Status : Valid
Registration Number : 306MF10107
Registrant's Address : New No. 60, Old No. 35, Venkata Narayana Road, T. NagarChennai 600017 India
Initial Date of Registration : 2024-07-31
Latest Date of Registration :
Date of Issue : 2021-03-12
Valid Till : 2024-01-24
Written Confirmation Number : WC-0291n
Address of the Firm :
NDC Package Code : 52038-005
Start Marketing Date : 2019-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-05-29
Registration Number : No. 163-19-ND(2)
Manufacturer Name : Venkata Narayana Active Ingredients Private Limited
Manufacturer Address : Sy. No. 69, Chandrapadiya Village, Vinjamur Mandal, SPSR Nellore District-524228, Andhra Pradesh, India
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Rev. Date :
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DMF Number : 33678
Submission : 2019-03-21
Status : Active
Type : II
Certificate Number : CEP 2019-041 - Rev 01
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 2992
Status : Valid
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 6368-20-3
End Use API : Lacosamide
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
(R)-N-Benzyl-2-(benzyloxy carbonyl)amino-3-hydroxy...
CAS Number : 219835-31-1
End Use API : Lacosamide
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
(R)-2-((t-butoxy) carbonylamino)-3-methoxy propano...
CAS Number : 86123-95-7
End Use API : Lacosamide
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Boc-D-serine benzyl amide = (R)-N-benzyl-2-N-Boc-...
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End Use API : Lacosamide
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CAS Number : 6368-20-3
End Use API : Lacosamide
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CAS Number : 86123-95-7
End Use API : Lacosamide
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(R)-tert-Butyl 1-(benzylamino)-3-methoxy-1-oxoprop...
CAS Number : 880468-89-3
End Use API : Lacosamide
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(R)-2-amino-N-benzyl-3-methoxypropanamide
CAS Number : 196601-69-1
End Use API : Lacosamide
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 p...
CAS Number : 6081-61-4
End Use API : Lacosamide
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 p...
(R)-N-benzyl-2-(benzyloxycarbonylamino)-3-hydroxyp...
CAS Number : 219835-31-1
End Use API : Lacosamide
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : LACOSAMIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 200MG/20ML (10MG/ML)
Packaging :
Approval Date : 2024-03-25
Application Number : 217718
Regulatory Info : RX
Registration Country : USA
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
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Approval Date :
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Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
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Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
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Regulatory Info : Registered in EU
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Aucta is a global brand that creates better products from proven molecules.
Regulatory Info : RX
Registration Country : USA
Brand Name : MOTPOLY XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2023-05-04
Application Number : 216185
Regulatory Info : RX
Registration Country : USA
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AP
Brand Name : LACOSAMIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 200MG/20ML (10MG/ML)
Approval Date : 2024-03-25
Application Number : 217718
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Aucta is a global brand that creates better products from proven molecules.
RLD : Yes
TE Code :
Brand Name : MOTPOLY XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Aucta is a global brand that creates better products from proven molecules.
RLD : Yes
TE Code :
Brand Name : MOTPOLY XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 150MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Aucta is a global brand that creates better products from proven molecules.
RLD : Yes
TE Code :
Brand Name : MOTPOLY XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 200MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : LACOSAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 2022-03-17
Application Number : 205006
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : LACOSAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2022-03-17
Application Number : 204921
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : LACOSAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 204999
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code : AP
Brand Name : VIMPAT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 200MG/20ML (10MG/ML)
Approval Date : 2008-10-28
Application Number : 22254
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 22253
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PharmaCompass offers a list of Lacosamide 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 Lacosamide manufacturer or Lacosamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lacosamide manufacturer or Lacosamide supplier.
PharmaCompass also assists you with knowing the Lacosamide API Price utilized in the formulation of products. Lacosamide API Price is not always fixed or binding as the Lacosamide Price is obtained through a variety of data sources. The Lacosamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lacosamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lacosamide, including repackagers and relabelers. The FDA regulates Lacosamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lacosamide 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 Lacosamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lacosamide supplier is an individual or a company that provides Lacosamide active pharmaceutical ingredient (API) or Lacosamide finished formulations upon request. The Lacosamide suppliers may include Lacosamide API manufacturers, exporters, distributors and traders.
click here to find a list of Lacosamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lacosamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lacosamide active pharmaceutical ingredient (API) in detail. Different forms of Lacosamide DMFs exist exist since differing nations have different regulations, such as Lacosamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lacosamide DMF submitted to regulatory agencies in the US is known as a USDMF. Lacosamide USDMF includes data on Lacosamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lacosamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lacosamide 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 Lacosamide Drug Master File in Japan (Lacosamide JDMF) empowers Lacosamide 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 Lacosamide JDMF during the approval evaluation for pharmaceutical products. At the time of Lacosamide 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 Lacosamide 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 Lacosamide Drug Master File in Korea (Lacosamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lacosamide. The MFDS reviews the Lacosamide KDMF as part of the drug registration process and uses the information provided in the Lacosamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lacosamide 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 Lacosamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lacosamide suppliers with KDMF on PharmaCompass.
A Lacosamide CEP of the European Pharmacopoeia monograph is often referred to as a Lacosamide Certificate of Suitability (COS). The purpose of a Lacosamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lacosamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lacosamide to their clients by showing that a Lacosamide CEP has been issued for it. The manufacturer submits a Lacosamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lacosamide CEP holder for the record. Additionally, the data presented in the Lacosamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lacosamide DMF.
A Lacosamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lacosamide 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 Lacosamide suppliers with CEP (COS) on PharmaCompass.
A Lacosamide written confirmation (Lacosamide WC) is an official document issued by a regulatory agency to a Lacosamide manufacturer, verifying that the manufacturing facility of a Lacosamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lacosamide APIs or Lacosamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Lacosamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Lacosamide 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 Lacosamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lacosamide 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 Lacosamide 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 Lacosamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lacosamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lacosamide suppliers with NDC on PharmaCompass.
Lacosamide 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 Lacosamide 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 Lacosamide GMP manufacturer or Lacosamide GMP API supplier for your needs.
A Lacosamide CoA (Certificate of Analysis) is a formal document that attests to Lacosamide's compliance with Lacosamide specifications and serves as a tool for batch-level quality control.
Lacosamide CoA mostly includes findings from lab analyses of a specific batch. For each Lacosamide 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.
Lacosamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Lacosamide EP), Lacosamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lacosamide USP).
