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Chemistry

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Also known as: 175481-36-4, Erlosamide, Vimpat, (r)-2-acetamido-n-benzyl-3-methoxypropanamide, Harkoseride, Spm 927
Molecular Formula
C13H18N2O3
Molecular Weight
250.29  g/mol
InChI Key
VPPJLAIAVCUEMN-GFCCVEGCSA-N
FDA UNII
563KS2PQY5

Lacosamide
Lacosamide is a functionalized amino acid compound specifically synthesized as an anticonvulsive drug to use as add-on therapy for partial-onset seizures with antinociceptive and neuroprotective activities. Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels without affecting fast inactivation, thereby stabilizing hyperexcitabe neuronal membranes. Furthermore, this agent binds to collapsin response mediator protein 2 (CRMP2; DPYSL2), a cytosolic phosphoprotein expressed in most tissues. In the nervous system, CRMP2 acts as a mediator of growth cone collapse as well as modifies axon number, length, and neuronal polarity.
The physiologic effect of lacosamide is by means of Decreased Central Nervous System Disorganized Electrical Activity.
1 2D Structure

Lacosamide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-acetamido-N-benzyl-3-methoxypropanamide
2.1.2 InChI
InChI=1S/C13H18N2O3/c1-10(16)15-12(9-18-2)13(17)14-8-11-6-4-3-5-7-11/h3-7,12H,8-9H2,1-2H3,(H,14,17)(H,15,16)/t12-/m1/s1
2.1.3 InChI Key
VPPJLAIAVCUEMN-GFCCVEGCSA-N
2.1.4 Canonical SMILES
CC(=O)NC(COC)C(=O)NCC1=CC=CC=C1
2.1.5 Isomeric SMILES
CC(=O)N[C@H](COC)C(=O)NCC1=CC=CC=C1
2.2 Other Identifiers
2.2.1 UNII
563KS2PQY5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(acetylamino)-3-methoxy-n-(phenylmethyl)-, (2r)-

2. Add-234037

3. Ertosamide

4. Harkoseride

5. Spm-927

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 250.29 g/mol
Molecular Formula C13H18N2O3
XLogP30.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count6
Exact Mass250.13174244 g/mol
Monoisotopic Mass250.13174244 g/mol
Topological Polar Surface Area67.4 Ų
Heavy Atom Count18
Formal Charge0
Complexity275
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 NameVimpat
PubMed HealthLacosamide
Drug ClassesAnticonvulsant
Active IngredientLacosamide
Dosage FormTablet; Solution
RouteOral; Intravenous
Strength200mg/20ml (10mg/ml); 200mg; 150mg; 10mg/ml; 100mg; 50mg
Market StatusPrescription
CompanyUcb

2 of 2  
Drug NameVimpat
PubMed HealthLacosamide
Drug ClassesAnticonvulsant
Active IngredientLacosamide
Dosage FormTablet; Solution
RouteOral; Intravenous
Strength200mg/20ml (10mg/ml); 200mg; 150mg; 10mg/ml; 100mg; 50mg
Market StatusPrescription
CompanyUcb

4.2 Drug Indication

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


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
LACOSAMIDE
5.2.2 FDA UNII
563KS2PQY5
5.2.3 Pharmacological Classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]; Decreased Central Nervous System Disorganized Electrical Activity [PE]
5.3 ATC Code

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


5.4 Absorption, Distribution and Excretion

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


5.5 Metabolism/Metabolites

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.


5.6 Biological Half-Life

13 Hours


5.7 Mechanism of Action

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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Shandong Loncom Pharmaceutical

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Hetero Drugs Ltd

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Certificate Number : R0-CEP 2021-451 - Rev 01

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Issue Date : 2023-05-16

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Substance Number : 2992

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CEP 2023-365 - Rev 01
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Certificate Number : CEP 2023-365 - Rev 01

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Certificate Number : CEP 2020-107 - Rev 03

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Issue Date : 2024-05-02

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Substance Number : 2992

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Lacosamide

Registration Number : 306MF10100

Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, ...

Initial Date of Registration : 2024-07-17

Latest Date of Registration : 2024-07-17

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Lacosamide

Registration Number : 306MF10110

Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...

Initial Date of Registration : 2024-08-07

Latest Date of Registration : 2024-08-07

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Lacosamide

Registration Number : 306MF10102

Registrant's Address : Great Eastern Chambers, CBD Belapur, Navi Mumbai-400 614, India

Initial Date of Registration : 2024-07-17

Latest Date of Registration : 2024-07-17

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Lacosamide USP

Registration Number : 306MF10101

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2024-07-17

Latest Date of Registration : 2024-07-17

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Lacosamide

Registration Number : 306MF10075

Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

Initial Date of Registration : 2024-06-06

Latest Date of Registration : 2024-06-06

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Lacosamide

Registration Number : 306MF10107

Registrant's Address : A43 2nd Floor, Prasanthi Towers, Road No 92, Jubilee Hills, Hyderabad, Telangana 5000...

Initial Date of Registration : 2024-07-31

Latest Date of Registration : 2024-07-31

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KDMF

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lacosamide

Registrant Name : Seongwoo Chemical Co., Ltd.

Registration Date : 2016-04-29

Registration Number : Su4579-10-ND

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : Panelav, PO Tajpura, Taluka-Halol, District- Panchmahal - 389350, Gujarat State, Indi...

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lacosamide

Registrant Name : Pharmaline Co., Ltd.

Registration Date : 2021-08-20

Registration Number : Su97-1-ND

Manufacturer Name : Divi's Laboratories Ltd.

Manufacturer Address : Unit-2, 531162, Chippada Village, Annavaram, Bheemunipatnam Mandal, Visakhapatnam Dis...

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Emnar Pharma

India
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Emnar Pharma

India
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lacosamide

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, ...

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lacosamide

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2018-03-23

Registration Number : Su434-5-ND

Manufacturer Name : Jubilant Pharmova Limited

Manufacturer Address : Plot No. 18, 56, 57 & 58 KIADB Industrial Area Nanjangud - 571 302 Mysore(district), ...

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Lupin Ltd

India
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Lupin Ltd

India
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lacosamide

Registrant Name : Masung LS Co., Ltd.

Registration Date : 2019-03-20

Registration Number : Su163-17-ND

Manufacturer Name : Lupin Limited

Manufacturer Address : Block No.21, Dabhasa Taluka Padra City : Dabhasa-391-440, Dist : Vadodara, Gujarat, s...

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lacosamide

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2016-03-25

Registration Number : Su4749-16-ND(1)

Manufacturer Name : MSN Pharmachem Private Limit...

Manufacturer Address : Plot No.: 182 to 186 ,192-A, 193 to 197 & 212/ A,B,C,D, Phase-II, IDA Pashamylaram, P...

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lacosamide

Registrant Name : JLBio Co., Ltd.

Registration Date : 2025-04-21

Registration Number : Su972-1-ND

Manufacturer Name : Raghava Life Sciences Privat...

Manufacturer Address : Sy.No.888 &901, Jangampally Village, Bhiknoor Mandal, Kamareddy Dist, Pin Code: 50310...

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ST Pharma

South Korea
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ST Pharma

South Korea
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lacosamide

Registrant Name : ST Pharm Co., Ltd.

Registration Date : 2016-01-14

Registration Number : 5986-5-ND

Manufacturer Name : ST Pharm Co., Ltd.

Manufacturer Address : 231 Hyup-ro, Siheung-si, Gyeonggi-do

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09

FNCE
Not Confirmed
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lacosamide

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2024-05-29

Registration Number : Su163-19-ND(2)

Manufacturer Name : Venkata Narayana Active Ingr...

Manufacturer Address : Sy. No. 69, Chandrapadiya Village, Vinjamur Mandal, SPSR Nellore District-524228, And...

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lacosamide

Registrant Name : Hyundai Pharmaceutical Co., Ltd.

Registration Date : 2021-05-21

Registration Number : Su163-19-ND(1)

Manufacturer Name : Venkata Narayana Active Ingr...

Manufacturer Address : Sy. No. 69, Chandrapadiya Village, Vinjamur Mandal, SPSR Nellore District-524228, And...

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NDC API

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LACOSAMIDE

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

Metrochem

02

FNCE
Not Confirmed
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LACOSAMIDE

NDC Package Code : 12828-0087

Start Marketing Date : 2016-07-21

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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LACOSAMIDE

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

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04

FNCE
Not Confirmed
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LACOSAMIDE

NDC Package Code : 65977-0075

Start Marketing Date : 2008-10-28

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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05

FNCE
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LACOSAMIDE

NDC Package Code : 14445-021

Start Marketing Date : 2021-06-22

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER, FOR SOLUTION (1kg/kg)

Marketing Category : BULK INGREDIENT

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06

FNCE
Not Confirmed
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LACOSAMIDE

NDC Package Code : 65372-1186

Start Marketing Date : 2015-01-23

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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07

FNCE
Not Confirmed
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LACOSAMIDE

NDC Package Code : 50370-0024

Start Marketing Date : 2011-12-29

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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08

SIEGFRIED AG

Switzerland
FNCE
Not Confirmed
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SIEGFRIED AG

Switzerland
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FNCE
Not Confirmed

LACOSAMIDE

NDC Package Code : 17205-107

Start Marketing Date : 2010-04-20

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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09

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LACOSAMIDE

NDC Package Code : 53747-069

Start Marketing Date : 2018-03-07

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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10

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Not Confirmed
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LACOSAMIDE

NDC Package Code : 13612-0021

Start Marketing Date : 2021-01-18

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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TAMIL NADU.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642703400,"product":"LACOSAMIDE","address":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth","city":"Solapur","supplier":"GLENMARK LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"PIQ PHARMA LLC","customerCountry":"RUSSIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1000","totalValueFC":"4940","currency":"USD","unitRateINR":73600,"date":"21-Jan-2022","totalValueINR":"368000","totalValueInUsd":"4940","indian_port":"BOMBAY AIR","hs_no":"29242990","bill_no":"7646337","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth, Solapur","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642962600,"product":"OTHER-LACOSAMIDE (WE INTEND TO CLAIM REW","address":"26, VANDALUR - KELAMBAKKAM ROAD,KEELAKOTTAIYUR, KANCHIPURAM DT.,","city":"CHENNAI. 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TAMIL NADU.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643740200,"product":"LACOSAMIDE EP\/BP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"EL QAHIRA (CAIRO)","customer":"AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES","customerCountry":"EGYPT","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"400.7","totalValueFC":"7081.2","currency":"USD","unitRateINR":29488.055555555555,"date":"02-Feb-2022","totalValueINR":"530785","totalValueInUsd":"7081.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29224990","bill_no":"4000072","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643740200,"product":"LACOSAMIDE EP\/BP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"EL QAHIRA (CAIRO)","customer":"AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES","customerCountry":"EGYPT","quantity":"21.00","actualQuantity":"21","unit":"KGS","unitRateFc":"364.8","totalValueFC":"7522.6","currency":"USD","unitRateINR":26851,"date":"02-Feb-2022","totalValueINR":"563871","totalValueInUsd":"7522.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29224990","bill_no":"4000072","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643826600,"product":"OTHER - LACOSAMIDE (WE INTEND TO CLAIM R","address":"26, VANDALUR - KELAMBAKKAM ROAD,KEELAKOTTAIYUR, KANCHIPURAM DT.,","city":"CHENNAI. 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C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN PHARMACHEM PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"LOUISVILLE, KY","customer":"CATALENT PHARMA SOLUTIONS","customerCountry":"UNITED STATES","quantity":"430.00","actualQuantity":"430","unit":"KGS","unitRateFc":"675","totalValueFC":"286738.1","currency":"USD","unitRateINR":49983.720930232557,"date":"05-Feb-2022","totalValueINR":"21493000","totalValueInUsd":"286738.1","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"8000218","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. 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08-Jan-2022
29-Aug-2025
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Drugs in Development

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Details:

Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Motpoly XR

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2024

Aucta Company Banner

01

Lead Product(s) : Lacosamide,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.

Product Name : Motpoly XR

Product Type : Controlled Substance

Upfront Cash : Inapplicable

February 26, 2024

Aucta Company Banner

Details:

Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Lacosamide-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 22, 2022

Tiefenbacher Compnay Banner

02

Lead Product(s) : Lacosamide,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain.

Product Name : Lacosamide-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 22, 2022

Tiefenbacher Compnay Banner

Details:

Vimpat-Generic (lacosamide) is a sodium channel alpha subunit blocker, which is being evaluated for the treatment of primary generalized tonic-clonic seizures.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Vimpat-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 16, 2024

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03

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Details : Vimpat-Generic (lacosamide) is a sodium channel alpha subunit blocker, which is being evaluated for the treatment of primary generalized tonic-clonic seizures.

Product Name : Vimpat-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 16, 2024

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  • Development Update

Details:

Lorazepam is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Coma.


Lead Product(s): Lorazepam,Midazolam,Diazepam,Levetiracetam,Divalproex Sodium,Lacosamide

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Controlled Substance

Sponsor: Hôpital Universitaire de Bruxelles | ZonMw | Belgium Health Care Knowledge Centre

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 12, 2024

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04

University of Twente

Country
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Aquaexpo
Not Confirmed

University of Twente

Country
arrow
Aquaexpo
Not Confirmed

Lead Product(s) : Lorazepam,Midazolam,Diazepam,Levetiracetam,Divalproex Sodium,Lacosamide

Therapeutic Area : Neurology

Highest Development Status : Undisclosed

Partner/Sponsor/Collaborator : Hôpital Universitaire de Bruxelles | ZonMw | Belgium Health Care Knowledge Centre

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Lorazepam is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Coma.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

August 12, 2024

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Details:

Lacosamide is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Controlled Substance

Sponsor: Beijing Capton Pharmaceutical Technology Development

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 28, 2023

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05

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Lead Product(s) : Lacosamide,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Beijing Capton Pharmaceutical Technology Development

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Lacosamide is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 28, 2023

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Details:

Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels and possibly interacts with collapsin response mediator protein-2. It is indicated for treating partial onset seizures.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Vimpat-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 09, 2023

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06

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Details : Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels and possibly interacts with collapsin response mediator protein-2. It is indicated for treating partial onset seizures.

Product Name : Vimpat-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 09, 2023

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Details:

Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Lacosamide-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 15, 2022

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07

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Details : Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.

Product Name : Lacosamide-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 15, 2022

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Details:

Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Lacosamide-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Breckenridge Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 19, 2022

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08

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Details : Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.

Product Name : Lacosamide-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 19, 2022

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Details:

The approval granted by U.S.FDA for ANDA of Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg, a generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg will be used for prevention and control of seizures.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Vimpat-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 21, 2022

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09

Aquaexpo
Not Confirmed
Aquaexpo
Not Confirmed

Details : The approval granted by U.S.FDA for ANDA of Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg, a generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg will be used for prevention and control of seizures.

Product Name : Vimpat-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 21, 2022

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Details:

The PGTCS approval is based, in part, on results of a Phase 3 study. All three VIMPAT formulations, intravenous injections, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients aged 4 and above.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Vimpat

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 17, 2020

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10

UCB Pharma S.A

Belgium
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Aquaexpo
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UCB Pharma S.A

Belgium
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Aquaexpo
Not Confirmed

Details : The PGTCS approval is based, in part, on results of a Phase 3 study. All three VIMPAT formulations, intravenous injections, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients aged...

Product Name : Vimpat

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 17, 2020

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Regulatory Info : RX

Registration Country : USA

LACOSAMIDE

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

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Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Lacosamide

Brand Name :

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Dosage Strength : 100MG

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Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Registration Country : Germany

Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Regulatory Info : Registered in EU

Registration Country : Germany

Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Regulatory Info : Registered in EU

Registration Country : Germany

Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Regulatory Info : Registered in EU

Registration Country : Germany

Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Lacosamide

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

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Regulatory Info : RX

Registration Country : USA

LACOSAMIDE

Brand Name : MOTPOLY XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2023-05-04

Application Number : 216185

Regulatory Info : RX

Registration Country : USA

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DR REDDYS

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RLD : No

TE Code : AP

LACOSAMIDE

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

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RLD : Yes

TE Code :

LACOSAMIDE

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 :

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TE Code :

LACOSAMIDE

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 :

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TE Code :

LACOSAMIDE

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 :

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ACCORD HLTHCARE

United Kingdom
FNCE
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
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FNCE
Not Confirmed

LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Approval Date : 2022-07-12

Application Number : 205011

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2022-03-31

Application Number : 214695

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 10MG/ML

Approval Date : 2024-03-27

Application Number : 204839

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2023-01-05

Application Number : 204994

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

INDOCO

India
FNCE
Not Confirmed
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INDOCO

India
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FNCE
Not Confirmed

LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 200MG/20ML (10MG/ML)

Approval Date : 2022-04-07

Application Number : 214301

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2022-03-17

Application Number : 204921

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Canada

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ACCORD HEALTHCARE INC

United Kingdom
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ACCORD HEALTHCARE INC

United Kingdom
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FNCE
Not Confirmed

LACOSAMIDE

Brand Name : ACH-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2489317

Regulatory Info : Prescription

Registration Country : Canada

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02

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : AG-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 2501937

Regulatory Info : Prescription

Registration Country : Canada

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03

FNCE
Not Confirmed
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LACOSAMIDE

Brand Name : AURO-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 14/60/100/500

Approval Date :

Application Number : 2475340

Regulatory Info : Prescription

Registration Country : Canada

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04

FNCE
Not Confirmed
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LACOSAMIDE

Brand Name : JAMP-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 2488388

Regulatory Info : Prescription

Registration Country : Canada

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05

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : MINT-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 2490560

Regulatory Info : Prescription

Registration Country : Canada

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06

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : PHARMA-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 60

Approval Date :

Application Number : 2478218

Regulatory Info : Prescription

Registration Country : Canada

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07

FNCE
Not Confirmed
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FNCE
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LACOSAMIDE

Brand Name : SANDOZ LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging : 60

Approval Date :

Application Number : 2474697

Regulatory Info : Prescription

Registration Country : Canada

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08

FNCE
Not Confirmed
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LACOSAMIDE

Brand Name : LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 2512890

Regulatory Info : Prescription

Registration Country : Canada

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09

FNCE
Not Confirmed
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LACOSAMIDE

Brand Name : TEVA-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging : 60

Approval Date :

Application Number : 2472902

Regulatory Info : Prescription

Registration Country : Canada

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10

FNCE
Not Confirmed
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LACOSAMIDE

Brand Name : TEVA-LACOSAMIDE

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 60

Approval Date :

Application Number : 2472937

Regulatory Info : Prescription

Registration Country : Canada

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DOSAGE - TABLET;ORAL - 100MG

USFDA APPLICATION NUMBER - 22253

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DOSAGE - TABLET;ORAL - 150MG

USFDA APPLICATION NUMBER - 22253

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 22253

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 12042474

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3660

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 11337943

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 11883374

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3660

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 12042474

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 11337943

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 12042474

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 11337943

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 12042474

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3954

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 12042474

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3660

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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AUCTA

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Patent Expiration Date : 2040-06-05

LACOSAMIDE

US Patent Number : 11883374

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216185

Patent Use Code : U-3660

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-06-05

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REF. STANDARDS & IMPURITIES

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N-Methyl rac-Lacosamide

CAS Number : 388619-64-5

Quantity Per Vial :

Price ($) : 450

Catalog Number : 1A02310

Current Lot : 25 mg

Previous Lot :

NDC Code :

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Ureidolacosamide

CAS Number : 2295925-90-3

Quantity Per Vial :

Price ($) : 1900

Catalog Number : 1A01820

Current Lot : 25 mg

Previous Lot :

NDC Code :

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Virtual BoothUSP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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N-Benzylacetamide (N-Acetylbenzylamine)

CAS Number : 588-46-5

Quantity Per Vial :

Price ($) : 700

Catalog Number : 1A01810

Current Lot : 25 mg

Previous Lot :

NDC Code :

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Lacosamide Acrylamide Analog

CAS Number : 86921-49-5

Quantity Per Vial :

Price ($) : 700

Catalog Number : 1A01800

Current Lot : 25 mg

Previous Lot :

NDC Code :

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N-Methyl Lacosamide

CAS Number : 2742962-60-1

Quantity Per Vial :

Price ($) : 2000

Catalog Number : 1A01790

Current Lot : 25 mg

Previous Lot :

NDC Code :

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ABOUT THIS PAGE

Looking for 175481-36-4 / Lacosamide API manufacturers, exporters & distributors?

Lacosamide manufacturers, exporters & distributors 1

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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.

API | Excipient name

Lacosamide

Synonyms

175481-36-4, Erlosamide, Vimpat, (r)-2-acetamido-n-benzyl-3-methoxypropanamide, Harkoseride, Spm 927

Cas Number

175481-36-4

Unique Ingredient Identifier (UNII)

563KS2PQY5

About Lacosamide

Lacosamide is a functionalized amino acid compound specifically synthesized as an anticonvulsive drug to use as add-on therapy for partial-onset seizures with antinociceptive and neuroprotective activities. Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels without affecting fast inactivation, thereby stabilizing hyperexcitabe neuronal membranes. Furthermore, this agent binds to collapsin response mediator protein 2 (CRMP2; DPYSL2), a cytosolic phosphoprotein expressed in most tissues. In the nervous system, CRMP2 acts as a mediator of growth cone collapse as well as modifies axon number, length, and neuronal polarity.

Lacosamide Manufacturers

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.

Lacosamide Suppliers

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.

Lacosamide USDMF

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.

Lacosamide 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 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.

Lacosamide KDMF

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.

Lacosamide CEP

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.

Lacosamide WC

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.

Lacosamide 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 Lacosamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lacosamide 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 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.

Compounded drug products

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 GMP

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.

Lacosamide CoA

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).

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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