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    Chemistry

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    Also known as: 357336-20-0, Briviact, Ucb-34714, Ucb 34714, Ucb34714, 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide
    Molecular Formula
    C11H20N2O2
    Molecular Weight
    212.29  g/mol
    InChI Key
    MSYKRHVOOPPJKU-BDAKNGLRSA-N
    FDA UNII
    U863JGG2IA
    Brivaracetam
    Brivaracetam is an orally bioavailable levetiracetam derivative, with anticonvulsant activity. Although the exact mechanism through which brivaracetam exerts its effects is not fully known, this agent targets and binds to synaptic vesicle protein 2A (SV2A) in the brain. This prevents synaptic vesicle exocytosis and the synaptic release of certain, as of yet not fully known, excitatory neurotransmitters. This may inhibit impulse conduction across synapses, decrease neuronal (hyper-)excitability, and may modulate epileptogenesis. SV2A, a membrane glycoprotein present in neuronal synaptic vesicles, plays a key role in action potential-induced neurotransmitter release in the brain.
    The mechanism of action of brivaracetam is as an Epoxide Hydrolase Inhibitor.
    1 2D Structure

    Brivaracetam

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide
    2.1.2 InChI
    InChI=1S/C11H20N2O2/c1-3-5-8-6-10(14)13(7-8)9(4-2)11(12)15/h8-9H,3-7H2,1-2H3,(H2,12,15)/t8-,9+/m1/s1
    2.1.3 InChI Key
    MSYKRHVOOPPJKU-BDAKNGLRSA-N
    2.1.4 Canonical SMILES
    CCCC1CC(=O)N(C1)C(CC)C(=O)N
    2.1.5 Isomeric SMILES
    CCC[C@@H]1CC(=O)N(C1)[C@@H](CC)C(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    U863JGG2IA
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (2s)-2-((4r)-2-oxo-4-propylpyrrolidin-1-yl)butanamide

    2. 1-pyrrolidineacetamide, Alpha-ethyl-2-oxo-4-propyl-, (alphas,4r)-

    3. 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide

    4. Briviact

    5. Ucb 34714

    6. Ucb-34714

    7. Ucb34714

    2.3.2 Depositor-Supplied Synonyms

    1. 357336-20-0

    2. Briviact

    3. Ucb-34714

    4. Ucb 34714

    5. Ucb34714

    6. 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide

    7. (2s)-2-[(4r)-2-oxo-4-propylpyrrolidin-1-yl]butanamide

    8. (2s)-2-((4r)-2-oxo-4-propylpyrrolidin-1-yl)butanamide

    9. U863jgg2ia

    10. Rikelta

    11. Brivaracetam [usan:inn]

    12. Unii-u863jgg2ia

    13. Compound 83alpha

    14. 1-pyrrolidineacetamide, Alpha-ethyl-2-oxo-4-propyl-, (alphas,4r)-

    15. Brivaracetam 97%

    16. Briviact (tn)

    17. Brivaracetam [mi]

    18. Brivaracetam [inn]

    19. Brivaracetam [jan]

    20. Brivaracetam [usan]

    21. Brivaracetam [mart.]

    22. Brivaracetam [who-dd]

    23. Schembl122081

    24. Brivaracetam (jan/usan/inn)

    25. Chembl607400

    26. Gtpl9041

    27. Dtxsid00905081

    28. Chebi:133013

    29. Brivaracetam [orange Book]

    30. Ex-a2748

    31. Zinc3979899

    32. Bdbm50422531

    33. Mfcd25976668

    34. Akos027324306

    35. Ccg-266666

    36. Cs-3418

    37. Db05541

    38. Ncgc00390779-02

    39. Ac-29289

    40. As-35277

    41. Bb161996

    42. Hy-14449

    43. D08879

    44. Q408099

    45. (s)-2-((r)-2-oxo-4-propylpyrrolidin-1-yl)butanamide

    46. (2s)-2-((4r)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide

    47. (2s)-2-((4r)-2-oxo-4-propyltetrahydro-1h-pyrrol-1-yl) Butanamide

    48. 1-pyrrolidineacetamide, .alpha.-ethyl-2-oxo-4-propyl (.alpha.s,4r)-

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 212.29 g/mol
    Molecular Formula C11H20N2O2
    XLogP31
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count5
    Exact Mass212.152477885 g/mol
    Monoisotopic Mass212.152477885 g/mol
    Topological Polar Surface Area63.4 Ų
    Heavy Atom Count15
    Formal Charge0
    Complexity253
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Used as adjunctive therapy for partial-onset seizures in patients 16 years of age or older.

    FDA Label

    Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.

    Treatment of epilepsy with partial-onset seizures, Treatment of neonatal seizures

    Treatment of neonatal seizures, Treatment of paediatric epilepsy syndromes

    Treatment of epilepsy with partial-onset seizures

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action.

    5.2 MeSH Pharmacological Classification

    Anticonvulsants

    Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    BRIVARACETAM
    5.3.2 FDA UNII
    U863JGG2IA
    5.3.3 Pharmacological Classes
    Epoxide Hydrolase Inhibitors [MoA]
    5.4 ATC Code

    N03AX23

    N03AX23

    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

    N03AX23 - Brivaracetam

    5.5 Absorption, Distribution and Excretion

    Absorption

    Nearly 100% oral bioavailability.

    Route of Elimination

    \>95% excreted in urine with <10% of the parent compound unchanged. <1% excreted in feces.

    Volume of Distribution

    0.5L/kg.

    Clearance

    CL/F of 0.7-1.07 mL/min kg. Clearance is primarily metabolic with less than 10% of the parent drug excreted unchanged.

    5.6 Metabolism/Metabolites

    Primarily metabolized by hydrolysis of the acetamide moeity to form a carboxylic acid metabolite. Another metabolite is created via oxidation of the propyl side chain by CYP2C8 as well as CYP3A4, CYP2C19, and CYP2B6. Some conjugation with glucuronic acid and taurine account for a small amount of metabolism.

    5.7 Biological Half-Life

    7-8h.

    5.8 Mechanism of Action

    The precise mechanism of brivaracetam's anti-epileptogenic activity is unknown.

    API Reference Price

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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"BRIVARACETAM IH (TAX INV NO.F22512900018DT.23.04.25) (GST NO.29AAWCS7320Q1Z8)","address":"SHED NO F-1, IDA, ROAD NO.6","city":"KUKATPALLY","supplier":"VIRUJ CHEMATRIX PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BAGDAD, METROPOLITAN","customer":"SAMA AL FAYHAA PHARMACEUTICAL INDUS","customerCountry":"IRAQ","quantity":"188.00","actualQuantity":"188","unit":"KGS","unitRateFc":"1900","totalValueFC":"353291","currency":"USD","unitRateINR":160863.51063829788,"date":"29-Apr-2025","totalValueINR":"30242340","totalValueInUsd":"353291","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1370730","productDescription":"API","marketType":"","country":"IRAQ","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SHED NO F-1, IDA, ROAD NO.6, KUKATPALLY","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679769000,"product":"BRIVARACETAM (REIMPORT CARGO EXPORTED VIDE SHIPPING BILL NO.9859860 DT. 21.04.2022)","address":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. 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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1400","totalValueFC":"3523.4","currency":"USD","unitRateINR":"293300","date":"28-Dec-2023","totalValueINR":"293300","totalValueInUsd":"3523.4","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"9443792","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO , LINHAI ZHEJIANG 317024 CHINA Zhenjiang, , ChinaSDNF China","customerAddress":"159, C.S.T. 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CHI China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737916200,"product":"BRIVARACETAM (RE-IMPORT MATERIAL VIDE SB NO-4000159 DT:19.02.2024, RID NO-252400672300)","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"XXMJIXXPHAXXACEXXICAXXCO XXD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"INCHEON","customer":"HONOUR LAB LIMITED","customerCountry":"INDIA","quantity":"41.00","actualQuantity":"41","unit":"KGS","unitRateFc":"2807.7","totalValueFC":"116277.6","currency":"USD","unitRateINR":"244549.3","date":"27-Jan-2025","totalValueINR":"10026521","totalValueInUsd":"116277.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29242990","bill_no":"1000048","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC O","selfForZScoreResived":"Pharma Grade","supplierPort":"INCHEON","supplierAddress":"N\/A","customerAddress":"8-3-166\/7\/1, HETERO HOUSE,"}]
    31-Jan-2022
    29-Apr-2025
    KGS
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    Drugs in Development

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    UCB Announces Positive Preliminary Results For Major Brivaracetam (Briviact[®]) Study In Asia

    Details:

    Positive topline results from a Phase 3 study investigating the efficacy and safety of adjunctive brivaracetam in participants across Asia (≥16 to 80 years of age) with partial seizures with or without secondary generalization.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 10, 2022

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    01

    UCB Pharma S.A

    Belgium
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    UCB Pharma S.A

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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    UCB Announces Positive Preliminary Results For Major Brivaracetam (Briviact[®]) Study In Asia

    Details : Positive topline results from a Phase 3 study investigating the efficacy and safety of adjunctive brivaracetam in participants across Asia (≥16 to 80 years of age) with partial seizures with or without secondary generalization.

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    October 10, 2022

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    UCB Receives Positive CHMP Opinion Recommending Approval of BRIVIACT[®] (brivaracetam) and VIMPAT[®] (lacosamide) in the EU for Partial-Onset Seizures...

    Details:

    With these positive CHMP opinions, BRIVIACT® (brivaracetam) and VIMPAT® (lacosamide) will provide young patients and their caregivers with additional treatment options for POS with or without secondary generalization.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 02, 2022

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    02

    UCB Pharma S.A

    Belgium
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    UCB Pharma S.A

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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    UCB Receives Positive CHMP Opinion Recommending Approval of BRIVIACT[®] (brivaracetam) and VIMPAT...

    Details : With these positive CHMP opinions, BRIVIACT® (brivaracetam) and VIMPAT® (lacosamide) will provide young patients and their caregivers with additional treatment options for POS with or without secondary generalization.

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    February 02, 2022

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    UCB to present data at the American Epilepsy Society 76th Annual Meeting 2022 supporting a decades-long commitment to transforming epilepsy care

    Details:

    Brecita (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 12, 2022

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    03

    UCB Pharma S.A

    Belgium
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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    UCB to present data at the American Epilepsy Society 76th Annual Meeting 2022 supporting a decades...

    Details : Brecita (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    January 12, 2022

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    UCB Showcases Strength of Broad Neurology Portfolio at 74th American Academy of Neurology (AAN) Annual Meeting

    Details:

    BRIVIACT (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 04, 2022

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    UCB Pharma S.A

    Belgium
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    Not Confirmed

    UCB Pharma S.A

    Belgium
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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    UCB Showcases Strength of Broad Neurology Portfolio at 74th American Academy of Neurology (AAN) An...

    Details : BRIVIACT (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    January 04, 2022

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    Lupin Receives Tentative U.S. FDA Approval for Brivaracetam Tablets

    Details:

    Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brivaracetam-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 16, 2021

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    Lupin Ltd

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    Not Confirmed

    Lupin Ltd

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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin Receives Tentative U.S. FDA Approval for Brivaracetam Tablets

    Details : Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.

    Product Name : Brivaracetam-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 16, 2021

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    Natco Pharma Launches Epilepsy Treatment Drug Brivaracetam in India

    Details:

    Natco Pharma has launched Brivaracetam tablets under brand BRECITA in India. Brivaracetam, indicated towards the treatment of epilepsy, is developed by UCB Pharma and currently marketed in India by Dr Reddy's under the brand name Briviact.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 26, 2021

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    Natco Pharma

    India
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    Natco Pharma

    India
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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Natco Pharma Launches Epilepsy Treatment Drug Brivaracetam in India

    Details : Natco Pharma has launched Brivaracetam tablets under brand BRECITA in India. Brivaracetam, indicated towards the treatment of epilepsy, is developed by UCB Pharma and currently marketed in India by Dr Reddy's under the brand name Briviact.

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    February 26, 2021

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    UCB Demonstrates Commitment to Science and Discovery Across Its Epilepsy Portfolio at the American Epilepsy Society's Virtual Event AES2020

    Details:

    15 scientific presentations highlight data on BRIVACT® (brivaracetam) CV, NAYZILAM® (midazolam) nasal spray CIV, VIMPAT® (lacosamide) CV, and others, illustrating UCB's commitment to developing new treatment options for patients in their treatment journey.


    Lead Product(s): Brivaracetam

    Therapeutic Area: Neurology Brand Name: Brecita

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 12, 2020

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    UCB Pharma S.A

    Belgium
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    IMCAS Asia
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    Belgium
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    Lead Product(s) : Brivaracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    UCB Demonstrates Commitment to Science and Discovery Across Its Epilepsy Portfolio at the American...

    Details : 15 scientific presentations highlight data on BRIVACT® (brivaracetam) CV, NAYZILAM® (midazolam) nasal spray CIV, VIMPAT® (lacosamide) CV, and others, illustrating UCB's commitment to developing new treatment options for patients in their treatment jou...

    Product Name : Brecita

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    April 12, 2020

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    INTERMEDIATE SUPPLIERS

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    01

    Shanghai Minbiotech

    China
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    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

    (+)-(R)-4-propyl-4,5- dihydrofuran-2(3H)-one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

    Shanghai Minbiotech CB

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    02

    Aozeal Certified Standards

    U.S.A
    IMCAS Asia
    Not Confirmed
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    Aozeal Certified Standards

    U.S.A
    IMCAS Asia
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    Brivaracetam Intermediate

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : We are CDMO engaged in drug impurities research, customed synthesis for almost 10 years. In addition, we establish a long-term in-depth partnerships with many w...

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    03

    Aptra Synthesis

    India
    IMCAS Asia
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    Aptra Synthesis

    India
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    (R)-4-PropyIdihydrofuran-2(3H)-one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

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    04

    Cangzhou Senary Chemical Science-te...

    China
    IMCAS Asia
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    Cangzhou Senary Chemical Science-te...

    China
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    (S)-2-Aminobutanamide hydrochloride

    CAS Number : 7682-20-4

    End Use API : Brivaracetam

    About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

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    05

    Dalian Richon Chem

    China
    IMCAS Asia
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    China
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    (+)-(R)-4-propyl-4,5-dihydrofuran-2(3H)-one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceu...

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    06

    Enzymaster (Ningbo) Bio-Engineering

    China
    IMCAS Asia
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    China
    IMCAS Asia
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    R)-4-Propyldihydrofuran-2(3H)-one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : Based on the excellent enzymatic technology platform, Enzymaster Chemical applies innovative technology to realize its commercial production of chiral compounds...

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    07

    Epoch Labs

    India
    IMCAS Asia
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    Epoch Labs

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    (R)-4-propyl dihydro furan-2(3H) one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizat...

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    08

    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
    Not Confirmed
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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
    Not Confirmed
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    (R)-4-Propyldihydrofuran-2(3H)-one

    CAS Number : 63095-51-2

    End Use API : Brivaracetam

    About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
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    (R)-2-Aminobutanamide Hydrochloride

    CAS Number : 103765-03-3

    End Use API : Brivaracetam

    About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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    10

    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
    IMCAS Asia
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    alpha-ethyl-2,5-dihydro-2-oxo-4-propyl-(aS)-1H-Pyr...

    CAS Number : 357338-13-7

    End Use API : Brivaracetam

    About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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    FDF Dossiers

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    01

    Apotex Inc

    Canada
    IMCAS Asia
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    Apotex Inc

    Canada
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    Regulatory Info :

    Registration Country : USA

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG

    Packaging :

    Approval Date :

    Application Number : 214875

    Regulatory Info :

    Registration Country : USA

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    Apotex Inc

    Canada
    IMCAS Asia
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    Apotex Inc

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : APO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2538717

    Regulatory Info : Prescription

    Registration Country : Canada

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    03

    Ascent Innovative Medicines

    India
    IMCAS Asia
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    Ascent Innovative Medicines

    India
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    Regulatory Info :

    Registration Country : India

    brivaracetam

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Aurobindo Pharma Limited

    India
    IMCAS Asia
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    India
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    Regulatory Info : DISCN

    Registration Country : USA

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2023-01-06

    Application Number : 214848

    Regulatory Info : DISCN

    Registration Country : USA

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    MSN Laboratories

    India
    IMCAS Asia
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    Regulatory Info :

    Registration Country : USA

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Packaging :

    Approval Date :

    Application Number : 214921

    Regulatory Info :

    Registration Country : USA

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    MSN Laboratories

    India
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    Regulatory Info :

    Registration Country : USA

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 50MG/5ML (10MG/ML)

    Packaging :

    Approval Date :

    Application Number : 214924

    Regulatory Info :

    Registration Country : USA

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    UCB Pharma S.A

    Belgium
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    Belgium
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    Regulatory Info :

    Registration Country : Norway

    brivaracetam

    Brand Name : Briviact

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 75 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    UCB Pharma S.A

    Belgium
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : BRIVLERA

    Dosage Form : TABLET

    Dosage Strength : 25MG

    Packaging : 1/14/60

    Approval Date :

    Application Number : 2452944

    Regulatory Info : Prescription

    Registration Country : Canada

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    UCB Pharma S.A

    Belgium
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    Regulatory Info :

    Registration Country : Australia

    Brivaracetam

    Brand Name : Briviact

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    UCB Pharma S.A

    Belgium
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    Regulatory Info :

    Registration Country : Australia

    Brivaracetam

    Brand Name : Briviact

    Dosage Form :

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    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    APOTEX INC

    Canada
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    RLD :

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date :

    Application Number : 214875

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    APOTEX INC

    Canada
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    RLD :

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG

    Approval Date :

    Application Number : 214875

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    AUROBINDO PHARMA LTD

    India
    IMCAS Asia
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    RLD : No

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 2023-01-06

    Application Number : 214848

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    LUPIN LTD

    India
    IMCAS Asia
    Not Confirmed
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    LUPIN LTD

    India
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    IMCAS Asia
    Not Confirmed
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    RLD : No

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2022-12-20

    Application Number : 214918

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    MSN LABORATORIES PRIVATE LTD

    India
    IMCAS Asia
    Not Confirmed
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    MSN LABORATORIES PRIVATE LTD

    India
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    IMCAS Asia
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    RLD :

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date :

    Application Number : 214921

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    MSN LABORATORIES PRIVATE LTD

    India
    IMCAS Asia
    Not Confirmed
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    MSN LABORATORIES PRIVATE LTD

    India
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    IMCAS Asia
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    RLD :

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date :

    Application Number : 214921

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    SUNSHINE

    China
    IMCAS Asia
    Not Confirmed
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    SUNSHINE

    China
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    IMCAS Asia
    Not Confirmed
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    RLD : No

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date : 2022-06-09

    Application Number : 214748

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    08

    SUNSHINE

    China
    IMCAS Asia
    Not Confirmed
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    SUNSHINE

    China
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    IMCAS Asia
    Not Confirmed
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    RLD : No

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 2022-06-09

    Application Number : 214748

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    SUNSHINE

    China
    IMCAS Asia
    Not Confirmed
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    SUNSHINE

    China
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    IMCAS Asia
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVARACETAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG

    Approval Date : 2022-06-09

    Application Number : 214748

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    UCB INC

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB INC

    Belgium
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    IMCAS Asia
    Not Confirmed
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    RLD : Yes

    TE Code :

    BRIVARACETAM

    Brand Name : BRIVIACT

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 10MG/ML

    Approval Date : 2016-05-12

    Application Number : 205838

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Europe

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    01

    2care4 ApS

    Denmark
    IMCAS Asia
    Not Confirmed
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    2care4 ApS

    Denmark
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    IMCAS Asia
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Norway

    Brivaracetam

    Brand Name : Briviact

    Dosage Form : Tablet, film-coated

    Dosage Strength : 50 mg

    Packaging : Blisterpakning 56item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    UCB Pharma SA,

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA,

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Flag Belgium
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    brivaracetam

    Brand Name : Briviact

    Dosage Form : INJECTION / INFUSION

    Dosage Strength : 10 MG / ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    03

    UCB Pharma SA,

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA,

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    brivaracetam

    Brand Name : Briviact

    Dosage Form : ORAL SOLUTION

    Dosage Strength : 10 MG / ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    04

    UCB Pharma SA,

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA,

    Belgium
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    IMCAS Asia
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Sweden

    brivaracetam

    Brand Name : Briviact

    Dosage Form : FILM COATED PILL

    Dosage Strength : 100 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    05

    UCB Pharma Said

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma Said

    Belgium
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    IMCAS Asia
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Norway

    brivaracetam

    Brand Name : Briviact

    Dosage Form : Injection/infusion fluid, resolution

    Dosage Strength : 10 mg/ml

    Packaging : Hood glass

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    UCB Pharma Said

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma Said

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    brivaracetam

    Brand Name : Briviact

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 100 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    UCB Pharma SA

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA

    Belgium
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    IMCAS Asia
    Not Confirmed
    • fda
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    Flag Belgium
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    Regulatory Info :

    Registration Country : Norway

    Brivaracetam

    Brand Name : Briviact

    Dosage Form : Tablet, film-coated

    Dosage Strength : 100 mg

    Packaging : Blisterpakning 56item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    08

    UCB Pharma SA

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA

    Belgium
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    IMCAS Asia
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Norway

    Brivaracetam

    Brand Name : Briviact

    Dosage Form : Solution for injection/infusion

    Dosage Strength : 10 mg/ml

    Packaging : Vials 10 5ml

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    09

    UCB Pharma SA

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB Pharma SA

    Belgium
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    IMCAS Asia
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Norway

    Brivaracetam

    Brand Name : Briviact

    Dosage Form : Tablet, film-coated

    Dosage Strength : 50 mg

    Packaging : Blisterpakning 56item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    10

    UCB-Pharma SA

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB-Pharma SA

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Flag Belgium
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    Regulatory Info :

    Registration Country : Switzerland

    Brivaracetam

    Brand Name : Briviact

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Canada

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    01

    APOTEX INC

    Canada
    IMCAS Asia
    Not Confirmed
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    APOTEX INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Flag Canada
    Virtual Booth Virtual Booth
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : APO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number : 2538679

    Regulatory Info : Prescription

    Registration Country : Canada

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    02

    APOTEX INC

    Canada
    IMCAS Asia
    Not Confirmed
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    APOTEX INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : APO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number : 2538695

    Regulatory Info : Prescription

    Registration Country : Canada

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    03

    APOTEX INC

    Canada
    IMCAS Asia
    Not Confirmed
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    APOTEX INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : APO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 75MG

    Packaging :

    Approval Date :

    Application Number : 2538709

    Regulatory Info : Prescription

    Registration Country : Canada

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    04

    APOTEX INC

    Canada
    IMCAS Asia
    Not Confirmed
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    APOTEX INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : APO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2538717

    Regulatory Info : Prescription

    Registration Country : Canada

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    05

    AURO PHARMA INC

    Canada
    IMCAS Asia
    Not Confirmed
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    AURO PHARMA INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : AURO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number : 2539292

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    AURO PHARMA INC

    Canada
    IMCAS Asia
    Not Confirmed
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    AURO PHARMA INC

    Canada
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : AURO-BRIVARACETAM

    Dosage Form : TABLET

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2539306

    Regulatory Info : Prescription

    Registration Country : Canada

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    07

    UCB CANADA INC

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB CANADA INC

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : BRIVLERA

    Dosage Form : TABLET

    Dosage Strength : 10MG

    Packaging : 1/14/60

    Approval Date :

    Application Number : 2452936

    Regulatory Info : Prescription

    Registration Country : Canada

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    08

    UCB CANADA INC

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB CANADA INC

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Registration Country : Canada

    BRIVARACETAM

    Brand Name : BRIVLERA

    Dosage Form : TABLET

    Dosage Strength : 50MG

    Packaging : 1/14/60

    Approval Date :

    Application Number : 2452952

    Regulatory Info : Prescription

    Registration Country : Canada

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    09

    UCB CANADA INC

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB CANADA INC

    Belgium
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    IMCAS Asia
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : BRIVLERA

    Dosage Form : TABLET

    Dosage Strength : 75MG

    Packaging : 1/14/60

    Approval Date :

    Application Number : 2452960

    Regulatory Info : Prescription

    Registration Country : Canada

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    10

    UCB CANADA INC

    Belgium
    IMCAS Asia
    Not Confirmed
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    UCB CANADA INC

    Belgium
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    IMCAS Asia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Canada

    BRIVARACETAM

    Brand Name : BRIVLERA

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 300ML

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    Application Number : 2452987

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    ABOUT THIS PAGE

    Looking for 357336-20-0 / Brivaracetam API manufacturers, exporters & distributors?

    Brivaracetam manufacturers, exporters & distributors 1

    23

    PharmaCompass offers a list of Brivaracetam 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 Brivaracetam manufacturer or Brivaracetam supplier for your needs.

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

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

    API | Excipient name

    Brivaracetam

    Synonyms

    357336-20-0, Briviact, Ucb-34714, Ucb 34714, Ucb34714, 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide

    Cas Number

    357336-20-0

    Unique Ingredient Identifier (UNII)

    U863JGG2IA

    About Brivaracetam

    Brivaracetam is an orally bioavailable levetiracetam derivative, with anticonvulsant activity. Although the exact mechanism through which brivaracetam exerts its effects is not fully known, this agent targets and binds to synaptic vesicle protein 2A (SV2A) in the brain. This prevents synaptic vesicle exocytosis and the synaptic release of certain, as of yet not fully known, excitatory neurotransmitters. This may inhibit impulse conduction across synapses, decrease neuronal (hyper-)excitability, and may modulate epileptogenesis. SV2A, a membrane glycoprotein present in neuronal synaptic vesicles, plays a key role in action potential-induced neurotransmitter release in the brain.

    357336-20-0 Manufacturers

    A 357336-20-0 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 357336-20-0, including repackagers and relabelers. The FDA regulates 357336-20-0 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 357336-20-0 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 357336-20-0 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    357336-20-0 Suppliers

    A 357336-20-0 supplier is an individual or a company that provides 357336-20-0 active pharmaceutical ingredient (API) or 357336-20-0 finished formulations upon request. The 357336-20-0 suppliers may include 357336-20-0 API manufacturers, exporters, distributors and traders.

    click here to find a list of 357336-20-0 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    357336-20-0 USDMF

    A 357336-20-0 DMF (Drug Master File) is a document detailing the whole manufacturing process of 357336-20-0 active pharmaceutical ingredient (API) in detail. Different forms of 357336-20-0 DMFs exist exist since differing nations have different regulations, such as 357336-20-0 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A 357336-20-0 DMF submitted to regulatory agencies in the US is known as a USDMF. 357336-20-0 USDMF includes data on 357336-20-0's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 357336-20-0 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of 357336-20-0 suppliers with USDMF on PharmaCompass.

    357336-20-0 KDMF

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

    Pharmaceutical companies submit a 357336-20-0 Drug Master File in Korea (357336-20-0 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 357336-20-0. The MFDS reviews the 357336-20-0 KDMF as part of the drug registration process and uses the information provided in the 357336-20-0 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a 357336-20-0 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 357336-20-0 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of 357336-20-0 suppliers with KDMF on PharmaCompass.

    357336-20-0 CEP

    A 357336-20-0 CEP of the European Pharmacopoeia monograph is often referred to as a 357336-20-0 Certificate of Suitability (COS). The purpose of a 357336-20-0 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 357336-20-0 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 357336-20-0 to their clients by showing that a 357336-20-0 CEP has been issued for it. The manufacturer submits a 357336-20-0 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 357336-20-0 CEP holder for the record. Additionally, the data presented in the 357336-20-0 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 357336-20-0 DMF.

    A 357336-20-0 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 357336-20-0 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 357336-20-0 suppliers with CEP (COS) on PharmaCompass.

    357336-20-0 WC

    A 357336-20-0 written confirmation (357336-20-0 WC) is an official document issued by a regulatory agency to a 357336-20-0 manufacturer, verifying that the manufacturing facility of a 357336-20-0 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 357336-20-0 APIs or 357336-20-0 finished pharmaceutical products to another nation, regulatory agencies frequently require a 357336-20-0 WC (written confirmation) as part of the regulatory process.

    click here to find a list of 357336-20-0 suppliers with Written Confirmation (WC) on PharmaCompass.

    357336-20-0 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 357336-20-0 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for 357336-20-0 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 357336-20-0 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 357336-20-0 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 357336-20-0 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of 357336-20-0 suppliers with NDC on PharmaCompass.

    357336-20-0 GMP

    357336-20-0 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 357336-20-0 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 357336-20-0 GMP manufacturer or 357336-20-0 GMP API supplier for your needs.

    357336-20-0 CoA

    A 357336-20-0 CoA (Certificate of Analysis) is a formal document that attests to 357336-20-0's compliance with 357336-20-0 specifications and serves as a tool for batch-level quality control.

    357336-20-0 CoA mostly includes findings from lab analyses of a specific batch. For each 357336-20-0 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.

    357336-20-0 may be tested according to a variety of international standards, such as European Pharmacopoeia (357336-20-0 EP), 357336-20-0 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (357336-20-0 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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