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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.


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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740940200,"product":"BRIVARACETAM","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"RIYADH","customer":"JPI - CENTRAL WAREHOUSE","customerCountry":"SAUDI ARABIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"2350","totalValueFC":"27249","currency":"USD","unitRateINR":196686.83333333334,"date":"03-Mar-2025","totalValueINR":"2360242","totalValueInUsd":"27249","indian_port":"Vizag-HIPL SEZ","hs_no":"29242990","bill_no":"8676132","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741804200,"product":"BRIVARACETAM (INJECTABLE GRADE)","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"APEX PHARMACEUTICALS, INC.","customerCountry":"EGYPT","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"850","totalValueFC":"25252.4","currency":"USD","unitRateINR":72910.066666666666,"date":"13-Mar-2025","totalValueINR":"2187302","totalValueInUsd":"25252.4","indian_port":"Hyderabad Air","hs_no":"29331920","bill_no":"8989744","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Sterile","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"BRIVARACETAM","year":"2021","qtr":"Q1","strtotime":1615141800,"product":"(R)-4-PROPYLDIHYDROFURAN-2 (3H)-ONE (USE AS AN INTERMEDIATEFOR MFR.OF BRIVARACETAM)","address":"1060,INDL. AREA,PHASE-II","city":"CHD.","supplier":"ZHEJIANG SHINDAI CHEMICALS ","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CADCHEM LABORATORIES","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1000","totalValueFC":"5075.5","currency":"USD","unitRateINR":"73900","date":"08-Mar-2021","totalValueINR":"369500","totalValueInUsd":"5075.5","indian_port":"DELHI AIR","hs_no":"29335990","bill_no":"3050491","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"1060,INDL. AREA,PHASE-II"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1634668200,"product":"(S)-2-(R)-2-OXO-4-PROPYLPYRROLIDIN-1-YL) BUTANAMIDE, BRIVARACETAM","address":"1ST FLOOR ,PLOT NO 4, K K CHAMBERS PURUSHOTTAMDAS THAKURDAS ROAD FORT","city":"MUMBAI","supplier":"PHAROS LTD","supplierCountry":"MALTA","foreign_port":"NA","customer":"ZENVISION PHARMA","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"16000","totalValueFC":"9475.1","currency":"EUR","unitRateINR":"1419600","date":"20-Oct-2021","totalValueINR":"709800","totalValueInUsd":"9475.1","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"5922461","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1ST FLOOR ,PLOT NO 4, K K CHAMBERS PURUSHOTTAMDAS THAKURDAS ROAD FORT"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656441000,"product":"(REJECTED AND RETURNED)312467 BRIVARACETAM BRIVARACETAM GENBATCH N BIV7O21013 PO217028710","address":"NO 31, RACE COURSE ROAD BANGALORE Contact No: 919945641620","city":"BENGALURU","supplier":"KRAEMER & MARTIN PHARMA HANDELS GMBH DE 47804 KREFELD","supplierCountry":"INDIA","foreign_port":"NA","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"10.57","actualQuantity":"10.57","unit":"KGS","unitRateFc":"6300","totalValueFC":"68279.6","currency":"USD","unitRateINR":"503959.6","date":"29-Jun-2022","totalValueINR":"5326852.92","totalValueInUsd":"68279.6","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"9336787","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 31, RACE COURSE ROAD BANGALORE Contact No: 919945641620"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677781800,"product":"(FOC) COMMON BLEND OF BRIVARACETAM TABLETS 10MG, 25MG, 50,G75MG & 100MG","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"MALTA","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.27","actualQuantity":"270","unit":"GMS","unitRateFc":"0.6","totalValueFC":"196.7","currency":"EUR","unitRateINR":"59.9","date":"03-Mar-2023","totalValueINR":"16176.8","totalValueInUsd":"196.7","indian_port":"BOMBAY AIR","hs_no":"29337990","bill_no":"4891309","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"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. Contac","city":"NAVI MUMBAI","supplier":"PHARMAPATH","supplierCountry":"INDIA","foreign_port":"NA","customer":"SOLARA ACTIVE PHARMA SCIENCES","customerCountry":"INDIA","quantity":"2.25","actualQuantity":"2.25","unit":"KGS","unitRateFc":"2500","totalValueFC":"6024.5","currency":"USD","unitRateINR":"220231.1","date":"26-Mar-2023","totalValueINR":"495519.86","totalValueInUsd":"6024.5","indian_port":"MADRAS AIR","hs_no":"29420090","bill_no":"5232956","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717957800,"product":"BRIVARACETAM (NON STERILE BULK)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"AURISCO PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"2900","totalValueFC":"87855.2","currency":"USD","unitRateINR":"244470","date":"10-Jun-2024","totalValueINR":"7334100","totalValueInUsd":"87855.2","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337990","bill_no":"1000830","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI","supplierAddress":"NO.28, JIAN'AN ROAD, HIG-TECH INDUSTRIAL DEVELOPMENT ZONE,YANGZHOU CITY, JIANGSU PROVINCE 225100,P.R. CHI China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"BRIVARACETAM (NON STERILE -BULK)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"YANGZHOU AURISCO PHARMACEUTICAL CO L;TD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PU DONG APT","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"78.00","actualQuantity":"78","unit":"KGS","unitRateFc":"2450","totalValueFC":"193605.6","currency":"USD","unitRateINR":"208005","date":"09-Sep-2024","totalValueINR":"16224390","totalValueInUsd":"193605.6","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337990","bill_no":"5499507","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI PU DONG APT","supplierAddress":"NO 28 JIAN AN ROAD HIGH-TECH INDUST ZONE YANGZHOU CITY JIANGSU PROVINCE SDNF China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"BRIVARACETAM (NON STERILE -BULK)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"YANGZHOU AURISCO PHARMACEUTICAL CO L;TD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PU DONG APT","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"82.00","actualQuantity":"82","unit":"KGS","unitRateFc":"2450","totalValueFC":"202868.8","currency":"USD","unitRateINR":"207882.5","date":"17-Oct-2024","totalValueINR":"17046365","totalValueInUsd":"202868.8","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337990","bill_no":"6172711","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI PU DONG APT","supplierAddress":"NO 28 JIAN AN ROAD HIGH-TECH INDUSTRIAL ZONE YANGZHOU CITY SDNF 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-4000438 DT:30.05.2024, RID NO-252402166866)","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"RIHU HEALTHCARE","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"INCHEON","customer":"HONOUR LAB LTD","customerCountry":"INDIA","quantity":"102.00","actualQuantity":"102","unit":"KGS","unitRateFc":"1804.9","totalValueFC":"185961.4","currency":"USD","unitRateINR":"157208.8","date":"27-Jan-2025","totalValueINR":"16035300","totalValueInUsd":"185961.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29242990","bill_no":"1000047","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,"}]
06-Jan-2021
13-Mar-2025
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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.

Brivaracetam Manufacturers

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

Brivaracetam Suppliers

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

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

Brivaracetam USDMF

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

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

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

Brivaracetam KDMF

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

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

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

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

Brivaracetam CEP

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

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

Brivaracetam WC

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

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

Brivaracetam 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 Brivaracetam as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Brivaracetam GMP

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

Brivaracetam CoA

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

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

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