Brivaracetam API Manufacturers and Suppliers in India

Brivaracetam API

Brivaracetam API (CAS 357336-20-0) is an antiepileptic active ingredient of the racetam class, supplied as a white to off-white powder for oral tablets, oral solution and injection used for partial-onset seizures. We manufacture Brivaracetam at our Balanagar, Hyderabad site and release every batch with a Certificate of Analysis.

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Product Description

Product Description

Product name: Brivaracetam API

Chemical name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide

CAS number: 357336-20-0

Molecular formula: C11H20N2O2

Molecular weight: 212.29 g/mol

Category: Anticonvulsant / antiepileptic (SV2A ligand)

Therapeutic use: Partial-onset seizures in epilepsy

Physical form: Powder, white to off-white

Solubility: Highly soluble in water, ethanol, methanol and glacial acetic acid; freely soluble in acetonitrile and acetone; soluble in toluene

Packing: As per customer requirement

Synonyms: (alphaS,4R)-alpha-Ethyl-2-oxo-4-propyl-1-pyrrolidineacetamide

A point to check when comparing quotes: Brivaracetam has two stereocentres and is supplied as the single (2S,4R) isomer. A quote that is silent on the diastereomer and enantiomer limits is not comparable with one that states them, because chiral purity is the specification item that separates a pharmaceutical grade from a technical one. Note also that the molecular weight is 212.29 g/mol, the average mass; 212.15 is the monoisotopic mass and should not appear on a CoA.

Brivaracetam API Specification

Each batch is released with a Certificate of Analysis. For a single-isomer API of this kind the CoA typically covers appearance, solubility, identification by IR, water content, assay, related substances, chiral purity (the (2S,4S) diastereomer and the (2R,4S) enantiomer) and residual solvents.

The limits we publish today:

Test

Limit

Assay by HPLC

Not less than 98.0% 

Any unspecified impurity

Not more than 0.5%

Total impurities

Not more than 2.0%

Water content by KF

Not more than 0.5% w/w

Solubility

Soluble in methanol

Brivaracetam is highly water-soluble, so dissolution is rarely the formulation problem. The API parameters that matter to a tablet or oral solution developer are chiral purity, water content and the residual solvent profile, because the crystallisation and drying steps set all three. ICH Q1A is the framework a reviewer will expect the retest period to have been set under.

Brivaracetam API Manufacturers in India

We are Biochemical and Synthetic Products Private Limited, and we have made APIs and intermediates in Hyderabad since 1943. The plant is at Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, and operates under Telangana manufacturing licence 118/HD/AP/96/B/R. The company background is on the our story page.

Brivaracetam is a stereochemistry problem before it is anything else. The published routes build the 4-propyl-pyrrolidinone ring, then attach the (S)-2-aminobutanamide side chain, and either resolve the diastereomers by chromatography or crystallisation or start from a chirally pure lactone. Every route produces the (2S,4S) diastereomer as the main impurity, and the step where it is removed decides the yield and the final chiral purity. When the API manufacturer runs that purification itself, the diastereomer level on the CoA reflects its own process control rather than a purchased intermediate’s.

The reaction types available at the site, including the chiral and amide chemistry this molecule needs, are listed on the reaction capabilities page. ICH Q7 requires that process changes go through formal change control and that customers be notified of any change that could affect the quality of material they have filed in a dossier.

A more comprehensive discussion of the impurities and their origin is in our Brivaracetam API impurity profile and stability studies guide.

Brivaracetam API Suppliers in India

Brivaracetam is a low-dose, high-value API, so order sizes are small compared with high-dose molecules and packing is sized to match. Each pack is labelled with the product name, batch number, manufacturing and retest dates and the storage condition, matching the CoA sent with the consignment.

The document set for a first order is the batch CoA, the Safety Data Sheet and the specification sheet, with a method of analysis, a stability summary and an impurity profile available on request.

A first order runs as follows: enquiry with quantity and target specification, specification sheet and sample, sample testing at the buyer’s site, commercial terms, then the batch.

Brivaracetam API Price in India

We quote Brivaracetam API per order. The price is driven by the chiral purity specification required, the order quantity, packing, and lead time. A tighter diastereomer limit costs more because it means more material lost at the purification step; that is a chemistry fact, not a negotiating position. Larger quantities on a planned schedule are quoted lower per kilogram than small urgent lots.

Public marketplace listings for Brivaracetam in India show a wide spread depending on grade, quantity and whether the seller is a manufacturer or a trader. Those third-party figures are not our price. Send the quantity and specification through the enquiry form and a written quotation follows.

Quality and Compliance

Our quality management system is certified to ISO 9001:2015 by DNV Business Assurance UK Limited under UKAS accreditation, certificate 156792-2014-AQ-IND-UKAS, first certified on 20 August 2002. The certified scope reads: “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable.”

The Balanagar site holds a WHO-GMP certificate from the Drugs Control Administration, Government of Telangana (L.Dis.No. 150458/TS/2024, dated 6 June 2024, valid to 5 June 2027).

Brivaracetam is manufactured in line with ICH Q7 principles, as set out in our own GMP declaration. ICH Q7 requires a quality unit independent of production, validated cleaning between campaigns, and traceability from starting material to release. ICH Q3A and Q3C are the frameworks a reviewer reads the related-substances and residual-solvent limits on our CoA against. We hold no USFDA, EU GMP, CEP or DMF status for Brivaracetam, and this page does not claim one. The site’s systems are described on the pharmaceutical quality assurance page.

How Brivaracetam Works and Where It Is Used

Brivaracetam binds selectively to synaptic vesicle protein 2A (SV2A) in the brain, the same target as levetiracetam, but with roughly twenty-fold higher affinity and faster brain penetration. Binding SV2A modulates neurotransmitter release and reduces the abnormal synchronous firing that produces a seizure. It also shows some inhibition of voltage-gated sodium channels.

It is approved for partial-onset seizures in adults and children, as add-on therapy and, in markets whose label allows it, as monotherapy. Finished dosage forms are film-coated tablets from 10 mg to 100 mg, an oral solution and an injection. How the two SV2A ligands compare in practice, and what that means for demand, is covered in our Brivaracetam vs Levetiracetam API comparison.

Brivaracetam API FAQs

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    Brivaracetam is an antiepileptic drug of the racetam class. It works as a selective ligand of synaptic vesicle protein 2A (SV2A) and is used for partial-onset seizures.

    We manufacture Brivaracetam API at our Balanagar, Hyderabad site under the name Biochemical and Synthetic Products Private Limited. Several other Indian companies also produce it; compare the chiral purity specification and the documentation offered, rather than price alone.

    The CAS number is 357336-20-0. The molecular formula is C11H20N2O2 and the molecular weight is 212.29 g/mol.

    Both bind SV2A. Brivaracetam is the 4-propyl analogue of levetiracetam, binds SV2A with much higher affinity, and is dosed at 50 mg to 200 mg per day against 1,000 mg to 3,000 mg for levetiracetam. As an API it is a higher-value, lower-volume material with a harder chiral purity specification.

    Our site is ISO 9001:2015 certified and we manufacture Brivaracetam in line with ICH Q7 principles. The site also has a WHO-GMP certificate for select products.

    Ask for one. Send the target specification and intended use through the enquiry form and our sales team will confirm sample availability, quantity and charge.

    Price is quoted per order and depends on the chiral purity specification, quantity, packing and lead time. We do not publish a list price.

    Request a Quotation

    Send the quantity, the target specification (including the chiral purity limits you need), the destination country and the dosage form you are developing. A specification sheet, a sample CoA and a written quotation come back from our sales team. Use the contact page to reach them.

    Brivaracetam sits in the CNS group of our range. The full list of APIs we manufacture is in our API portfolio.