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Levetiracetam

Levetiracetam-API

CAS Number: 102767-28-2

Therapeutic Category
Central Nervous System (CNS)
API Technology
Synthetic
Dose Form
Oral Solids
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
CEP Granted
Brazil DMF
Canada DMF
Japan DMF
Korea DMF
Innovator Brand (USA)
SPRITAM

Mechanism of Action

The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain.

Indication

SPRITAM is indicated for adjunctive therapy in the treatment of: 

  • Partial onset seizures in patients with epilepsy 4 years of age and older weighing more than 20 kg 
  • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy 
  • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Levetiracetam API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Levetiracetam API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

FAQs

A novel antiepileptic drug used in the treatment of partial seizures, myoclonic seizures, and tonic-clonic seizures.

1000 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.

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