Levetiracetam API
CAS Number: 102767-28-2
About Levetiracetam API
Therapeutic Category
Central Nervous System (CNS)
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
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.
Related Resources
Enhancing Supply Chain Security for Levetiracetam API
December, 2019
In this article we look at the factors, which can make an impact to ensure a reliable supply chain. Levetiracetam, one of the key APIs in our portfolios, is a model API, which shows how a diligent backward integration together with flexible capacities can enhance the security of the supply chain.
A brief background: Since 2017, the Chinese Government enforced environmental laws and regulations1) across the country to clean up air, water and upgrade its production efficiency. These regulations impacted numerous Key Starting Material suppliers resulting best case in a multifold price increase and worst case in a supply shortage. Our team at Dr Reddy’s implemented a diligent concept to tackle this situation in record time. The following 3 factors showed:
- Localization of KSM – Dr. Reddy’s entered into a strategic tie-up with China vendors and Indian business partners to transfer the technology/Know-how of KSM to India. Additionally, Dr Reddy’s further improved the technology in order to make it more sustainable by minimising the waste generation and re-using the solvents/reagents. Instead of shipping the KSM all the way from China, a local supplier can deliver faster and more flexible.
- Backed up by an alternative source – to further strengthen the supply chain, Dr. Reddy’s established another source for KSM in India. Following the same optimization principals as, mentioned above supplier has been qualified with approvals from global regulatory authorities including the USFDA and EDQM- in a record four months’ time.
- Scaling manufacturing capacities – To meet the increasing demand and to address the shortage, Dr. Reddy’s expanded the manufacturing capacity for Levetiracetam. The higher capacity ensures fastest turnaround times. Our process engineering team have developed crystallization processes and size reduction operations to meet customized physico-chemical properties such as, but not limited to, particle size, bulk density (tapped /untapped) .
Within three to four months our OTIF (on time and in full) performance increased to 100 % and so did customer satisfaction. Today, Dr Reddy’s has achieved a competitive position in supporting the global Levetiracetam API demands.
Explore our Levetiracetam offering by clicking on the link below:
https://api.drreddys.com/product/levetiracetam
Reference
1) http://www.gov.cn/zhengce/content/2016-11/21/content_5135510.htm
Disclaimer:
The scientific content of this article has been developed by Dr.Reddy’s Laboratories Limited (“DRL”) for educational and awareness purpose only. Although greatest possible care has been taken in compiling, checking and developing the content to ensure that it is accurate and complete, the authors, DRL, are not responsible or in any way liable for any injury or damage to any persons in view of any reliance placed on or action taken basis of the information in this article or any errors, omissions or inaccuracies and/or incompleteness of the information in this article, whether arising from negligence or otherwise. No part of the article including graphics available in this presentation may be copied or reproduced, in whole or in part, without the consent of DRL, other than for purposes permitted under fair use by copyright law.
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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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