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About Levetiracetam API

Product
  • Therapeutic Category中枢神経系 (CNS)

  • CAS Number

    102767-28-2

  • API Technology

    Synthetic

  • Dose Form

    Hard Gelatin Capsule/Tablet for Suspension

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, China DMF

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の専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

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Related Resources

Enhancing Supply Chain Security for Levetiracetam API

Enhancing Supply Chain Security for Levetiracetam API

Authors: AVT Reddy, Head - API Supply Chain; B Shivakumar, Product Manager - 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:

  1. 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.
  2. 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.
  3. 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

FAQs

What is main purpose of using the levetiracetam API ?
  • A novel antiepileptic drug used in the treatment of partial seizures, myoclonic seizures, and tonic-clonic seizures.

What is the safety guide for levetiracetam API ?
  • 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.

What is the process available for ordering levetiracetam API ?

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