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About Pregabalin API

Product
  • Therapeutic Category中枢神经系统 (CNS)

  • API Technology

    Synthetic

  • Dose Form

    Capsule/ Tablet

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

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

作用机制

"LYRICA (pregabalin) binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium-dependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha2-delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gammaaminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake."

适应症

LYRICA is indicated for:

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) • Postherpetic neuralgia (PHN)
  • Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older
  • Fibromyalgia
  • Neuropathic pain associated with spinal cord injury

Dr. Reddy's的专长

Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 普瑞巴林 API是研发,知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。

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Related Resources

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FAQs

What is Pregabalin API used for?
  • Treats neuropathic pain, fibromyalgia, and partial-onset seizures

What is the dosage form and strength currently available for Pregabalin?
  • Available as oral capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg

How do you store Pregabalin API?
  • Store at 20°C to 25°C (68°F to 77°F), in a tightly closed container, protect from moisture

免责声明

本網站上的任何信息,包括對任何產品或服務的任何提及,均不構成銷售要約或被解釋為代表銷售要約。受有效專利保護的產品不得提供或供應用於商業用途。但是,在某些情況下,雷迪博士可自行決定並根據當地法律要求,在存在此類監管豁免的任何地方,提供此類產品的研究數量,以根據《印度專利法》第 107A 條(Bolar 豁免)進行監管提交。購買者應對其各自市場的產品或服務(包括專利情況)進行獨立評估,並對所有與專利相關的責任負責。 Dr. Reddy's 不承擔任何明示或暗示的保證,包括但不限於適銷性、適用於特定用途和非侵權的保證。

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.