Clonazepam

2024年7月30日，国家药品监督管理局官网显示，药友制药成员企业·湖南洞庭药业精神二类管制药品劳拉西泮片（1mg）通过仿制药质量和疗效一致性评价。 劳拉西泮片 1977年在美国获批上市，2003年进入国内，现已获批用于焦虑障碍的治疗或用于缓解焦虑症状以及与抑郁症状相关的焦虑的短期治疗。 劳拉西泮是一种苯二氮䓬类药物，通过与苯二氮䓬受体结合，增强GABA（γ-氨基丁酸）神经递质的作用，从而发挥镇静、抗焦虑、催眠和抗惊厥等效应。 指南推荐： 《广泛性焦虑障碍中西医结合诊疗指南（2023版）》推荐苯二氮䓬类药物如劳拉西泮、阿普唑仑等用于治疗广泛性焦虑障碍；  《中国成人失眠诊断与治疗指南（2023版）》推荐苯二氮䓬类药物如艾司唑仑、劳拉西泮等用于治疗失眠；  《新生儿惊厥临床管理专家共识（2022版）》推荐劳拉西泮为治疗新生儿惊厥的二线药物。 根据IQVIA CHPA数据，劳拉西泮市场规模3.01亿元，5年复合增长率14%，市场容量2.71亿片（以1mg计），多年连续保持快速增长。洞庭药业在该市场占比第一，稳居行业领先地位。 劳拉西泮片为国家医保甲类品种，国家基药，尚未纳入国家带量采购。截至发稿，已有4家企业通过一致性评价。该产品为洞庭药业首个过评的管制类品种，亦为原料制剂一体化，市场竞争力显著，可充分保障市场供应与患者使用。 已通过一致性评价企业 CNS领域是药友核心领域之一。截至目前，CNS领域共17个品种29个品规通过/视同通过一致性评价，多个品种为首家/独家。 相关链接 药友制药成员企业 • 湖南洞庭药业 洞庭药业是药友制药旗下成员企业，创建于1958年，位于湖南常德，是国内精神科药物和化学止血药领域的领先企业。 经过多年的技术革新和市场竞争，止血药和精神科药成为洞庭药业的主导产品。止血药氨甲环酸、氨甲苯酸形成了产销规模大、质量好的超前优势；精神科药走上了品种、规格、剂型齐步发展的快车道，主要类别有抗精神分裂症药、抗抑郁药、抗癜痫药、镇静催眠药。 洞庭药业厂区图 洞庭药业是湖南省级企业技术中心，省精神药物工程技术研究中心、拥有省著名商标、省国际知名品牌等荣誉称号以及“止血环酸的生产方法” “制备药物纯富马酸喹硫平的生产方法” “富马酸喹硫平缓控释制剂组合物及其应用”等多项国家发明专利和外观专利。 洞庭药业建立了可靠的产品质量保障体系，全部产品取得了国家GMP认证证书。氨甲环酸质量符合美国药典、英国药典、日本药局方和欧洲药典标准，并通过了美国FDA、英国MHRA、欧盟COS、日本PMDA认证，出口到30多个国家和地区，拥有劳拉西泮片、阿普唑仑片、氯硝西泮片等精神二类管制药品生产资质。

This significant milestone, achieved following a comprehensive five-day on-site inspection from April 29 to May 3, 2024, marks a critical step in Rusan Pharma’s expansion into the US API market. Dr Kunal Saxena, managing director of Rusan Pharma, said: “This GMP approval by the US Food and Drug Administration underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards.” The Ankleshwar facility’s GMP approval allows Rusan Pharma to significantly enhance its presence in the US market, particularly with its active US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride. Expansion into the US API market The company plans to expand its API portfolio to include Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam. Rusan Pharma's strategic focus includes supplying APIs to US-based companies involved in orphan drugs, addiction treatment, and obesity medications. The US FDA approval will bolster Rusan's capabilities, allowing it to broaden its API product portfolio and increase its footprint in the US pharmaceutical sector. The Ankleshwar facility is also GMP approved by other stringent international agencies, including Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan Pharma has implemented 21-CFR-compliant software solutions such as SAP, Laboratory Information Management System (LIMS), document and quality management systems (DMS & QMS), and electronic logbooks to ensure paperless manufacturing. The company faced and overcame significant challenges in transitioning to these systems, including comprehensive staff training and monitoring. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Strategic international certifications Prior to this approval, Rusan Pharma had established a robust presence in key markets such as Australia, Brazil, Canada, the EU, Mexico, New Zealand, and the United Kingdom. The US FDA's endorsement now enables Rusan to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further strengthens global trust and confidence in Rusan’s products and processes. “Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management,” added Dr. Saxena. “Integration with API enables us to remain competitive while promoting our finished formulations in the global market. It also enables us to be independent from other companies for the supply of critical APIs for manufacturing various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business, and a robust supply of API enables us to achieve a rapid time to market with critical products.” New API manufacturing facility in Pithampur The Ankleshwar manufacturing unit plays a strategic role in Rusan’s manufacturing and distribution network, particularly for critical APIs like fentanyl and buprenorphine. The company’s vision is to ensure the competitive and timely delivery of quality medicines in addiction treatment and pain management sectors. In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ, Madhya Pradesh, with an annual production capacity of up to 400 metric tons, significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection for this new facility by the US FDA and other international inspecting agencies, aiming to further boost its manufacturing capabilities. Rusan Pharma’s continued expansion and adherence to stringent quality standards underscore its commitment to excellence and its strategic vision of becoming a leading global player in the pharmaceutical industry.