MUMBAI, India and WARREN, N.J., May 22, 2024 /PRNewswire/ -- Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as 'Cipla') and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as 'Cipla'), today announced that it has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United States Food and Drug Administration (USFDA)..

印度孟买和新泽西州沃伦，2024年5月22日/PRNewswire/--Cipla Limited（BSE:500087；NSE:Cipla EQ；以下简称“Cipla”）及其全资子公司Cipla USA Inc.（以下简称“Cipla”）今天宣布，其兰瑞肽注射液120 mg/0.5 mL，90 mg/0.3 mL，60 mg/0.2 mL的缩写新药申请（ANDA）已获得美国食品和药物管理局（USFDA）的最终批准。。

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline® Depot (Lanreotide) Injection. Lanreotide Injection is supplied as 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL single-dose, pre-filled, ready-to-inject syringe. Cipla's Lanreotide injection is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)..

Cipla的兰瑞肽注射液是Somatuline®Depot（兰瑞肽）注射液的等效治疗通用版本。Lanreotide注射液以120 mg/0.5 mL、90 mg/0.3 mL、60 mg/0.2 mL单剂量、预填充、准备注射注射器的形式提供。Cipla的兰瑞肽注射液适用于治疗肢端肥大症和胃肠胰神经内分泌肿瘤（GEP-NETs）患者。。

According to IQVIA (IMS Health), Somatuline® Depot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.

据IQVIA（IMS Health）称，截至2024年3月的12个月期间，Somatuline®Depot（Lanreotide）在美国的销售额约为8.98亿美元。

About Cipla:

关于Cipla：

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments are well-known.

Cipla成立于1935年，是一家全球性制药公司，专注于在印度、南非、北美等国内市场以及主要受监管和新兴市场的敏捷和可持续增长、复杂仿制药和深化投资组合。我们在呼吸、抗逆转录病毒、泌尿科、心脏病学、抗感染和中枢神经系统领域的优势是众所周知的。

Our 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Feb'24), 1st in the pharma prescription market in South Africa (IQVIA MAT Feb'24), and 4th largest by prescription in the US Gx inhalation products (IQVIA MAT Feb'23).

我们在世界各地的47个生产基地使用尖端技术平台生产50多种剂型和1500多种产品，以满足我们80多种市场的需求。Cipla在印度制药行业排名第三（IQVIA MAT 2月24日），在南非制药处方市场排名第一（IQVIA MAT 2月24日），在美国Gx吸入产品（IQVIA MAT 2月23日）处方排名第四。

For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility, and affordability to the centre of the HIV movement.

80多年来，对患者产生影响激发了Cipla工作的方方面面。2001年，我们在非洲以每天不到一美元的价格提供了针对艾滋病毒/艾滋病的三重抗逆转录病毒疗法，这一改变范式的提议被广泛认为有助于为艾滋病毒运动的中心带来包容性、可及性和可负担性。

A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers, and all stakeholders..

作为一名负责任的企业公民，Cipla的人道主义医疗保健方法追求“关爱生命”的宗旨，以及在任何地方都有根深蒂固的社区联系，使其成为全球卫生机构、同行和所有利益相关者的首选合作伙伴。。

For more, please visit https://www.cipla.com, or click on Twitter, Facebook, LinkedIn.

欲了解更多信息，请访问https://www.cipla.com，或者单击Twitter、Facebook、LinkedIn。

SOURCE Cipla

来源Cipla