Zydus Lifesciences于周六表示，美国食品药品监督管理局（USFDA）对其位于新泽西州的药理监测和上市后监管系统的检查结果为无问题。
Zydus Lifesciences on Saturday said a US Food and Drug Administration inspection of its pharmacovigilance and post-marketing surveillance system at its New Jersey, US office concluded with nil observations.
该公司在一份文件中称，此次检查于2026年9月22日至25日进行。
The inspection was conducted from September 22 to September 25, 2026, the company said in an exchange filing.
检查涵盖了其药理监测和上市后监管系统，并在其美国办公室现场进行。
Zydus said the inspection covered its pharmacovigilance and post-marketing surveillance system and was conducted onsite at its US office.
Zydus根据2015年SEBI法规第30条披露了这一进展。
The company disclosed the development under Regulation 30 of the SEBI Regulations, 2015.
Zydus Lifesciences的股票在印度证券交易所（BSE）和国家证券交易所上市。
Zydus Lifesciences shares are listed on the BSE and National Stock Exchange of India.
早在8月份，Zydus Lifesciences就获得了其阿斯corbic Acid Injection（抗坏血酸注射液）仿制药的最终FDA批准，该产品在美国的年销售额约为1160万美元。
Earlier in August, Zydus Lifesciences had received final USFDA approval for its generic version of Ascorbic Acid Injection, a product with annual US sales of around $11.6 million.
此次批准涵盖了两种剂量的阿斯corbic Acid Injection USP——25,000毫克/50毫升和5,000毫克/10毫升，浓度均为500毫克/毫升。
The approval covered Ascorbic Acid Injection USP in two strengths — 25,000 mg/50 mL and 5,000 mg/10 mL — both at a concentration of 500 mg/mL.
根据公司介绍，美国监管机构将Zydus的该产品的新药申请归类为竞争性仿制药，使其有资格获得180天的独家销售期。
The US regulator had designated Zydus' abbreviated new drug application for the product as a Competitive Generic Therapy , making it eligible for potential 180-day exclusivity, according to the company.
该注射液用于成人和5个月及以上儿童在无法口服、口服不足或禁忌情况下的短期治疗坏血病。
The injection is used for the short-term treatment of scurvy in adults and children aged five months and older when oral administration is not possible, insufficient or contraindicated.
Zydus表示，该产品将在其位于古吉拉特邦Vadodara附近的Jarod的FDA批准注射生产设施中生产，并通过Zydus Pharmaceuticals Inc.在美国销售。该公司称，其产品是参考药品Ascor的仿制药。
Zydus said the product would be manufactured at its USFDA-approved injectable facility in Jarod, near Vadodara, Gujarat, and marketed in the US through Zydus Pharmaceuticals Inc.The company said its product is the generic equivalent of Ascor, the reference listed drug.
180天独家销售期的资格由FDA决定，如适用，该期限从产品上市第一天开始计算。
Eligibility for the 180-day exclusivity is determined by the USFDA and, where applicable, the period begins on the first day of commercial marketing.