Aurobindo Pharma Ltd on Wednesday said a new injectable facility of Eugia Steriles Private Limited which was inspected by the US Food and Drug Administration (FDA) received its first product approval. Eugia Steriles Private Limited is a 100 per cent subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of Aurobindo Pharma.

Aurobindo Pharma Ltd周三表示，经美国食品和药物管理局（FDA）检查的Eugia Steriles Private Limited的一家新注射设施获得了首次产品批准。Eugia Steriles Private Limited是Eugia Pharma Specialities Limited的全资子公司，也是Aurobindo Pharma的下属子公司。

A press release from the drugmaker said the plant located in Andhra Pradesh was inspected by the US regulator from March 28 to April 5, this year. The FDA approved Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL). The SANDA (supplemental Abbreviated New Drug Application) for the product was submitted as 'Prior Approval Supplement' for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

该制药商发布的新闻稿称，位于安得拉邦的工厂于今年3月28日至4月5日接受了美国监管机构的检查。FDA批准的盐酸利多卡因注射液，USP，1%（10 mg/mL）和2%（20 mg/mL）。该产品的SANDA（补充缩写新药申请）作为“事先批准补充”提交，以添加替代药品制造，标签，包装和测试设施。（您现在可以订阅我们的经济时报WhatsApp频道）（您现在可以订阅我们的经济时报WhatsApp频道）。