After receiving a clean sheet from the US FDA, Lupin shares rise

 After receiving a clean sheet from the US FDA, Lupin shares rise

The share had a 52-week high of Rs 1,215.20 on October 17, 2023, as well as a 52-week low of Rs 628.10 on March 31, 2023.

Following receipt of the establishment inspection report (EIR) for business Mandideep Unit-2 manufacturing facility with the US Food and Drug Administration (US FDA), Lupin's shares increased by 0.6 percent to Rs 1,135.85 in early trading on November 1.

Following the facility's most recent inspection, which took place from August 7 to August 11, an EIR was published with a No Action Indicated (NAI) designation.

"We are happy to have received the EIR for our Mandideep Unit-2 facility's recent inspection from the USFDA with an acceptable inspection status. This achievement allows us to keep providing high-quality, reasonably priced healthcare products throughout the world and is consistent with our ongoing emphasis and dedication to become best-in-class in quality and compliance, according to Nilesh Gupta, managing director of Lupin.

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The company's unaudited financial statements for the quarter and half-year through September 30, 2023, will be discussed and recorded at a meeting of the board of directors on November 8.

Acceptances in October

The US FDA approved the company's abbreviated new drug application (ANDA) for capsules of fluconazole. This product is a substitute for Pfizer's Diflucan pills. This drug both prevents and cures yeast or fungal infections.

Additionally, the US FDA tentatively approved the company's ANDA for 60mg of Apalutamide tablets. This product is a generic version of Janssen Biotech, Inc.'s Erleada Tablets, 60mg. It was introduced to the market in 2019.

The US FDA granted the business provisional clearance for its ANDA for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, which aims to sell a generic version of Otsuka Pharmaceutical Co., Ltd.'s Jynarque tablets.

On October 17, 2023, and March 31, 2023, the share saw a 52-week high of Rs 1,215.20 and a 52-week low of Rs 628.10. At that moment, it was trading 80.84 percent above its 52-week low and 6.53 percent below its 52-week high.