Lupin shares gain after Mandideep facility gets US FDA clean chit

The share touched a 52-week high of Rs 1,215.20 and a 52-week low of Rs 628.10 on 17 October, 2023 and 31 March, 2023, respectively.

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Shares of Lupin gained 0.6 percent to Rs 1,135.85 in the early trade on November 1 after the company received the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its Mandideep Unit-2 manufacturing facility.

The EIR was issued after the last inspection of the facility conducted during August 7 to 11 and closed with No Action Indicated (NAI) classification.

“We are pleased to receive the EIR with a satisfactory inspection status from the USFDA for the recent inspection of our Mandideep Unit-2 facility. This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally,” said Nilesh Gupta, managing director, Lupin.

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A meeting of the board of directors of the company will be held on November 8 to consider and take on record the unaudited financial results of the company for the quarter and half-year ended September 30, 2023.

Approvals in October

The company received approval from the US FDA for its abbreviated new drug application (ANDA) for Fluconazole tablets. This product is an equivalent of Diflucan tablets by Pfizer. This medication prevents and treats fungal or yeast infections.

The company also received the tentative approval from the US FDA for its ANDA for Apalutamide tablets, 60mg. This product is a generic equivalent of Erleada Tablets, 60mg of Janssen Biotech, Inc the product was available in the market from 2019.

The company received tentative approval from the US FDA for its ANDA for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg to market a generic equivalent of Jynarque tablets of Otsuka Pharmaceutical Co., Ltd.

The share touched a 52-week high of Rs 1,215.20 and a 52-week low of Rs 628.10 on October 17, 2023 and March 31, 2023. It was trading 6.53 percent below its 52-week high and 80.84 percent above its 52-week low.