Lupin Receives US FDA's Favorable Report for Mandideep Unit-2 Facility

1 Nov 2023 , 02:01 PM

Lupin’s shares saw a 0.6 % gain, reaching Rs 1,135.85 in early trade on November 1, following the receipt of the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its Mandideep Unit-2 manufacturing facility.

The EIR was granted after the facility underwent its most recent inspection from August 7 to 11, concluding with a No Action Indicated (NAI) classification.

Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the receipt of the EIR, emphasizing the company’s commitment to maintaining high-quality standards and compliance. This achievement allows Lupin to continue providing quality and affordable healthcare solutions globally.

A board of directors meeting will be held on November 8 to review and acknowledge the company’s unaudited financial results for the quarter and half-year ending on September 30, 2023.

Lupin also obtained approval from the US FDA for its abbreviated new drug application (ANDA) related to Fluconazole tablets, which are an equivalent of Pfizer’s Diflucan tablets and are used to prevent and treat fungal or yeast infections.

Additionally, the company received tentative approval from the US FDA for its ANDA for Apalutamide tablets, 60mg, a generic equivalent of Janssen Biotech, Inc’s Erleada Tablets, 60mg, which have been available in the market since 2019.

Lupin received tentative approval from the US FDA for its ANDA for Tolvaptan Tablets in various strengths (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg), enabling the marketing of a generic equivalent to Otsuka Pharmaceutical Co., Ltd.’s Jynarque tablets.

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