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Lupin Receives Tentative USFDA Approval for Tolvaptan Tablets; Shares Gain

The company are exclusive first-to-file for this product and are eligible for 180-day exclusivity.

Lupin shares opened 1% above on 6 October after the company announced receiving tentative approval from USFDA ( the United States Food and Drug Administration).

The pharmaceutical company has received tentative approval from the USFDA for its Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.

The drug is a generic equivalent of Jynarque tablets of Otsuka Pharmaceutical Co., Ltd.

The said tablets will be manufactured at Lupin’s Nagpur facility in India.

On 3 October, the company announced the launch of a patient support program, Humrahi, guiding patients in a new era of diabetes management through adherence, behaviour and transformation.

In September, the company received an EIR (Establishment Inspection Report) from the US regulator for its Nagpur Unit-1 manufacturing facility that manufactures oral solid dosage forms.

The EIR was issued after the USFDA conducted an inspection of the manufacturing unit in July 2023 and determined that the inspection classification of the facility is VAI (Voluntary Action Indicated).

At 12:05 pm, the shares of Lupin were trading at Rs 1,155 or 0.50% above its previous close on NSE.

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