Lupin Receives Tentative USFDA Approval for Tolvaptan Tablets; Shares Gain

Lupin Receives Tentative USFDA Approval for Tolvaptan Tablets; Shares Gain
Lupin Receives Tentative USFDA Approval for Tolvaptan Tablets; Shares Gain

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

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The drug company has received interim approval from the USFDA for tolvaptan 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets. This drug is a generic drug of Otsuka Pharmaceutical Co., Ltd.’s Zinark tablet. 

 

The tablets in question are manufactured at Lupin’s Nagpur factory in India. On October 3, the company announced the launch of a patient support program called ‘Humrahi’ that guides patients into a new era of diabetes management through adherence, action and transformation.

 

 In September, the company received an EIR (Equipment Inspection Report) from US regulators for its Nagpur Unit 1 manufacturing plant, which manufactures oral solid dosage forms.

 

 The EIR was issued after the USFDA conducted an inspection of the production unit in July 2023 and determined the facility’s inspection classification to be a VAI (Voluntary Action Instruction). 

 

As of 12:05 pm, Lupine shares were trading at Rs 1,155 on the NSE, 0.50 per cent higher than the previous closing price.

 

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