USFDA gives approval to Lupin Pregabalin capsules

The product will be manufactured at Lupin’s facility in Aurangabad, India.

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USFDA Approval
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Lupin, an innovation-led transnational pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), pregabalin capsules.

Pregabalin capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg to market a generic equivalent of Lyrica capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of Upjohn US 2 LLC.

The product will be manufactured at Lupin’s facility in Aurangabad, India.

Pregabalin capsules (Lyrica) had estimated annual sales of USD 263 million in the US (IQVIA MAT March 2022).

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