1. Generics Bulletin

Lupin Delivers On US Generic Spiriva Approval

Indian Firm Celebrates Long-Awaited FDA Nod For Tiotropium Dry Powder Inhaler

 
• By Dave Wallace

Lupin has gained a long-awaited FDA approval for its US generic version of Spiriva. The product is seen as a major element of Lupin’s respiratory franchise and a key contributor to the Indian firm’s fortunes this year.

Clouds in the shape of a pair of lungs
Lupin has received FDA approval for its tiotropum DPI • Source: Shutterstock

Lupin has celebrated receiving US Food and Drug Administration approval for its generic version of Boehringer Ingelheim’s Spiriva HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule. The generic will be manufactured at Lupin’s Pithampur facility in India.

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