Lupin gets Health Canada approval of Tiotropium Bromide

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Global pharma major Lupin Limited announced that its Canada subsidiary, Lupin Pharma Canada Ltd., has received approval from Health Canada to market a generic version of Spiriva® (tiotropium bromide inhalation powder) for the treatment of chronic obstructive pulmonary disease (COPD), in Canada.

Tiotropium Bromide Inhalation Powder is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also used to relieve wheezing, shortness of breath, coughing, and chest tightness in patients with COPD.

“This approval of the first generic for Tiotropium Bromide Inhalation Powder by Health Canada underscores our commitment to bring affordable options of complex products for patients in Canada, particularly in the respiratory therapeutic area,” said, Dr. Sofia Mumtaz, President – Legal, Canada, Australia, and Japan

Tiotropium Bromide Inhalation Powder (RLD Spiriva®) had estimated annual sales of USD 42 million in Canada (IQVIA MAT Q4 of 2022).

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