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Lupin’s tiotropium bromide DPI approved in Australia

According to Lupin, the company’s generic version of Boehringer Ingelheim’s Spiriva Handihaler tiotropium bromide DPI has been approved for the treatment of COPD by Australia’s Therapeutic Goods Administration (TGA). Lupin said that it will manufacture the inhalation powder at its plant in Pithampur, India.

The company’s generic version of Spiriva Handihaler has previously been approved in the UK, Canada, and the US.

Lupin President, Legal, for Canada, Australia, and Japan, Sofia Mumtaz commented, “We are pleased to have received the approval for bioequivalent tiotropium dry powder for inhalation from TGA for the treatment of COPD in Australia. This will provide a high-quality and low-cost treatment option to healthcare professionals in Australia for the treatment of COPD. This approval is an important milestone in our commitment to enable access to medicines and offer affordable options of complex generics for patients in Australia, particularly in the respiratory therapeutic area.”

Read the Lupin press release.

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published on July 27, 2023

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