Lupin gets Australian TGA approval for tiotropium powder for inhalation for management of CoPD

Lupin Limited announced that its wholly owned subsidiary in Australia, Generic Health Pty Ltd, has received approval for tiotropium 18 micrograms powder for inhalation in capsules for use with LupinHaler, from the Australian drug regulatory agency Therapeutic Goods Administration (TGA).
 
The power is a bioequivalent version of Boehringer Ingelheim’s Spiriva tiotropium (as bromide monohydrate) powder for inhalation. The product will be manufactured at Lupin’s Pithampur facility in India.
 
Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsules for use with LupinHaler is indicated for the long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD) and for the prevention of COPD exacerbations.
 
“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,” said Dr. Sofia Mumtaz, president – Legal, Canada, Australia, and Japan
 
Tiotropium bromide inhalation powder had estimated annual sales of USD 10 million in Australia, according to an IQVIA report in March, 2023.
 
Mumbai-based Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. It is the third-largest pharmaceutical company in the US by prescriptions. The company invested 7.9% of its revenue in research and development in FY23

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