Lupin's subsidiary, Generic Health gets Tiotropium 18 micrograms approval

Major pharma company Lupin Limited (Lupin) announced on Wednesday, July 26 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, which is bioequivalent of SPIRIVA tiotropium, the company informed in a BSE filing. The company has received the approval from Therapeutic Goods Administration (TGA).

This product will be manufactured at Lupin's Pithampur facility in India, the company said. Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsules for use with LupinHaler can be used for the long-term maintenance treatment of bronchospasm and dyspnea, which is associated with chronic obstructive pulmonary disease (COPD) and for the prevention of COPD exacerbations.

Speaking about the approval, the President of legal matters, Canada, Australia, and Japan, Dr Sofia Mumtaz said, “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."

Annual sales of Tiotropium Bromide Inhalation Powder stood at about $ 10 million in Australia and the recent approval is likely to benefit Lupin's business in the country.

Lupin Limited is an Indian multinational pharmaceutical company based in Mumbai. It is one of the largest generic pharmaceutical companies by revenue globally.