Senores Pharma buys USFDA approved ANDA for COPD drug
Ahmedabad: Senores Pharmaceuticals Limited, through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA, has signed an agreement to buy the USFDA-approved Abbreviated New Drug Application (‘ANDA’) for ‘Roflumilast’ 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc., a U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States.
Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis and a history of exacerbations.
The market size of Roflumilast in the USA was ~USD 32 Mn (MAT June 2024) as per IQVIA and ~USD 46 Mn (MAT September 2024)# as per the specialty data aggregator Symphony.
The acquisition will be funded through the Initial Public Offer (‘IPO’) proceeds raised by SPL. This is in line with the Objects of the IPO stated in the Red Herring Prospectus.
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