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.

Commenting on the acquisition, Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited said, “We are excited to announce the acquisition of the Roflumilast tablet ANDA from Breckenridge Pharmaceutical, Inc. This strategic acquisition of Roflumilast Tablet ANDA, for which the manufacturing will be done locally at our US site, expands our portfolio into specialty distribution and also helps us establish a presence in the chronic bronchitis therapy area. This aligns with our strategic focus on identifying and entering a niche, under-penetrated generic formulations with an opportunity to serve the unmet needs in healthcare”

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