Senores Pharmaceuticals expands US footprint with Roflumilast ANDA acquisition

Senores Pharmaceuticals Limited has taken a significant step in its US expansion strategy by acquiring an Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc., a US subsidiary of Towa International. The acquisition, made through its wholly owned US subsidiary, Senores Pharmaceuticals, Inc., is set to strengthen its presence in the chronic obstructive pulmonary disease (COPD) treatment market.

Roflumilast, a phosphodiesterase-4 inhibitor, is used to reduce the risk of COPD exacerbations in patients with severe chronic bronchitis and a history of flare-ups. The US market for Roflumilast was valued at approximately $32 million (MAT June 2024), according to IQVIA, and $46 million (MAT September 2024) based on Symphony data.

Senores Pharmaceuticals strengthens chronic disease treatment portfolio

The acquisition aligns with Senores Pharmaceuticals’ strategic focus on specialty drug distribution and under-penetrated generic formulations. The company plans to manufacture the Roflumilast tablets at its US-based manufacturing facility, which is USFDA-approved and compliant with DEA and BAA standards.

According to Swapnil Shah, Managing Director of Senores Pharmaceuticals, the deal marks a significant milestone in the company’s growth strategy. He emphasized that acquiring the Roflumilast ANDA would not only expand the company’s US product portfolio but also allow it to establish a stronger foothold in the chronic bronchitis therapy segment.

Funding from IPO proceeds supports strategic expansion

The acquisition is funded through proceeds from Senores Pharmaceuticals’ Initial Public Offering (IPO), aligning with the objectives outlined in its Red Herring Prospectus. The company continues to reinvest in key therapeutic segments to address unmet healthcare needs in both the US and emerging markets.

Senores Pharmaceuticals’ US market expansion is part of its broader effort to diversify its generic drug portfolio, particularly in complex generics. The company currently has 24 approved ANDAs and 21 CMO/CDMO commercial products available in the US market. Additionally, it operates across more than 40 countries, supplying pharmaceutical products through its Chhatral and Naroda manufacturing facilities in India.

Senores Pharmaceuticals’ growing global presence

Beyond the US, Senores Pharmaceuticals is expanding in Canada and other regulated and emerging markets. The company’s two API manufacturing plants in India support its complex generic drug production, while its research and development capabilities span three R&D sites in the US and India.

With over 260 product registrations and 530 applications, the company continues to strengthen its position as a leading global pharmaceutical manufacturer. Its expertise in critical care injectables and active pharmaceutical ingredients (API) further enhances its ability to compete in specialized drug markets.

The future of Senores Pharmaceuticals in the US market

With the Roflumilast ANDA acquisition, Senores Pharmaceuticals is poised to enhance its presence in the US respiratory drug market, tapping into the demand for effective COPD treatments. The company’s strategic investments in specialty drug distribution and niche generics reinforce its ambition to become a key player in the global pharmaceutical industry.

As Senores Pharmaceuticals continues to execute its expansion strategy, its focus remains on driving innovation, securing regulatory approvals, and delivering high-quality generic medicines to patients worldwide.