Senores Pharmaceuticals Acquires ANDA for Roflumilast Tablets

Senores Pharmaceuticals Limited (SPL) has acquired the USFDA-approved Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc., a subsidiary of Towa International. 

This agreement was executed through its wholly-owned US subsidiary, Senores Pharmaceuticals, Inc.

IPO Proceeds Used for Acquisition

The acquisition is being funded through SPL’s IPO proceeds, in line with the company’s previously stated objectives. The transaction, as per the company, aligns with its focus on expanding its speciality distribution portfolio and entering segments with demand for niche, under-penetrated generic formulations.

Roflumilast and Its Market Size

Roflumilast is prescribed for severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis. It is used to reduce the risk of exacerbations in such patients. The US market for Roflumilast is valued at approximately $32 million as per IQVIA (MAT June 2024) and $46 million according to Symphony (MAT September 2024).

Manufacturing in the US

The company has stated that Roflumilast tablets will be manufactured at its US facility. Senores currently operates two formulation manufacturing plants, one in Atlanta, USA (USFDA-approved) and another in Chhatral, India (WHO-GMP approved). 

It also has two API manufacturing sites in India, both located in Ahmedabad.

Operations and Approvals

Senores Pharmaceuticals is engaged in the development and distribution of generic pharmaceuticals across various regulated markets. The company has 24 ANDA approvals and 21 CMO/CDMO commercial products permitted for distribution in the US. It operates in more than 40 countries and has regulatory approvals from over 10 countries for its manufacturing facility in Chhatral.

Market Performance

As of February 21, 9:51 AM, Senores Pharmaceuticals Ltd is trading at ₹555.60, up ₹21.80 (4.08%) today. Since its listing on January 3, the stock has declined by 2.91% overall, but it has gained 9.08% in the past month.

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