Albany Molecular Research, Inc. (AMRI) has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s recently approved acne treatment, Winlevi (clascoterone) cream 1%.
 
The U.S. FDA approved Winlevi (clascoterone) cream 1% in August 2020, marking a significant milestone in the treatment of acne vulgaris in patients 12 years and older. The FDA last approved an acne drug with a new mechanism of action about 40 years ago.¹
 
“AMRI was chosen as the exclusive supplier for the API because of its outstanding expertise in steroid and hormone development and manufacturing,” said Teresa Pallotta, vice president, API sales, AMRI. “Our team is pleased to support Cassiopea in providing this novel treatment for acne. We take pride in our customer intimacy approach, which ensures that we are in tune with their specific needs and drives our commitment to the highest level of customer service.”
 
Diana Harbort, chief executive officer, Cassiopea, said, “We are pleased to work with the AMRI team in Spain to establish ongoing supply for the API for Winlevi. AMRI’s quality, reliability, and expertise in the development and manufacture of APIs are key to helping us to provide this innovative treatment and to help improve the quality of life for those suffering from acne.”
 
Winlevi, a first-in-class topical androgen receptor inhibitor, is expected to be available by prescription only in the U.S. in the first quarter of 2021. Complete prescribing information is available at www.winlevi.com.
 
1. https://www.cassiopea.com/wp-content/uploads/2020/08/200827_Cassiopea_Winlevi_FDA-Approval_ENG.pdf