Societal CDMO Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has entered into a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe.
 
The new agreement, which is effective immediately and runs through April 2025, establishes Societal as the exclusive supplier of Ritalin LA capsules for the European market through 2023.
 
Societal has a long-standing relationship with Novartis and has served as the company’s exclusive global supplier of Ritalin LA and Focalin XR capsules for approximately 20 years. Novartis recently divested European rights to Ritalin LA capsules to InfectoPharm and this newly signed agreement serves to maintain Societal’ s role as the exclusive supplier of Ritalin LA capsules in Europe.  Societal’s exclusive Manufacturing and Supply Agreement with Novartis for Ritalin LA and Focalin XR capsules for the remainder of the world remains unchanged and continues through 2023. Revenue from Novartis in 2021 represented approximately 24% of Societal’s overall revenue and the company estimates that the Ritalin LA capsules sub-component for the European market represented approximately 30% of its revenues from Novartis. 
 
“Societal has a long history and know-how with Ritalin, dating back to the company’s innovative formulation work that allowed for the creation of an extended-release version of the product. Over the years, we’ve enjoyed an excellent relationship with Novartis while serving as the exclusive global supplier of Ritalin LA capsules,” said David Enloe, chief executive officer of Societal CDMO. “We now look forward to delivering the same high-quality supply and manufacturing services to the InfectoPharm team to support the company’s commercial efforts for the product in the European market.”
 
“This is an important agreement for InfectoPharm as it ensures continuity in the supply chain of Ritalin LA as we work to meet the needs of patients and physicians within the European market. We are particularly pleased to align with a trusted and reliable partner such as Societal CDMO, which achieved on time and in full delivery for the Ritalin LA product in in the past,” stated Philipp Zöller, managing director, InfectoPharm.
 
Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Ritalin LA capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.

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