Specialty Generics

Who We Are

Founded in St. Louis, Missouri more the 150 years ago, Mallinckrodt’s Specialty Generics business unit is the largest domestic producer of active pharmaceutical ingredients (APIs) and the only large-scale manufacturer in the United States capable of producing essential medicines, from starting material to finished dose. Our technical capabilities, combined with our commitment to quality and integrity, help ensure people have access to affordable prescription drugs they can trust. Everything we do is grounded by our vision statement.

What We Do

As a manufacturing leader in the US generics industry, we are focused on meeting patient’s needs today and advancing our growing portfolio of complex generic pharmaceuticals and active pharmaceutical ingredients to help treat a greater set of patient needs in the future.

Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients. Through our unique, vertically integrated network, we control every step of product development – from active ingredient processing, through formulation, manufacturing, packaging, and distribution. This process allows us to provide a reliable U.S. based source of supply, assure product quality, and remain competitive in the marketplace.

With one of one of the nation’s most diverse product portfolios, we offer a broad range of generics products with an emphasis on pain management, substance abuse and ADHD, and a comprehensive line of APIs which include Acetaminophen/Paracetamol, DEA scheduled substances, and stearates.

Mallinckrodt has built a worldwide reputation for high-quality products. Our robust new product pipeline leverages our competitive advantages and is expanding into other essential medicines and high-value products. The Specialty Generics organization possesses extensive technical ability, cutting-edge technologies and a highly trained workforce. We are continually investing in our processes, plants and people.

A large majority of the United States’ essential medications, including leading antibiotics, antivirals and COVID-19 medicines have no or only a single US-source for active pharmaceutical ingredients (APIs), which are the essential materials needed for medicines. Absence of domestic supply for active API and finished dosage medications puts our country’s pharmaceutical supply and public health at risk.

Mallinckrodt strongly supports the bi-partisan effort by the US Congress and the Biden Administration to advance policy, legislation and appropriations to re-shore and strengthen the US pharmaceutical supply. Mallinckrodt is uniquely suited to help strengthen the US pharmaceutical supply chain with its five US-based manufacturing sites and the capability to manufacture both API and finished dose medicines. We are also the only large-scale domestic vertically integrated manufacturer, from starting material to finished dose pharmaceuticals.

Logical Partner Reduce US Dependence on Foreign APIs Plant Expansion

What We Believe In

For more than 150 years, we have remained focused on producing quality pharmaceutical products and ingredients with the utmost integrity and unparalleled service in order to better serve the patients, customers and communities in which we live and work. 

MAT Access

Medication-Assisted Treatment (MAT) with counseling and behavioral therapy, has been shown to be the most effective treatment for opioid use disorder, particularly for sustaining long-term recovery.^{1, 2} As such, Mallinckrodt supports policies that ensure all patients with a substance use disorder have access to appropriate treatment, including counseling, behavioral therapy and appropriate medication. Moreover, barriers to treatment access at the federal and state levels should be eliminated, particularly in our country’s correctional systems and jails.  In 2018, Pew Charitable Trusts revealed that less than 1% of jails and prisons nationwide allow access to the full range of FDA-approved MAT products.³

Philanthropy

As part of our mission, we are committed to strengthening the communities in which our employees live and work. From our headquarters to our operating sites around the world, Mallinckrodt's philanthropic activities strive to advance society in meaningful ways. We recognize the importance of employee community involvement to our corporate citizenship efforts. Through our matching gift and employee volunteer program, we encourage and reward employees who personally contribute their time and money to causes.

1. https://www.cms.gov/Outreach-and Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf.
2. https://www.thenationalcouncil.org/mat/
3. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2018/04/04/new-momentum-for-addiction-treatment-behind-bars