Ash Stevens was founded in 1962 by Dr. Arthur Ash and Professor Calvin Stevens and is headquartered in Riverview, Michigan. The business was originally founded to provide contract research services to the Federal Government (Walter Reed Army Medical Center, NIH and NCI). While we still provide these services, our primary business today is providing commercial contract drug substance development and API manufacturing services to the Life Sciences industry. The timeline below illustrates the company’s 50+ year path from its early days to the preferred supplier of APIs it is today.
Ash Stevens is a Large Pharma Preferred Supplier
In 2014, Ash Stevens, Inc., a leading provider of global contract pharmaceutical drug substance development and active pharmaceutical ingredient (API) manufacturing services received a 2014 Lilly Global Supplier Award.
Safety #1 at Ash Stevens
Ash Stevens receives its seventh Silver Award over five consecutive years for its commitment to performance improvements in EHS&S from SOCMA’s ChemStewards® program.
CMO leadership Award in Regulatory Category
Ash Stevens received a 2013 CMO Leadership Award in the Regulatory category. The Awards are organized by Life Science Leader magazine using independent industry data gathered by Nice Insight, so it reflects that Ash Stevens ranked in the top 20% out of more than 150 CMOs worldwide based on responses from >10,000 buyers of CMO services.
Capital Allocation for Continuous Improvement in Infrastructure
Ash Stevens completes multi-year, multi-million dollar expansion – adding new capabilities and large-scale capacity at its state-of-the-art cGMP manufacturing facility in Riverview, Michigan.
Contractor to the Federal Government for Over 50 Years
Ash Stevens is awarded its 20th Government contract. Over the years, Ash Stevens has provided research services for many of the drugs developed through the NIH, NCI, and Walter Reed Army Hospital Research Institute.
Ash Stevens Turns 50
Ash Stevens celebrates 50 years in business, transitioning from a small contract government research operation to a preferred supplier of innovator APIs for both small and large Life Sciences companies.
Twelfth NCE / API Manufacturing Approval
Ash Stevens Inc. receives its 12th innovator (NCE) API manufacturing approval for the FDA fast-track drug, Ponatinib (Icusig®). The pre-approval Inspection for this comprehensive QbD filing yielded no observations on a FDA Form 483.
Three Concomitant FDA Fast-Track Manufacturing Approvals
Ash Stevens receives three FDA manufacturing approvals in less than two years for the fast-track cancer drugs Bortezomib (Velcade® – May 2003 approval), Clofarabine (Clolar® – Dec 2004 approval) and Azacitidine (Vidaza® – May 2004 approval).
Highly Potent API (HPAPI) Approval
Ash Stevens receives FDA manufacturing approval for the Highly Potent API, Busulfan (Busulfex®), a non-specific alkylating antineoplastic agent used as a part of the conditioning regime for bone marrow transplantation to treat chronic myeloid leukemia (CML).
Early Player in High Potency Manufacturing
Ash Stevens Inc. purchases one of the first Walker-Carlisle barrier isolation systems designed for isolation, drying, and packaging of HPAPIs.
NCI Work Leads to First Approval
Ash Stevens receives its first FDA manufacturing approval for Fludarabine Phosphate – a treatment for hematological malignancies. Ash Stevens’ early NCI work led to the commercial contract for manufacturing the approved API.
Ash Stevens Builds New Manufacturing Facility
Ash Stevens builds a new GMP manufacturing facility in Riverview, Michigan that houses research laboratories, quality control labs, full-scale production areas, offices, and amenities.
Ash Stevens Makes AZT for Clinical HIV Studies
Ash Stevens makes larger batches of AZT under NIH government contract for clinical trials (1988)
Ash Stevens Receives Multiple NIH Contracts
Ash Stevens receives four contracts from the NIH for the preparation of Anti-Cancer Drugs for pre-clinical and clinical evaluation
Ash Stevens Makes First Clinical Batches
Ash Stevens produces its first GMP API batch for clinical trials for Walter Reed Army Hospital Research Institute.
Ash Stevens Makes AZT for Cancer Studies
Ash Stevens makes AZT under a NIH government contract.
First Government Contract Awarded to Ash Stevens
Ash Stevens receives first Government research contract from Walter Reed Army Hospital Institute for Research.
Ash Stevens Founded
Ash Stevens founded by Dr. Arthur Ash (doctorate in Chemistry from Wayne State University under the direction of Nobel Laureate Professor Herbert C. Brown) and WSU Chemistry Professor Dr. Calvin Stevens.