Ash Stevens History

Our History

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.


2014

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.

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2012

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.

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2003-2004

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).

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1999

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).

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1998

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.

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1991

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.

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1988

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.

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1988

Ash Stevens Makes AZT for Clinical HIV Studies

Ash Stevens makes larger batches of AZT under NIH government contract for clinical trials (1988)

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1980-1986

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

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1970

Ash Stevens Makes First Clinical Batches

Ash Stevens produces its first GMP API batch for clinical trials for Walter Reed Army Hospital Research Institute.

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1969

Ash Stevens Makes AZT for Cancer Studies

Ash Stevens makes AZT under a NIH government contract.

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1963

First Government Contract Awarded to Ash Stevens

Ash Stevens receives first Government research contract from Walter Reed Army Hospital Institute for Research.

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1962

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.

about ash stevens

Ash Stevens is a full-service pharmaceutical contract manufacturer (CMO) with over five decades of experience developing drug substances & manufacturing active pharmaceutical ingredients.

Ash Stevens Vision

To translate scientific discoveries into medicinal products that improve quality of life.