Year Founded: 1962
Stephen Munk, Ph.D.
President & CEO
Vice President, Operations
James Hamby, Ph.D.
Vice President of Business Development
Ash Stevens is a global provider of contract active pharmaceutical
ingredient (API) development and manufacturing services. With
more than 50 years of experience, the company has achieved an
impressive track record of fourteen FDA manufacturing approvals
for innovator APIs (all NCEs) including multiple API approvals
for FDA fast-tracked drugs developed under significantly
accelerated timelines. Ash Stevens’ business model is predicated
on providing Sponsor clients with the safest and highest quality
work product possible while meeting delivery obligations on
time and on budget.
Ash Stevens serves the worldwide Life Sciences industry seeking
to outsource the development and manufacture of innovator
small-molecule APIs. Ash Stevens state-of-the-art manufacturing
facility in Riverview, Michigan has the capability to manufacture
APIs from gram quantities to hundreds of kilos including highly
potent active pharmaceutical ingredients (HPAPIs).
Process Research & Development
Process research, development, and route optimization are core
competencies at Ash Stevens. The company has a dedicated
staff of professional process chemists (predominately PhDs)
and engineers with substantial experience and expertise in the
development of robust chemical processes that can be executed
under cGMP control.
Ash Stevens has a long-standing track record and reputation as
a preferred supplier of innovator APIs. The company is a fully
integrated pharmaceutical contract manufacturer supporting all
aspects of drug substance development and manufacturing, from
de novo process development to commercial API production
including quality by design (QbD) process risk assessments and
Ash Stevens has a dedicated and experienced professional
analytical team that provides broad in-house analytical support
for the development and manufacture of APIs. Services include
phase appropriate analytical method development, qualification,
and validation, as well as, forced degradation studies, stability
testing, and reference standard qualification.
Regulatory Compliance & Support
Ash Stevens is a fully cGMP-compliant operation with a successful
global regulatory compliance and inspection history that includes
inspections by the US FDA, Australia, European Union, Mexico,
Korea, Japan, and Russia. Ash Stevens products are distributed
worldwide. The company provides regulatory and document
support for all regulatory filings (DMFs, INDs, NDAs, and CTD).
18655 Krause Street
Riverview, MI 48193 USA
Tel: +1 734-282-3370
Fax: +1 734-282-5388
A Division of Piramal Pharma Solutions