CMC Pharmaceuticals, Inc. is a Solon-based drug development company that helps turn small-molecule candidates into manufacturable, submission-ready medicines through integrated CMC science, laboratory work, and regulatory support. Its FDA-inspected, cGMP-compliant laboratories and in-house pilot plant support development from early formulation through scale-up, while its RAMP program produces small prototype batches for preclinical and feasibility studies. Unlike a conventional testing lab or CDMO, CMC Pharma remains involved in selecting and overseeing external GMP manufacturers rather than operating a commercial GMP manufacturing facility of its own.
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FDA Inspection: No Action Indicated
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Vici Health SciencesFounded by pharmaceutical scientists Anish Dhanarajan, Ph.D., and Francesca Minale, Vici Health Sciences is a Maryland-based research and development company known for helping small and emerging pharmaceutical firms move drug candidates toward the clinic and market. Its scientists combine formulation expertise with practical experience in clinical-supply manufacturing and FDA regulatory work, and the company reports more than 50 formulations developed, involvement in over 30 clinical trials, and more than 15 ANDAs submitted and approved.ELKRIDGE, MD
Pharmaceutics International, Inc. (Pii)Founded in 1994, Pharmaceutics International, Inc. (Pii) is a Hunt Valley drug product contract development and manufacturing organization that takes pharmaceutical products from early development through clinical trials and commercial production. Now part of Jabil, Pii combines more than 30 years of complex-formulation experience with a 360,000-square-foot, four-site campus and more than 300 scientists and support staff. Its GMP facilities are built for demanding work, including potent compounds, complex injectables and oral drug products, with FDA-licensed and DEA-registered operations.HUNT VALLEY, MD
Ajinomoto Bio-Pharma ServicesWith more than 40 years in small-molecule manufacturing, Ajinomoto Bio-Pharma Services develops and produces pharmaceutical APIs and intermediates for drug companies worldwide. Its CDMO capabilities span the path from preclinical work through commercialization, while on-site analytical laboratories characterize molecules and support quality testing throughout their life cycle. Through Forge Biologics, a member of Ajinomoto Bio-Pharma Services, the company also provides AAV and plasmid manufacturing from preclinical through commercial stages.COLUMBUS, OH
Pharmaceutical Manufacturing Research Services, Inc. (PMRS)Founded by Edwin R. Thompson in 1994, privately held PMRS develops and contract-manufactures pharmaceutical products from clinical supply through commercial production, with analytical and quality support under one roof. The Horsham company has grown from six employees to about 30 and has completed more than 550 projects, supporting four NDA-approved commercial products, an internationally approved product, and developmental drugs. Its 130,000-square-foot custom facility and hands-on, cross-functional staff reflect a model in which every team member is involved in each project.HORSHAM, PA