Prasco Laboratories, Inc. is an American contract development and manufacturing organization (CDMO) that provides pharmaceutical development, formulation, and manufacturing services, primarily to companies in the generic drug sector. The firm operates facilities in the United States and offers capabilities that span the drug development continuum, from pre‑clinical formulation work through commercial production.
Overview
Prasco Laboratories supplies a range of services, including analytical testing, process development, scale‑up, clinical trial material production, and commercial manufacturing of oral solid‑dose dosage forms such as tablets and capsules. The company positions itself as a partner for pharmaceutical and biotechnology firms seeking to outsource parts of the drug development and supply chain processes.
History
The company was founded in the early 2000s, with publicly available sources indicating a founding year of 2008. Its headquarters are located in the state of Ohio, United States. Since its inception, Prasco Laboratories has expanded its manufacturing capacity and client base, establishing multiple production sites to support domestic and international customers.
Services and Capabilities
| Service Category | Description |
|---|---|
| Formulation Development | Design and optimization of tablet, capsule, and other oral dosage forms, including excipient selection and stability testing. |
| Analytical Services | Bio‑equivalence, dissolution, content uniformity, and other regulatory‑required testing. |
| Clinical Trial Material Production | Manufacture of small‑scale batches for Phase I‑III clinical studies, adhering to Good Manufacturing Practice (GMP) standards. |
| Commercial Manufacturing | Large‑scale, FDA‑registered production of generic drug products for market launch and sustained supply. |
| Regulatory Support | Assistance with FDA submissions, filing of Abbreviated New Drug Applications (ANDAs), and compliance documentation. |
Facilities
Prasco Laboratories maintains FDA‑registered manufacturing facilities equipped for high‑volume tablet and capsule production. The sites incorporate modern process‑control technologies and quality‑management systems designed to meet current Good Manufacturing Practice (cGMP) requirements.
Market Role
Within the U.S. generic pharmaceuticals market, Prasco Laboratories is recognized as a midsized CDMO that enables smaller and mid‑size pharmaceutical companies to bring generic products to market without the need for extensive in‑house manufacturing infrastructure. The company’s services are leveraged to reduce development timelines and mitigate the financial risks associated with bringing new generic drugs to market.
See also
- Contract development and manufacturing organization (CDMO)
- Generic drug industry in the United States
- Good Manufacturing Practice (GMP)
References
Information compiled from publicly available corporate disclosures, industry publications, and the company’s official website.