Founded in 1979, Pisgah Labs has remained a privately held corporation whose longevity and success are attributable to the conservative principles personified by its founder and CEO, Bill Bristol. At its inception, the Company began manufacturing high value-added intermediates principally supporting R&D efforts. These activities led to additional business in larger scale custom and fine chemical manufacturing. Concurrently, the Company began developmental and manufacturing activities for major multi-national corporations. By the mid-1980s, Pisgah Labs was sufficiently financially grounded to embark upon its first significant business and facilities expansion.

In the early 1990’s the business conditions for the U.S. fine chemical industry clearly indicated the business Pisgah enjoyed would be under attack from offshore competition. In an effort to stave off this encroachment, Pisgah Labs invested in new state-of-the-art manufacturing suites for the production of Active Pharmaceutical Ingredients (API) and subsequently began manufacturing commercially released APIs in 1996. The Company quickly advanced its GMP contract manufacturing arm and became identified as a manufacturer of APIs for injectable products.

With well established technical resources and API manufacturing capability, the Company successfully engaged in partnerships to develop solid oral dose and injectable products (ANDAs). Through these efforts the Company’s facility capabilities expanded to include an aseptic manufacturing suite supported by the appropriate microbiological testing laboratory.

While contract API manufacturing and revenues from product participation continue, the Company has invested heavily in the development of proprietary and patented technology. While it is very clear the global economy threatens the financial fundamentals of the US pharmaceutical industry, Pisgah’s response to this challenge has been to develop intellectual property platforms applicable to a host of drug products. Using its core strength in chemistry, Pisgah has filed patents on system technologies for imparting anti-abuse, controlled and modified release, and anti-counterfeiting properties to a variety of drug substances. An integrated approach to business opportunity, market understanding, regulatory compliance, manufacturing capability and intellectual property has placed Pisgah Labs in a unique position within the pharmaceutical industry. Ultimately, Pisgah’s capability provides its partners and clients with excellent patent protected product development and licensing opportunities.