Pisgah Labs P2P INTERVENTIONS™ Mission:
Pisgah Labs and P2P INTERVENTIONS™ is committed to improving medically necessary pain medications that contain Active Pharmaceutical Ingredients (APIs) that by their design dramatically impede illicit drug use.
With our success, the intersection of chemistry and healthcare will yield a broad range of controlled substance pharmaceuticals possessing performance enhancing features which thwart drug abuse and lessen a product’s abuse potential and appeal to would-be addicts.
About Pisgah Labs and P2P INTERVENTIONS™
|1979||Founded and privately owned by Bill Bristol. Bill remains President and CEO.|
|1980′s||We focused on large-scale custom and fine chemical manufacturing for major multi-national corporations.|
|1990||Evolving with the pharmaceutical industry, we constructed state-of-the-art manufacturing suites to focus on the production of active pharmaceutical ingredients (APIs)|
|1996||We produced the first round of commercialized APIs. Continued success meeting customer needs allowed us to further expand our capabilities by producing injectable-grade APIs for the fast emerging generic injectable business model.|
|2000||We were well positioned technically and financially to engage in successful co-development agreements on both oral and injectable ANDAs. To better support our business partners, we expanded aseptic manufacturing capabilities and microbiological testing.|
|2003 – 2004||We identified needs in the pharmaceutical market place to guide our intellectual property program.|
|2004 – present||We successfully filed 10 patent applications covering technology in more than a dozen pharmaceutical areas of need.|
From Active Ingredient to Branded Product – At Pisgah Labs, we have 3 Key Commitments:
We Use Chemistry to Change the Technology Paradigm – While we continue to look for ways to mediate drug abuse, our manufacturing know-how in concert with our understanding of the challenges faced by the pharmaceutical industry mean that we attack problems with smart and creative chemistry from a business perspective.
We Practice Quality Manufacturing – Manufacturing is an elemental part of our history and is bedrock to our business. Pisgah Labs is a drug substance manufacturing facility which is FDA-inspected, employs state-of-the-art equipment and operates according to the current Good Manufacturing Practices (cGMP).
We Embrace Partnerships – We continuously seek opportunities to work with established businesses, entrepreneurs, and government agencies to advance pharmaceutical performance. We understand that the combination of technology and branding leads to success in the marketplace.
Capabilities of Pisgah Labs and P2P INTERVENTIONS™:
Whether you need contract manufacturing or an implementation of your company’s platform technologies, Pisgah Labs has a wide range of capabilities:
- Capacities ranging from glassware through 2000 gallon equipment;
- Fully validated reactor trains designed according to a suite concept where each suite is maintained as a controlled environment with dedicated HEPA filtration;
- Three multi-purpose suites to accommodate the variable needs of a dynamic marketplace;
- Multi-ton large scale manufacturing available for extensive or lengthy syntheses;
- Aseptic API manufacturing available at the 50 gallon scale; if needed, the design features of larger equipment suites are available for aseptic validation;
- Production supervision and QA oversight rigorously monitor our operations for compliance to cGMP standards through written SOPs, protocols and batch sheets;
- Production documentation, particularly during a project’s validation stage, is thoroughly integrated with the development process to meet the requirements for successful regulatory submissions (DMFs, ANDAs and / or NDAs);
Our approach has produced a successful FDA compliance history covering continuous compliance audits (cGMP) and Pre-Approval Inspections (PAI).