Pisgah Labs Inc
Contract manufacturer and developer of active pharmaceutical ingredients (APIs) with over 30 years of experience. Offers integrated R&D, analytical and cGMP manufacturing capabilities across pilot and full-scale suites (up to 2,000 gallons / 8,000 L), with tech-transfer, process scale-up, stability testing and quality assurance support for projects from gram-scale R&D through multi-tonne commercial API production.
Industries
Nr. of Employees
small (1-50)
Patents
Opioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8569330-B1
View DetailsOpioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8569329-B1
View DetailsOpioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8211905-B1
View Detailsconsisting of levothyroxine or liothyronine and an organic acid comprising an aromatic ring having hydroxyl moiety and carboxylic acid moiety in an ortho relationship; uniform and stable oral dosage forms
US-7858663-B1
View Details
Opioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8569330-B1
View DetailsOpioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8569329-B1
View DetailsOpioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties
US-8211905-B1
View Detailsconsisting of levothyroxine or liothyronine and an organic acid comprising an aromatic ring having hydroxyl moiety and carboxylic acid moiety in an ortho relationship; uniform and stable oral dosage forms
US-7858663-B1
View DetailsServices
GMP contract manufacturing of active pharmaceutical ingredients and intermediates, supporting low-kilo to multi-tonne production.
Inter-site tech transfer and process scale-up services from gram-scale R&D to multi-tonne commercial manufacture, with dedicated scientific support.
GMP analytical laboratory services co-located with R&D to provide method development, analytical testing and stability studies to support development and regulatory filings.
Business development services including product development planning, licensing agreements and intellectual property strategy to support commercialization.
GMP contract manufacturing of active pharmaceutical ingredients and intermediates, supporting low-kilo to multi-tonne production.
Inter-site tech transfer and process scale-up services from gram-scale R&D to multi-tonne commercial manufacture, with dedicated scientific support.
GMP analytical laboratory services co-located with R&D to provide method development, analytical testing and stability studies to support development and regulatory filings.
Business development services including product development planning, licensing agreements and intellectual property strategy to support commercialization.
Expertise Areas
- Contract API manufacturing
- cGMP manufacturing
- Tech transfer and process scale-up
- Analytical method development and stability testing
Key Technologies
- Batch chemical synthesis of APIs
- cGMP production suites
- Analytical chemistry and stability study methodologies
- Tech-transfer workflows and scale-up engineering