Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients

The Active Pharmaceutical Ingredient (API) is the part of any drug that produces the intended effects.
Custom services include:

• Custom synthesis of Active Pharmaceutical Ingredients and advanced intermediates
• Process development/scale-up
• Process validation
• Stability testing
• Test method development and validation
• Clinical Trial Material (CTM) and supporting documentation
• Drug Master File (DMF) development and maintenance

Working closely with clients ranging from virtual pharmaceutical companies to the world’s largest multinational pharmaceutical and biopharmaceutical producers, we synthesize proprietary and commercial compounds in quantities ranging from grams to kg. 

Key product technologies:

High Potency Substance manufacturing in a certified development and commercial scale multi-purpose containment chemistry manufacturing facility
Sterile Injectable Grade Lactate salt solutions
In everything we do, motivated by a concern for both product quality and environmental /worker safety. We design and equip our plant, write our procedures and train our people to meet or exceed stringent regulatory protocols and international regulatory and multi-compendial standards.