AMPAC Analytical (AA) supports all analytical requirements for pharmaceutical intermediates, Active Pharmaceutical Ingredients and formulated drug product. From Analytical Method Development and Implementation to Analytical Method Validation and stability, AMPAC Analytical is fully equipped with fully compliant cGMP instrumentation geared toward product analysis and product release. AAL supports spectroscopy, chromatography, particle size distribution, calorimetry, osmolality, mass spectrometry and ICH Stability project requirements.
AMPAC Fine Chemicals (AFC) manufactures active pharmaceutical ingredients (APIs) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities are located in Rancho Cordova, California, approximately 20 miles east of downtown Sacramento, and in La Porte, Texas, approximately 28 miles east of Houston. AFC also has a 3rd development / commercial cGMP manufacturing facility located in Petersburg, Virginia, approximately 25 miles south of Richmond, Virginia.
AMPAC Fine Chemicals has more than 70 years of experience in mastering challenging chemistries. It has developed capabilities that support a wide range of processes and technologies during that time. All of AFC’s products are manufactured in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP).
AFC has supplied full support of API production, including all analytical requirements from analytical method development to drug substance stability. It was AFCs decision to expand all analytical capabilities to a dedicated analytical facility located in El Dorado Hills, California, approximately 25 miles east of downtown Sacramento, neighboring AFCs Rancho Cordova cGMP manufacturing facility. This facility is AMPAC Analytical.