DEDICATED TO EXCELLENCE IN CUSTOM SYNTHESIS

cGMP manufacturing has been a key component of our business.  Alchem has successfully produced dozens of new APIs and formulations for pre-clinical and clinical studies.

  • Batch sizes from several grams to several kilograms.

  • Production of active pharmaceutical ingredients (APIs) and topical, oral, and injectable products

  • Analytical method development and validation

  • Stability studies for APIs/intermediates and drug products

  • CMC documentation for all stages of drug development

Manufacturing operations performed on a routine basis:  

  • High and low temperature chemistry

  • Pressure reactions

  • Extractions

  • Freeze-drying

  • Column purifications / Flash Chromatography

  • Preparative HPLC

  • Distillations

  • Spray-drying

  • Formulation and component preparation

  • Filling, labeling and packing

  • Development and Clinical Trial Materials (CTM)

  • QC testing and release

The company owns two fully operational facilities located in Alachua, Florida. The floor plan of Building 1 consists of: 

  • Four laboratories for small-scale chemical synthesis

  • cGMP pilot / clinical scale

  • 100L (2) and 50L jacketed reactors

  • 4 foot purification columns

  • 10L and 20L (3) Buchi rotovaps

  • Two laboratories for Analyses/Quality Control

  • Administrative and general storage areas

  • Chemical storage rooms

The floor plan of Alchem's 8,000 sqft commercial cGMP facility (Building 2 at 14120 NW 126 Terrace) consists of: 

  • 2 x 60L and 1 100L Buchiglas jacketed reactors

  • 80L and 130L purification columns

  • 250 to 1000L mixing vessels and CIP

  • Pulse spray dryer

  • QA/QC support / release

  • Shipping / receiving and warehouse