Alchem Laboratories


Alchem Laboratories Corporation is dedicated to excellence in custom synthesis, process development, and manufacturing of fine organic chemicals and drug substances. They serve pharmaceutical companies, government programs, and clinical trials, providing services from synthesis and analytical development to cGMP manufacturing. Their mission is to be a value-creating partner in drug development, offering innovative solutions, rapid project implementation, and comprehensive support across all stages of drug discovery and production.

Industries

Health Care
Manufacturing
Pharmaceutical
Service Industry
Pharmaceutical Manufacturing

Nr. of Employees

small (1-50)

Alchem Laboratories


Products

Custom Synthesis Services

Design and synthesis of novel compounds and analogs of lead compounds for pharmaceutical development.

cGMP API Manufacturing

cGMP manufacturing of active pharmaceutical ingredients (APIs) and formulations for pre-clinical and clinical studies with batch sizes ranging from several grams to several kilograms.

cGMP Manufacturing of APIs and Drug Products

cGMP manufacturing of APIs and topical, oral, and injectable drug products.

Synthesis of Non-GMP Small Molecules

5-year IDIQ contract with NCI for the synthesis of non-GMP small molecules.

Analysis and Synthesis of GMP and non-GMP Bulk Drugs and Pharmaceutical Formulations

5-year IDIQ contract with NCI supporting bulk drugs and pharmaceutical formulations analysis and synthesis.

Drug Substance and Product Development Services

Comprehensive drug development services including formulation development, CMC documentation, and clinical trial material manufacturing.

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Services

Design and execution of bespoke small-molecule syntheses and analog libraries, from route design through kilogram-scale production.

Optimization and scale-up of chemical processes to pilot and kilogram scale, including process optimization and documentation.

Clinical and pilot-scale cGMP manufacture of APIs and finished dosage forms (topical, oral, injectable), including filling, labeling and packing.

Formulation design and optimization for topical, oral, and injectable products to support preclinical and clinical studies.

Development, transfer and validation of analytical assays for process monitoring, impurity profiling, and product release.

Stability study execution and QC release testing for APIs, intermediates and finished drug products.

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Expertise Areas

  • Custom organic synthesis
  • Process development and scale-up
  • cGMP manufacturing and clinical supply
  • Formulation development for multiple dosage forms
  • Show More (6)

Key Technologies

  • Nuclear magnetic resonance (NMR)
  • High-performance liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Liquid chromatography–mass spectrometry (LC-MS / HRMS)
  • Show More (10)

News & Updates

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