API Manufacturing

Sekisui XenoTech's global team utilizes our expertise in optical resolution for amino acid production to provide GMP-compliant, FDA/JP/EDQM-inspected, contract manufacturing of new investigational drugs, active pharmaceutical ingredients (APIs) and pharmaceutical intermediates. 

Our multi-purpose cGMP facility is capable of both water-based and organic solvent-based manufacturing to meet any reaction and treatment needs with quality assurance testing and cutting-edge equipment. Our Research & Development team can quickly and consistently support manufacturing of grams to couple of kilograms, pilot-scale manufacturing, up to industrial-scale manufacturing.

Amino Acid Synthesis
DL-amino acids are synthesized via hydantoin intermediates as precursors. Using these synthesized DL-amino acids, we have established a method to isolate L-amino acids or D-amino acids by enzymatic or chemical optical resolution. We even synthesize unnatural amino acids, using a wide variety of chemical compounds as a precursor. Protected amino acids and α-aminocarboxamide are produced by processing these varieties of amino acids, as well as diverse derivatives via halogenation, reduction, and other processes. Moreover, we have manufactured ton-level peptide compounds via liquid phase method.

Some of the active pharmaceutical ingredients and intermediates within Sekisui XenoTech's expertise include:
  • Active Pharmaceutical Ingredients (APIs)
    • γ-Aminobutyric Acid (Brain metabolic stimulant)
    • ε-Aminocaproic Acid (Antiplasmin agent)
    • Chlorobutanol (1,1,1-Trichloro-2-methyl-2-propanol, Chloretone; Antiseptic)
    • Clemastine Fumarate (Antihistaminic)
    • Gabexate Mesilate (Therapeutic drug for pancreatic disease or DIC, disseminated intravascular coagulation syndrome)
  • D-Amino Acids (made-to-order pharmaceutical intermediates)
    • D-Valine
    • D-Tryptophan
    • D-Phenylalanine
    • D-Methionine
    • D-Biphenylalanine
    • D-Cyclohexylalanine
    • D-Cyclohexylglycine
    • D-Tyrosine
    • D-m-Tyrosine
    • D-6-Hydroxynorleucine
    • D-Leucine
  • L-Amino Acids (made-to-order products for use in pharmaceuticals, etc.)
    • L-Leucine
    • L-Methionine
    • L-Valine
  • N·C-Protected Amino Acids (made-to-order products)
    • N-Acyl-Amino Acid
    • N-Carbamoyl-Amino Acid
    • Amino Acid Alkyl Ester
    • Amino Acid Benzyl Ester
    • Aminocarboxamide
  • Special Amino Acids (made-to-order pharmaceutical intermediates)
    • L-Allysine ethylene acetal
    • L-Cyclohexylglycine
    • L-m-Tyrosine
    • L-Norvaline
    • L-6-Hydroxynorleucine
    • L-4,4’-Biphenylalanine
    • (S)-Isoserine
    • 1-Amino-Cyclopenetanecarboxylic acid (Cycloleucine)
  • GMP manufacturing for Peptides using cutting edge Liquid Phase Peptide Synthesis Molecular Hiving™ technology, featuring:
    • Simple monitoring: direct analysis can be held in each process
    • High purity and High yield: easy separation and purification in each steps
    • Efficient manufacturing: easy scale -up and application to fragment condensation

If you do not see a compound listed above, please contact us to inquire about contract manufacturing availability.
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