35 approved Abbreviated New Drug Applications (ANDA) in the United States
19 commercialized drug products in the United States
Proven track record for developing complex injectables in multiple dosage forms
Expertise in sterile liquids, lyophilized vials, prefilled syringes, and dry powder injections
Description
With over 25 years of domain experience in sterile injectables, we can leverage our deep expertise in formulation and analytical development, all the way to optimization, scale-up and transfer of lyophilization cycles.
Certificates
FDA
MHRA
ANVISA
TGA
WHO
MCC
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