Unapproved Drugs Initiative
The Unapproved Drugs Initiative (UDI) is a program launched by the Food and Drug Administration (FDA) in 2006 to remove...
Phase Appropriate Analytical Method Development and Validation
A critical component of the development process for investigational new drugs (INDs) is the establishment of clear, purposeful analytical methods...
Our new website has launched
We are so pleased to announce the launch of our new website! We are excited to have launched our new...
Mikart continues to meet the growing demand for the development and manufacturing of controlled substances
There continues to be a big need for new molecules of the medical importance of controlled substances that specifically address...
What does it mean to be 2023 serialization compliant?
Mikart is 2023 compliant, offering unit-level traceability and aggregation from the lowest unit of sale to the pallet. Although aggregation is only expected to become mandatory and fully applied in…
What is a powder-in-bottle (PIB) or granules for reconstitution product?
The powder-in-bottle (PIB) or granules/powder for suspension approach is used to accelerate formulation development and introduce new chemical entities into...
Roller Compaction – Dry Granulation
There has been a recent increase in the need for roller compacting in the OSD marketplace. One of the oldest manufacturers...
Solvent to Aqueous Switches
When I first started my career in the pharmaceutical industry back in 1986, I would find lots of strange looking...