Accelerating Product Development with Mikart’s Non-GMP Small-Scale Laboratory In the highly competitive pharmaceutical industry, speed is everything. The faster a...
Sailing Smoothly: Partnering with a CDMO for Liquid-Oral Formulation Development
Liquid-oral formulations, from solutions to syrups, come with their fair share of complexities. Think solubility woes, stability concerns, and taste...
The Crucial Role of Project Managers in Selecting a CDMO Partner
In the fast-paced and highly competitive landscape of pharmaceutical development and manufacturing, the role of project managers cannot be overstated....
On the Journey to Support Drug Developers With End-to-End Outsourcing
Mikart, an oral dosage focused contract development and manufacturing organization (CDMO), is moving beyond generic manufacturing to support customers from...
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...