Blog

The Crucial Role of Project Managers in Selecting a CDMO Partner

March 15, 2024

In the fast-paced and highly competitive landscape of pharmaceutical development and manufacturing, the role of project managers cannot be overstated....

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Blog

On the Journey to Support Drug Developers With End-to-End Outsourcing

October 10, 2023

Mikart, an oral dosage focused contract development and manufacturing organization (CDMO), is moving beyond generic manufacturing to support customers from...

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Blog

Unapproved Drugs Initiative

April 30, 2023

The Unapproved Drugs Initiative (UDI) is a program launched by the Food and Drug Administration (FDA) in 2006 to remove...

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Blog

Phase Appropriate Analytical Method Development and Validation

December 3, 2021

A critical component of the development process for investigational new drugs (INDs) is the establishment of clear, purposeful analytical methods...

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Blog

Our new website has launched

October 29, 2021

We are so pleased to announce the launch of our new website! We are excited to have launched our new...

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Mikart continues to meet the growing demand for the development and manufacturing of controlled substances

June 1, 2021

There continues to be a big need for new molecules of the medical importance of controlled substances that specifically address...

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What does it mean to be 2023 serialization compliant?

February 17, 2021

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…

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What is a powder-in-bottle (PIB) or granules for reconstitution product?

February 9, 2021

The powder-in-bottle (PIB) or granules/powder for suspension approach is used to accelerate formulation development and introduce new chemical entities into...

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Blog

Roller Compaction – Dry Granulation

October 12, 2020

There has been a recent increase in the need for roller compacting in the OSD marketplace. One of the oldest manufacturers...

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Blog

Solvent to Aqueous Switches

June 24, 2020

When I first started my career in the pharmaceutical industry back in 1986, I would find lots of strange looking...

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