02.28.25 -- CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

Enzalutamide and apalutamide, used for advanced prostate cancer, are not druggable in their crystalline form due to low solubility, so they are marketed as amorphous solid dispersions. Join on March 12th to learn how Nanoforming these drugs into high-load nanocrystals can reduce pill size, enhance performance, and extend market exclusivity while benefiting patients.

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

On the journey toward creating effective therapies, the development of a rugged method for optimizing small molecule drug development strategies plays a pivotal role.

A CDMO that has expertise and resources in softgel formulation can help companies address stability issues, improve drug bioavailability, or ensure compliance with regulations.

Explore why it is important to classify HPAPIs, how they are evaluated, how HPAPI facilities are qualified, and strategies to ensure containment and safety when handling HPAPIs.

Here, we describe the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

In an industry where quality can be a matter of life and death, investing in robust, digital quality management systems is the key to ensuring product safety, maintaining compliance, and fostering trust.

Review our innovative nanoparticle technology and consider the value it can bring to molecules in development or products on the market for neurological disorders such as ADHD.

With over 40 years of experience and a growing team of over 2,100 experts, we are a trusted partner in branded and generic markets for API and dosage form development and manufacturing.