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Grace and Formac Pharmaceuticals have announced SilSol 6035 Mesoporous Silica Gel, the first silica in the Grace silica-based drug delivery platform. The silica gel is the result of a multi-year collaboration between the companies.The platform was engineered to offer a new drug delivery option for APIs with poor aqueous solubility (BCS class 2 compounds), Grace reports and combines the company’s expertise in mesoporous silica gel and novel application methods to accelerate the screening and development of stable, amorphous-based systems.

Grace Announces Silica-based Drug Delivery Platform

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Safer solid reagents and new coupling chemistry are important developments.

Advances in Fluorination Chemistry for API Synthesis

BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.

BASF Closes Sale of Custom Synthesis Business

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

Hovione Expands Drug Substance Manufacturing

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

Process Improves the Bioavailability of Active Ingredients

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

EMD Millipore Provides Risk-Assessment Information for Raw Materials

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

FDA Cites India API Facility For CGMP Violations

Lisa has a PharmD. ad M.P.H, and is a consumer safety officer at FDA. She can be reached at Lisa.Tung@fda.hhs.org.

Maria Eng is a behavioral epidemiologist and adjunct professor at Johns Hopkins University. She has a Phar.D. and M.P.H. degrees.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

Lessons Learned from FDA Inspections of Foreign API Facilities

More complex drug candidates require more specialized and selective chemistry.

Going Low Temperature

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.