article thumbnail

FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

FDA 218
article thumbnail

Red Sea Shipping Disruptions Don’t Have Pharma Companies Seeing Red Just Yet

MedCity News

Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

article thumbnail

Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water

European Pharmaceutical Review

Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceutical products. The authors noted that the observations were contextualised to “illustrate the amounts of nitrosamine that could be formed from process water during API and drug product manufacture”.

article thumbnail

PDA revises report on glass container manufacturing

European Pharmaceutical Review

43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

article thumbnail

What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.

article thumbnail

Fosun Pharma and IFC to build new drug manufacturing plant in Africa

Pharmaceutical Technology

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.