Topic

Articles

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

HHS Announces Restructuring

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.

Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

EMA and HMA Publish Joint Network Strategy to 2028

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection. 

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

DCAT Week 2025: Quality and Compliance for Animal-derived Products

The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.

Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

Quality Systems