Sodium Zirconium Cyclosilicate

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AstraZeneca has opened its expanded Coppell, TX, facility which makes its hyperkalemia drug Lokelma, the company said Wednesday. The $445 million expansion has doubled the production of Lokelma. Avidity Biosciences has delayed its biologics license application submission to the FDA for its Duchenne muscular dystrophy treatment called delpacibart zotadirsen, or del-zota for short. It will file in the first quarter of 2026 rather than the end of the year to add extra CMC data for its BLA, it said on Monday. A new CDMO called Codis has launched . The company comes from a merger of US Particle Dynamics and a UK spray drying facility formerly owned by EuroAPI. Codis will focus on commercial spray drying, amorphous solid dispersions and particle engineering tech. It will operate out of three sites in St. Louis, MO, Seymour, IN, and Haverhill, UK. LTS Lohmann Therapie-Systeme has acquired the US-based CDMO Renaissance Lakewood. The transaction is expected to close by the end of November. The Monday release did not give financial details. Nusano will supply radioisotopes, including actinium-225 and lutetium-177, to Ariceum Therapeutics under a new partnership. GC Biopharma has secured contract manufacturing rights for a recombinant shingles vaccine named amezosvatein from Curevo Vaccine. GC Biopharma will be responsible for making some of the commercial supply of the vaccine for global distribution. Amezosvatein is in a Phase 2 study expected to be completed by 2026. Coalition for Epidemic Preparedness Innovations (CEPI) is collaborating with Serum Institute of India to develop a vaccine to target H5N1 bird flu, which will be a prototype for pathogens with pandemic potential, the companies said Monday.

Analysis by GlobalData’s Pharma Intelligence Centre forecasts annual global sales of Lokelma to reach $938m by 2031. Mats Wiklund via Shutterstock.com. AstraZeneca has unveiled a newly expanded manufacturing facility in Texas to the tune of $445m, as the drugmaker aims to meet increasing demand for hyperkalaemia treatment Lokelma (sodium zirconium cyclosilicate). The near half a billion-dollar expansion at AstraZeneca’s manufacturing facility in Coppell, Texas, adds a new 9,000ft² building, which will house two production lines. The investment will also fund upgrades for drug substance and drug product laboratory testing, along with additional space for warehousing and administration. Overall, AstraZeneca says the expansion will double the production of Lokelma. Lokelma is an oral suspension treatment that lowers potassium levels in the blood. The drug was US Food and Drug Administration (FDA)-approved in 2018, three years after being acquired by AstraZeneca in a takeover of ZS Pharma for $2.7bn. Lokelma generated $542m in 2024, an increase of 32% from 2023. Analysis by GlobalData’s Pharma Intelligence Centre forecasts annual global sales to reach $938m by 2031. GlobalData is the parent company of Pharmaceutical Technology . AstraZeneca’s Texas facility, which employs more than 250 people, is the sole supplier of Lokelma to more than 50 countries, including the US. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Our manufacturing facility in Coppell serves as both a critical pillar in global healthcare and has played an important role in supporting the local workforce over the past 10 years. The expansion underscores our commitment to patients and support for Texas’ long-term vision for scientific growth and innovation,” said Jim Fox, AstraZeneca’s senior vice president of Americas Supply Operations. The $445m investment into Coppell comes a week after AstraZeneca commenced construction on its new $4.5bn active pharmaceutical ingredient (API) manufacturing facility in Virginia. The work in both Coppell and Virginia is part of a wider $50bn outlay by the company to bolster manufacturing capabilities in the US by 2030. Decreasing reliance on drugs manufactured overseas has been a key ambition of the Trump administration. In May, Trump signed an executive order that will streamline the path for pharma companies to build new US drug manufacturing production sites and improve inspection times for US facilities. The FDA then launched a scheme that would make it easier for new facilities to be approved in August 2025. AstraZeneca is one of many non-US big pharma companies to turn its attention to the US. Swiss big pharma Roche outlaid $50bn worth of investment in the US, which will generate more than 1,000 jobs in new and expanded facilities. British drugmaker GSK said it would invest $30bn in the US over the next five years. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now