Mfg News: Takeda, Hikma, Orano Med, WHO & More 

A roundup of manufacturing news from, Takeda, Hikma Pharmaceuticals, Orano Med, Glenmark Pharmaceuticals and the World Health Organization. Highlights below. 

* Takeda Breaks Ground on $230-M Plasma Fractionation Expansion 
* Hikma To Acquire Select Mfg & Product Assets from Xelia 
* Orano Med Opens New Radiopharmaceutical Mfg Facility 
* Glenmark Voluntarily Recalls Select Lots of Potassium Chloride Extended-Release Capsules
* WHO Issues Warning for Falsified Diabetes & Weight Loss Drugs

Takeda Breaks Ground on $230-M Plasma Fractionation Expansion 
Takeda has announced a $230-million expansion of manufacturing capacity for plasma-derived therapies at its plasma-fractionation facility in Los Angeles, California. This represents one of Takeda’s largest single investments in manufacturing capacity expansion at its Los Angeles site ,which is Takeda’s largest fractionation site in terms of capacity globally.  

Source: Takeda 

Hikma To Acquire Select Mfg & Product Assets from Xelia 
Hikma Pharmaceuticals, a London-based bio/pharmaceutical company, has agreed to acquire parts of the US finished dosage-form business and assets of Xellia Pharmaceuticals, a Copenhagen, Denmark-based bio/pharmaceutical company. The sale includes a commercial portfolio and pipeline of differentiated products, a manufacturing facility in Cleveland, Ohio, sales and marketing capabilities, and separately an R&D center in Zagreb, Croatia. Hikma will pay a cash consideration of $135 million, and an additional contingent consideration of up to $50 million, subject to the achievement of certain regulatory and commercial milestones. 

The acquisition will add eight approved and marketed injectable products to Hikma’s US portfolio and 11 pipeline products. The Xellia commercial portfolio comprises ready-to-use products, including Vanco Ready (vancomycin), launched in 2019, and other anti-infectives. These products are currently manufactured by a third-party, and Hikma will maintain these manufacturing contracts while it upgrades the Cleveland facility, with the goal of moving production of these products in-house. 

The Cleveland site offers end-to-end capabilities to develop, manufacture, pack and distribute lyophilized vials and aseptically filled ready-to-use IV bag products. Hikma intends to undertake a series of investments to enhance productivity and efficiency through the addition of automation, equipment, and updated processes. These investments will be captured within Hikma’s existing annual capital expenditure plan. Hikma expects the facility to be operational within two to three years. 

The transaction is subject to US Federal Trade Commission approval. 

Source: Hikma Pharmaceuticals 

Orano Med Opens New Radiopharmaceutical Mfg Facility 
Orano Med, a developer and producer of radiopharmaceuticals, has opened an ATLab (Alpha Therapy Laboratory) in Brownsburg, Indiana, near Indianapolis, for the industrial-scale production of lead-212-based radioligand therapies.  

ATLab Indianapolis, with over 30,000 square feet of floor space, represents an investment of $20 million and will create 25 direct jobs. It will focus on the production of lead-212 therapies developed by Orano Med and their distribution in North America. In 2023, Orano Med started construction work on a similar facility in Valenciennes, France, to serve the European market.  

Combined, this will enable Orano Med to manufacture 10,000 doses a year worldwide as of 2025, with the aim of producing 10 times that number by the end of the decade. 

Source: Orano Med 

Glenmark Voluntarily Recalls Select Lots of Potassium Chloride Extended-Release Capsules 
Glenmark Pharmaceuticals, a Mumbai, India-based bio/pharmaceutical company, is voluntarily recalling 114 batches of potassium chloride extended-release capsules, USP (750 mg) 10 mEq K, to the consumer level in the US due to failed dissolution.    

The products being recalled were distributed nationwide to wholesale, distributor, and retail outlets. The expiration dates of the recalled batches are from June 2024 to September 2025. 

The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that may lead to cardiac arrest. 

Source: Glenmark Pharmaceuticals 

WHO Issues Warning for Falsified Diabetes & Weight Loss Drugs 
The World Health Organization (WHO) has issued a medical product alert on falsified semaglutides, the active ingredient in Novo Nordisk’s Ozempic/Wegovy/Rybelsus for treating Type 2 diabetes and obesity.  

The alert addresses three falsified batches of products of semaglutide, which were detected in Brazil and the UK in October 2023 and the US in December 2023. The WHO Global Surveillance and Monitoring System (GSMS) has been observing increased reports on falsified semaglutide products in all geographical regions since 2022. This is the first official notice issued by WHO after confirmation of some of the reports. GSMS works with WHO member states to improve the quantity, quality and analysis of accurate data concerning substandard and falsified medical products, and uses that data in the better prevention, detection and response to protect public health.  

Source: World Health Organization