A roundup of manufacturing news from Sanofi, Orano Med, and Endo. Highlights below 

* Sanofi Investing $42 M To Expand Bioproduction in France
* Orano Med Investing $262 M To Expand Radiopharmaceutical Mfg Capacity
* Endo Voluntarily Recalls Additional Lots of Anti-Seizure Drug for Labeling Issues

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Sanofi Investing $42 M To Expand Bioproduction in France 
Sanofi has announced an investment of EUR 40 million ($42 million) in its bioproduction site in Lyon (Gerland), France. 

As this investment, EUR 25 million($26 million) is dedicated to the production and development of Thymoglubulin, an anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits and used as an immunosuppressant and exclusively manufactured at Sanofi’s Lyon Gerland site. The site now produces 1.6 million vials to treat approximately 70,000 patients per year in 74 countries. Sanofi has developed a new manufacturing process to  increase production capacity. Modernization work began in the summer of 2024. The first industrial batches will be produced in 2025, and the first commercial batches available in 2027.  

Additionally, Sanofi is investing EUR 15 million ($15.7 million) to internalize and localize production in France of TZield (teplizumab-mzwv), a drug to treat Type 1 diabetes. Sanofi acquired the drug in April 2023 through its $2.9-billion acquisition of Provention Bio, a Red Bank, New Jersey-based bio/pharmaceutical company; the drug had been manufactured outside of Europe. The development of the bioproduction zone will begin in early 2025. The first batches will be produced by the end of 2025 and will be available for marketing from 2027. 

Overall, Sanofi has committed EUR 2.5 billion ($2.6 billion) in major projects since the COVID-19 pandemic, and more than EUR 1 billion ($1.05 billion) of additional investment in bioproduction announced last May (May 2024). Sanofi says that ensures 60% of its global production is within the European Union.  

Source: Sanofi (in French) 

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Orano Med Investing $262 M To Expands Radiopharmaceutical Mfg Capacity 
Orano Med, a developer and producer of radiopharmaceuticals, has broken ground for a EUR 250-million ($262 millon) facility in Bessines-sur-Gartempe in Haute-Vienne,  France,  for the production of thorium-228, a precursor of lead-212, used in radioligand therapies. The facility has over 7,000 m² of floor space and is scheduled for commissioning in 2027 and wil increase current production to support clinical and commercial-scale production. In 10 years, the company estimates that the industrial platform will enable the production of 100,000 doses of its lead-212 radiopharmaceuticals. 

Source: Orano Med 

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Endo Voluntarily Recalls Additional Lots of Anti-Seizure Drug for Labeling Issues 
Endo, a specialty pharma and generics company, is expanding its voluntary recall of clonazepam orally disintegrating tablets, USP (C-IV), due to potential product carton strength mislabeling. Specifically, Endo’s ongoing investigation has identified the possibility that an additional 16 clonazepam product lots contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. The product lots were distributed through wholesale distributors to retail pharmacies nationwide in the US.  

Clonazepam orally disintegrating tablets are indicated alone or as an adjunct in the treatment of Lennoz-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder. 

The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical, which previously marketed clonazepam before the product was acquired by Endo. 

Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory.  

Source: Endo