Mfg News: Sandoz, Novo Nordisk, Torrent & More 

A roundup of manufacturing news from Sandoz, Novo Nordisk, Alkermes, Torrent Pharma, and Full-Life Technologies. Highlights below. 

* Sandoz Begins Construction of $400-M Biosimilars Mfg Plant 
* Novo Nordisk To Buy Alkermes’ Mfg Facility for $92 M 
* FDA Cites Torrent Pharma Mfg Facility 
* Full-Life Technologies Breaks Grounds on New Radiopharmaceutical Mfg Facility 

Sandoz Begins Construction of $400-M Biosimilars Mfg Plant 
Lek, acquired by Novartis in November 2002 and now a Sandoz subsidiary, has begun the first stage of construction of a new $400-million production center for biosimilars in Lendava, Slovenia. 

The first of three facilities to be built on the site of Lek’s current location in Lendava will be used to generate energy products for existing production, as well as meet the needs of the future center for the production of drug substance for biosimilars. The center will also include facilities for production and storage. Their combined surface area will amount to 40,000 square meters. The center is expected to be operational by the end of 2026. 

Source: Lek (facility opening) and Lek (Novartis acquisition) 

Novo Nordisk To Buy Alkermes’ Mfg Facility for $92 M 
Novo Nordisk has agreed to acquire the development and manufacturing facility in Athlone, Ireland of Alkermes, a Dublin, Ireland-based bio/pharmaceutical company, for $92.5 million. The facility has approximately 400 employees involved with oral drug development and manufacturing.  

Under the agreement, upon the closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments. The transaction is expected to close in mid-2024, subject to certain closing conditions. 

Alkermes and Novo Nordisk also plan to enter into subcontracting arrangements to continue certain work currently performed at the facility for a period of time after closing of the transaction, which may continue through the end of 2025.  Alkermes will continue to retain all royalty revenues associated with products currently manufactured at the facility. Alkermes will continue to manufacture certain of its proprietary commercial products at its facility in Wilmington, Ohio.  

Source: Alkermes 

FDA Cites Torrent Pharma Mfg Facility 
The US Food and Drug Administration (FDA) has issued a Form 483 with five observations to Torrent Pharmaceuticals, an Ahmedabad, Gujarat, India-based bio/pharmaceutical company, for its oral oncology manufacturing facility in Bileshwarpura, Gujarat, India. 

The citation comes after the FDA conducted a pre-approval inspection of the facility from December 5 to December 11, 2023. At the end of the inspection, Torrent was issued a Form 483 with five procedural observations. The company says it will respond to the FDA within the prescribed timeframe and will work with the agency to address the observations at the earliest possible time. 

Source: Torrent Pharmaceuticals 

Full-Life Technologies Breaks Ground on New Radiopharmaceutical Mfg Facility  
Full-Life Technologies, a Gembloux, Belgium-based radiotherapeutics company, has broken ground for a new 4,000-square-meter GMP radiopharmaceutical manufacturing facility in Gembloux, Belgium. The facility will sit on 17,000 square meters of land.  

Source: Full-Life Technologies