A roundup of manufacturing news from Vivint Pharma, Baxter & B. Braun Medical. Highlights below. 

* Vivint Pharma Investing $48 M To Build New Injectables Mfg Facility in India 
* Baxter Voluntarily Recalls One Lot of Heparin for Elevated Endotoxin Levels 
* B. Braun Voluntarily Recalls Two Lots of NaCl Injectable for Particulate Matter, Fluid Leakage   

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Vivint Pharma Investing $48 M To Build New Injectables Mfg Facility in India 
Vivint Pharma, a Hyderabad, India-based pharmaceutical company of injectables, has announced its plans to establish an injectables manufacturing facility in Genome Valley, Hyderabad, India.  

The company will be investing ₹400 crores ($48 million) in the new facility with the potential to employ 1,000 people. The facility will focus on the development and production of injectable drugs in the oncology and critical care space for both domestic and international markets. 

The company has an R&D center in Genome Valley and has invested about ₹70 crores ($8 million) in the facility. To consolidate its strengths and foray into international markets, the company has decided to establish its first manufacturing plant and has acquired 5.5 acres in Genome Valley to do so. 

Source: Vivint Pharma 

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Baxter Voluntarily Recalls One Lot of Heparin for Elevated Endotoxin Levels 
Baxter International, a medical technology and healthcare company, is voluntarily recalling one lot of heparin sodium in 0.9% sodium chloride injection to the consumer level in the US due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to the lot being recalled.  

The drug is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 mL in Viaflex Plus Plastic Container-1 unit per pouch. This issue affects one lot of product that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers, and distributors in the US.  

Source: US Food and Drug Administration 

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B. Braun Voluntarily Recalls Two Lots of NaCl Injectable for Particulate Matter, Fluid Leakage 
B. Braun Medical, a Melsungen, Germany-headquartered medical technology company of IV fluids and related products, is voluntarily recalling two lots of 0.9% sodium chloride (NaCl) for injection, USP 1,000 mL in E3 containers within the US to the consumer level due to the potential for particulate matter and fluid leakage of the respective containers. 

The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter that may result in leakage. 

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.  

Source: US Food and Drug Administration