Stelis Biopharma’s flagship facility receives EIR from USFDA
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Company is investing more than €100 million in the expansion of the Halle site
Facility features LED lighting, solar panels, automation and innovative temperature-controlled systems to maximize efficiency and minimize environmental impact
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
The scope of supply includes the skid-mounted plant as well as on-site installation and commissioning support
The expansion makes Exothera one of the largest viral vector facilities in Europe
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