USFDA completes inspection at Aurolife Pharma’s Raleigh unit
The unit has filed 2 Derma products and 1 MDI product.
The unit has filed 2 Derma products and 1 MDI product.
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
With this, the company can start selling Ibuprofen in the European markets.
The expansion at CDMO facility in South Haven, will bring a new 4,000-gallon multi-use reactor train consisting of glass lined and stainless-steel materials of construction
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
Company is investing more than €100 million in the expansion of the Halle site
Meets the growing need for US-based API solubility and bioavailability enhancement services
Addition of Pepscan with its peptide discovery, lead optimization and GMP manufacturing capabilities provides end-to-end offering to Biosynth Carbosynth’s peptide customers.
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