According to reports from CNBC TV18, Onesource Specialty Pharma announced that its partner Orbicular Pharmaceutical has received a tentative approval from the US Food and Drug Administration (USFDA) for the generic version of Ozempic. The approval covers the abbreviated new drug application (ANDA) for the generic version of the weight loss drug, marking a significant regulatory milestone for the collaboration. As per CNBC TV18, Orbicular Pharma with its US-based front-end partner have secured the USFDA approval for the generic Ozempic.
As reported by CNBC TV18, Onesource serves as the contract development and manufacturing organization (CDMO) partner for the product, while Orbicular led the product development and technical program for the complex peptide. Onesource supported the program as the CDMO partner, providing end-to-end manufacturing capabilities for the US market filing. The collaboration is designed to ensure reliable commercial supply from Onesource's USFDA approved flagship site in Bengaluru, as confirmed by the company's filing.
According to CNBC TV18, Neeraj Sharma, CEO and MD of Onesource Specialty Pharma Ltd., stated that this milestone reflects Orbicular's scientific expertise and Onesource's CDMO capabilities, supported by their USFDA-approved manufacturing site. The collaboration represents a successful integration of development expertise with manufacturing capabilities for the complex peptide drug.
As reported by CNBC TV18, Onesource Specialty Pharma shares were down 1.1% at ₹1,532.7 apiece at 9:22 am on Tuesday, April 21. The stock has gained 10.3% in the past month but has declined 14.3% this year so far. The market reaction suggests investors may be taking a cautious approach despite the positive regulatory development, with analysts recommending these stocks to keep on radar in today's trade.
