US Food and Drug Administration (USFDA) has concluded Remote Regulatory Assessment (RRA) at Zydus Lifesciences’ formulations manufacturing facility at Matoda in Gujarat. USFDA had conducted a Remote Regulatory Assessment for the Prior Approval Supplement (PAS) of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg and 80 mg. At the closure, there were no observations noted, and the site was recommended for approval.
Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.
