Manufacturing Solutions, a subsidiary of Lupin, has signed a long-term strategic alliance with PolyPeptide Group AG to scale the supply chain of peptide-based active pharmaceutical ingredients. PolyPeptide Group AG is a specialised Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients.
has informed the exchanges that it has received a Form 483 from the United States Food & Drug Administration (US FDA) following an inspection conducted at its formulations manufacturing facility at Srikakulam, Andhra Pradesh. The inspection, which took place from December 4 to December 12, 2025, encompassed a dual review: a Good Manufacturing Practices (GMP) assessment and a Pre-Approval Inspection (PAI). During the process, the US FDA identified and issued five specific observations related to the facility’s operations. The company said that it’s committed to addressing the observations raised by the US FDA.
An active pharmaceutical ingredient (API) manufacturing facility of subsidiary Apitoria Pharma in Hyderabad has received three observations from the U.S. Food and Drug Administration. The U.S. FDA inspected Unit-V, an API manufacturing facility of subsidiary Apitoria Pharma in Pashamylaram village, Sangareddy district, from December 1-12. At the end of the inspection, a Form 483 was issued with three observations. Aurobindo Pharma said the observations are procedural in nature and the company will respond to the U.S. FDA within the stipulated timelines.
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of , has announced a new settlement and license agreement with Regeneron and Bayer for biosimilar Aflibercept (40mg/ml) in Europe and the rest of the world, which follows an earlier settlement covering the United States and Canada. This agreement clears the way for Biocon Biologics to commercialize Yesafili®, a biosimilar Aflibercept (40mg/ml), in all countries worldwide.