Morningstar

Nippon Shokubai Plans to Expand Its GMP-compliant Nucleic Acid Drug API Manufacturing Capacity Tenfold

Nucleic acid drugs are generally defined as "chemically synthesized drugs with oligonucleotides as active ingredients that exert their effects without being translated into proteins." (*2) As a new ...
Medical Dialogues

USFDA Raises Compliance Concerns at Hetero Labs' Nakkapalli Facility

Nakkapalli: Drug maker Hetero Labs has received a Form 483 issued by the United States Food and Drug Administration (USFDA) ...
Fox 5 San Diego

Made Scientific Powers Late-Phase and Commercial Cell Therapy Manufacturing with 12,000 sq. ft. Expansion in Princeton, NJ GMP Facility

Expansion Adds U.S. FDA and EU Annex 1 Compliant GMP Capacity with High-Throughput Manufacturing Design and Advanced Automation by Q3 2026. "As more therapies advance to late-stage development, the ...
CNBCTV18

Zydus Lifesciences arm’s pediatric Menkes disease drug CUTX-101 flagged by USFDA in CRL

Zydus noted that it had recently submitted responses to the USFDA following a re-inspection in September 2025, proving the facility’s CGMP compliance, and is currently awaiting the Establishment ...