Shilpa Biologicals commissions Antibody-Drug Conjugate (ADC) GMP manufacturing facility

Shilpa Biologicals, a material subsidiary of Shilpa Medicare, announced the commissioning of a state-of-the-art AntibodyDrug Conjugate (ADC) GMP manufacturing facility, purpose-built and designed to ...

WuXi Biologics' 25th Drug Substance Facility Completes First GMP Production, Manufacturing Process Execution with Zero Deviations

WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG17 drug substance facility located at the Shanghai Fengxian site ...
RAPS

FDA warns Intas, Centaur and Baxter over GMP violations at Indian facilities

The US Food and Drug Administration (FDA) on 1 August posted warning letters it recently delivered to three drugmakers, Intas Pharmaceuticals Limited, Centaur Pharmaceuticals Private Limited and ...
RAPS

FDA Redrafts GMP Policies for Outsourcing Facilities

The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to ...
The American Journal of Managed Care

FDA Issues Complete Response Letter for Cytisinicline NDA, Citing Manufacturing Deficiencies

Manufacturing-related cGMP observations at a former contractor, not cytisinicline-specific quality failures, and incomplete labeling formed the basis of the CRL rather than clinical concerns. Achieve ...
Nasdaq

Frontage CDMO Fully Operational GMP Facility is Ready for Your Needs of Clinical Trials and Commercial Production

EXTON, Pa., Jan. 15, 2026 /PRNewswire/ -- Frontage Laboratories, Inc., a leading contract development and manufacturing organization (CDMO) announced that its new facility opened in May 2025 had ...
BioProcess International

Shilpa Biologicals brings ADC manufacturing capacity to Dharwad, India

Shilpa Biologicals commissions ADC GMP plant in India, offering end-to-end drug substance manufacturing to meet FDA and EMA ...
MarketWatch

CyanoCapture and Persist AI Announce Strategic Collaboration to Build World's First Robotic GMP Facility for Oral Protein and Peptide Drugs

SAN FRANCISCO, Feb. 18, 2026 /PRNewswire/ -- CyanoCapture, the innovator in cyanobacteriabased oral drug delivery, and Persist AI, the leader in AI-driven robotic pharmaceutical formulation, today ...
Pharmabiz

Shilpa Biologicals commissions ADC drug substance GMP manufacturing facility

Shilpa Biologicals commissions ADC drug substance GMP manufacturing facility: Our Bureau, Mumbai Thursday, June 25, 2026, 17:35 Hrs [IST] Shilpa Biologicals Ltd, a subsidiary of S ...