News about Manufacturing

US FDA Places Sun Pharma's Baska Facility Under 'Official Action Indicated' After Inspection

Sun Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration (FDA) has assigned an “Official Action Indicated” (OAI) status to its Baska manufacturing facility following a recent regulatory inspection.

Manufacturing | 18/12/2025 | By Darshana

US FDA Issues EIR with VAI Classification to Lupin's Nagpur Injectables Plant

Global pharmaceutical major Lupin Limited (Lupin) has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable manufacturing facility located in Nagpur, India.

Manufacturing | 17/12/2025 | By Darshana

TempraMed Secures South Korea Patent for VIVI Box Medication Storage Technology

TempraMed Technologies Ltd, a medical-technology innovator transforming how temperature-sensitive medications are stored and managed, announced that it has been granted an additional allowed patent in South Korea, issued under Korean Patent Application No. 10-2021-7011422.

Manufacturing | 17/12/2025 | By Darshana

EU Approves AstraZeneca's Saphnelo for Subcutaneous Self-Administration in Lupus

AstraZeneca has received approval from the European Commission for subcutaneous self-administration of Saphnelo (anifrolumab) using a pre-filled pen for adult patients with systemic lupus erythematosus, in addition to standard therapy.

Manufacturing | 17/12/2025 | By Darshana

PharmAla Biotech Australia Ties Up with UK CDMO to Manufacture ALA-002

PharmAla Biotech Australia has contracted a UK-based CDMO to manufacture the drug substance for ALA-002, its patented non-racemic MDMA formulation, ahead of planned phase 2a/2b clinical trials for social anxiety disorder expected to begin in 2026.

Manufacturing | 16/12/2025 | By News Bureau

Novartis Breaks Ground on Flagship Manufacturing Hub in North Carolina

Novartis has officially begun construction of its flagship manufacturing hub in North Carolina, reinforcing its commitment to end-to-end production of key medicines for US patients. The project, highlighted by FDA Commissioner Marty Makary and Governor Josh Stein, underscores Novartis’ ongoing investment and growth in the US pharmaceutical sector.

Manufacturing | 15/12/2025 | By News Bureau

Lupin Manufacturing Solutions and PolyPeptide Form Strategic Alliance to Strengthen Global Peptide Supply Chains

Lupin Manufacturing Solutions (LMS), a subsidiary of Lupin, has entered into a long-term strategic partnership with PolyPeptide Group AG, a global contract development and manufacturing organisation specialising in peptide-based active pharmaceutical ingredients.

Manufacturing | 12/12/2025 | By Darshana |  121

Sovereign Pharma Commissions India's First High-Volume Isolator-Based Ampoule Manufacturing Line

Sovereign Pharma has commissioned its first isolator-based filling line as part of a long-term modernisation plan to upgrade three of its filling lines to advanced isolator systems. The newly commissioned line is fully operational and marks a major milestone in the company’s shift toward next-generation sterile manufacturing.

Manufacturing | 12/12/2025 | By Darshana

Eli Lilly Expands USA Manufacturing with Alabama Plant

The site will focus on producing synthetic and peptide-based medicines, including Lilly’s first oral GLP-1 weight-loss therapy, Orforglipron, which the company expects to submit for regulatory approval early next year.

Manufacturing | 11/12/2025 | By Darshana

AsymBio Begins Operations at Fengxian Base to Boost Global CDMO Capacity

AsymBio has commenced commercial operations at its 130,000-square-metre Fengxian base, adding a major hub to its global CDMO network alongside its Shanghai Jinshan and Zhangjiang facilities. The new site is built to offer flexible, scalable support across all clinical phases, delivering customised CDMO solutions.

Manufacturing | 08/12/2025 | By Dineshwori