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Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the

Amarox, the U.K. unit of India’s Hetero Group, issued a voluntary recall of one batch of sertraline tablets in Britain after a patient found two different antidepressants packaged together.

Novartis will construct an active pharmaceutical ingredient (API) facility in Morrisville, North Carolina, the company said Thursday. The 56,200 square-foot plant will manufacture compounds for solid-dose tablets, capsules and RNA therapeutics.

After recalibrating its production strategy in the late 2010s to help meet the realities of the CAR-T market, Gilead Sciences’ Kite Pharma is preparing to hit the ground running with the potential

During Pfizer’s right-sizing push after the COVID-19 pandemic, the company’s multibillion-dollar cost-cutting campaign has affected its Ireland operations in several ways. Now, more employees in the country are set to lose their

Evonik plans to spend €80 million ($93.5 million) to upgrade its bio fermentation production technology in Slovenská Ľupča, Slovakia, as part of an expansion that will add 50 new jobs.

Like with many other pharma giants, AbbVie’s manufacturing expansion will see the company put down roots in North Carolina.

As Samsung Biologics presented a massive quarterly revenue growth, 2,200 people rallied ahead of a planned labor union strike.

Biovac has secured a $108.3 million financing package that will allow the South African pharma company to build the continent’s first end-to-end, multi-vaccine production plant.