The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.

Jerrod Nichols Smith, one of three people indicted in 2013 for a drug wholesaling scam in Tennessee, was convicted last week of 15 counts of mail fraud and one…

Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.

The decision by Lonza to move cell-therapy work out of a U.S. facility that was hit by an FDA warning letter will cost the plant about 125 jobs.

Indonesia's Kalbe Farma has opened a $35 million plant near Jakarta to produce biologics for the local market.

Takeda, which recently announced a deal to buy stem cell therapy biotech TiGenix, will build a plant in Ireland to produce the treatment.

CDMO Almac, which has been bulking up its capacity and services, has opened a new cold storage facility at its Northern Ireland headquarters campus.

An Indian drugmaker has halted production of a couple of APIs after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu,…