Pharma Manufacturing News

Management at the factory level feel the heat under any FDA consent decree, but a shake-up at Johnson & Johnson ($JNJ) this week showed that the pressure can extend into the executive suite. Two Read more...

Workers at a Pfizer ($PFE) plant in upstate New York that makes birth control pills are learning that if you mispackage pills, it can create unwanted problems. Pfizer announced Wednesday that it is Read more...

A South Carolina plant Roche ($RHHBY) had on the auction block last year has developed manufacturing issues that have interrupted production of its weight control drug Xenical. Health officials in Read more...

Medical device manufacturers are doubling down on the FDA, agreeing to pay $595 million in fees over 5 years in exchange for promises of more and faster approvals and better communication from the Read more...

In many countries, asking for more regulation of the pharmaceutical industry would seem like asking for trouble. But not in Pakistan, where a drug manufacturing scandal involving the deaths of more Read more...

In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ($AMLN) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where the Read more...

The Novartis ($NVS) Nebraska plant closed in December because a host of over-the-counter products contained stray pieces from other drugs is expected to reopen this summer. Twice in recent days Read more...

Teva Pharmaceutical Industries' ($TEVA) Cephalon has recalled one lot of leukemia drug Treanda after glass fragments were found in one of the vials. FDA-approved labeling for Treanda states that the Read more...

Pfizer ($PFE) employees at the company's manufacturing hub in Puerto Rico are not happy with what company shenanigans did to Pfizer's stock price and to their retirement plans. They allege in a class Read more...

A fill/finish manufacturing agreement is part of the settlement between The Medicines Co. ($MDCO) and APP Pharmaceuticals ($APPX) over generic versions of The Medicines Co.'s lead product, Angiomax. Read more...

Ranbaxy Laboratories has been given a blueprint for removing regulatory constraints it incurred when it was discovered that some of its plants had severe manufacturing and data integrity issues. Now Read more...

Johnson & Johnson ($JNJ) will continue to ramp up its supply of over-the-counter drugs this year but it will be another year before its key manufacturing facility in Fort Washington, PA, will Read more...

Pressure from Asian low-cost chemical and drug ingredient suppliers, combined with high Swiss energy costs impacting manufacturing operations, have yielded poor financial performance at Lonza and the Read more...

Plans for the $500 million that Daiichi Sankyo set aside to get problem child Ranbaxy out of regulatory jail became clearer Wednesday with the filing of a consent decree. The Indian-based drugmaker Read more...

Analytics issues appear in the majority of FDA warning letter citations for manufacturing, including unvalidated methods and inadequate procedures for responding to out-of-spec test results. The Read more...