Pharmaceutical Manufacturing

Pharmaceutical Manufacturing
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Sanofi, confident in the growth of its influenza vaccines, has committed to spending $202 million to build a new manufacturing facility at its Val-de-Reuil site in north-western France. The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to expand its supply of influenza vaccine, VaxigripTetra, to up to 70...

After receiving a Form-483 from the U.S. FDA earlier this year, Sun Pharma says its Dadra manufacturing facility has now been cleared by the regulator. During an inspection in April, the FDA found 11 quality lapses at the Dadra unit, which included incomplete laboratory records, failure to create accurate duplicates of key records, failure to...

Few industries have as much to gain from data-driven decision making as pharmaceutical manufacturing. The disruptive forces impacting the industry — rising cost pressure, greater use of contract manufacturing, the introduction of personalized medicine, increasing packaging complexity, unrelenting quality control demands — cry out for the insights...

Reuters reports that Novartis decided not to sell its roughly $14 billion, 33 percent voting stake in Roche, according to Chairman Joerg Reinhardt in an interview in Swiss newspaper HandelsZeitung. “We said we would review whether it makes sense to sell the stake,” Reinhardt said. “We came to the conclusion that that’s not the case. We have made no...

It’s not too late for the pharmaceutical industry to dodge its reputation for being woefully behind other industries in terms of adopting technology. Pharma, facing somewhat of a “digital crossroads,” is still poised to capitalize on the vast benefits of digital transformation. Digital transformation is best defined as the adoption of new...

For quite some time, the highest compliment that could be paid to a hitter or pitcher in baseball has been to say, “he/she hits/throws like a machine.” We refer to something being performed with precision, over and over, as “machine-like.” So it stands to reason that, if we automate any system (correctly), it will perform better than a manual...

The process of converting biological agents into pharmaceuticals is one of the most sophisticated and stringent manufacturing processes. Consider: an aspirin molecule contains 21 atoms. A biopharmaceutical molecule could consist of anywhere from 2,000 to 25,000 atoms. Consistently reproducing these complex compounds from their origin in a...

On Tuesday, French police searched a Merck plant in Lyon in order to follow up on patient complaints about changes to its thyroid drug Levothyrox. Merck has pledged to help investigators in their search. The search was carried out by a unit of the national police responsible for public health. Approximately 3 million French people use Levothyrox, a...

As you may recall, President Trump issued two executive orders earlier this year to investigate what can be updated to improve efficiency and reduce costs in the FDA as a whole. No matter which side of the political fence you’re on, you now have a chance to help the FDA implement these orders in a way that stays true to the Agency’s public health...

Pharmaceutical Manufacturing

 •  September 24

Aegerion Pharmaceuticals Inc. will plead guilty in the U.S. District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce, according to a FDA press release. In connection with this...