In this week’s news, Pfizer and Sanofi talk CDMOs, another sterile injectable CDMO expansion and more…
Pfizer and Sanofi want to work with fewer CDMOs
Pfizer and Sanofi say the desire to work with fewer CDMOs is a reflection of their changing portfolios.
The firms made the comments at CPhI Worldwide in Madrid this month during a panel discussion focused on CDMO sector dynamics.
Predictions of CDMO consolidation are nothing new – here is an example of the same sentiment shared at the same event in 2004. But Pfizer and Sanofi’s candour is worth noting.
Tim Kent, Pfizer VP of business development, global supply, told delegates his firm’s desire to move from working with 400 suppliers to around 10 reflected its changing business model.
“We have a changing profile” he said, “we move from making lots and lots of tablets to making very niche products. As we do that our portfolio of sites needs to change.”
This was echoed by Gerard Bellettre, director of strategic planning at Sanofi, who cited generic competition as a factor. “Suddenly, in the US in one year, you lose 70% of your volumes, then you’re left with empty sites.”
For CDMOs, the take home message is to keep a close eye on how your customers are responding to their markets.
Grand River Aseptic to build third injectable plant in Michigan
Grand River Aseptic Manufacturing will build a third facility in Grand Rapids, Michigan according to local authorities.
Plans for the $60m, 62,400 square foot plant were detailed by the Michigan Economic Development Corporation (MEDC) last week. It said the investment was partly prompted by growing demand for sterile injectable drugs.
MEDC also said GRAM’s existing manufacturing facilities in the city are operating at near capacity. The plant is scheduled to open in 2020 and is expected to create 100 jobs.
Coverage of the investment focused on the ongoing lack of aseptic manufacturing capacity industry wide. See FiercePharma’s story.
US FDA advises industry of product verification
The US FDA has issued draft guidelines to help drug manufacturers and wholesalers understand how to investigate suspect products.
The US regulatory published the document last week, explaining the aim is to let industry know the requirements of systems used to identify, examine and quarantine products they believe to be fake.
“Manufacturers must have systems in place that will allow them to respond to requests from trading partners to confirm that a particular product identifier, including the standardized numerical identifier, on the product that is the subject of the request corresponds to the product identifier that was affixed or imprinted on that product by the manufacturer of that product,” according to the draft.
It also sets out how suspect products should be separated from the rest of the supply chain and makes clear how manufacturers and their trading partners should notify the agency of any such products.
Pharma working hard to be compliant before DSCSA enforcement say experts
Logistics experts say most drug companies are accelerating preparations for enforcement of the US DSCSA which is due to begin next month.
Packaging News spoke with several serialization services providers to gauge how ready the drug industry is for the new rules and found that, while there are still concerns, the sector has made considerable progress.
Brian Daleiden, vice president of industry marketing at TraceLink, told the publication that, in contrast with previous years, he is positive most firms will be ready, explaining “The sense is that most of the market will be ready for the upcoming DSCSA deadline.”
However, he urged companies to look ahead to the next set of DSCSA requirements. “Since many companies have been laser-focused on becoming serialization ready by deadline, many have deferred preparing for the next phase of DSCSA, which is when pharmaceutical manufacturers need to have systems in place to meet the impending saleable returns verification requirements imposed on wholesale distributors.”
Read the full article here.
Also in the news
STAT reported the approval of a new type of flu treatment. The drug, called Xofluza, is approved for people who have had flu symptoms for 48 hours. It works my interrupting viral replication.
The New York Times looked at the impact of a potential alliance between US President Donald Trump and House Democrats on drug prices.