Blog: Domestic Pharma Manufacturers Look to Expand
Blog: Domestic Pharma Manufacturers Look to Expand
Increased pressure on foreign producers means domestic pharmaceutical manufacturers now have a green light to expand their U.S. operations. But not everyone foresees a problem-free future.
With a goal to reduce the reliance the United States has on foreign producers and strengthen its domestic drug supply chains, last month the White House released an executive order directing broad regulatory changes. To transform pharmaceutical manufacturing, the order calls for expedited construction and expansion of existing facilities in the U.S.
Streamlining regulatory hurdles for domestic manufacturers while making it tougher for foreign producers to compete takes the form of the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Army Corps of Engineers simplifying their processes for permitting and oversight for those who make products in the U.S. while at the same time increasing fees and inspections for foreign manufacturers.
However, not everyone in the industry is optimistic about how effective the policy can be. Pharmaceutical Technology quoted Kathryn Kinch, senior pharma Product Manager at GlobalData as saying, “Critics are raising eyebrows over the lack of clarity surrounding its implementation.”
Despite the hurdles, the reshoring of critical supply chains that Americans rely on does have some strong supporters. According to The Hill’s opinion contributor George Laws Garcia, Puerto Rico is “one U.S. jurisdiction that is ready and in a perfect position to partner in this effort.” Called the “Medicine Cabinet of the U.S.,” he makes the point that Puerto Rico already accounts for more than $50 billion in annual pharmaceutical exports.
The climate will certainly give those players already in the U.S. reasons to expand. At the end of last month, Pennsylvania’s West Pharmaceutical Services announced “new roles to support increased drug delivery needs of chronic disease treatments such as diabetes and obesity as part of a recent contract manufacturing capacity expansion at its site in Williamsport.”
Large players such as Sanofi have announced plans to invest about $20 billion through 2030 to expand pharmaceutical manufacturing operations in the U.S. Added to the mix are new players, like Publix Super Markets, that intends to enter the market with a new $145 million pharmaceutical processing and manufacturing facility in Florida where workers assemble made-to-order prescription packages that are dispensed at Publix pharmacies after raw materials are unpacked and processed into salable form.
Most experts in the industry have come to understand that they must embrace new technologies if they are going to take advantage of this administration’s optimism. In fact, a new study by AspenTech has found digital transformation is on the rise among pharmaceutical manufacturers. Large producers, such as Pfizer, Johnson & Johnson, and Novartis are driving digital transformation to enhance production efficiency and maintain compliance.
And as manufacturers strive to speed up processes, spot problems in the system early, and even develop products quicker, generative artificial intelligence (GenAI) will play a larger role in operations. GenAI is already helping pharmaceutical teams in very specific tasks such as demand forecasting, inventory tracking, and reporting. Moreover, the promise includes customized solutions and new ones as well such as fully automated batch release, live quality control, and predictive simulations for production.
Cathy Cecere is membership content program manager.
Streamlining regulatory hurdles for domestic manufacturers while making it tougher for foreign producers to compete takes the form of the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Army Corps of Engineers simplifying their processes for permitting and oversight for those who make products in the U.S. while at the same time increasing fees and inspections for foreign manufacturers.
However, not everyone in the industry is optimistic about how effective the policy can be. Pharmaceutical Technology quoted Kathryn Kinch, senior pharma Product Manager at GlobalData as saying, “Critics are raising eyebrows over the lack of clarity surrounding its implementation.”
Despite the hurdles, the reshoring of critical supply chains that Americans rely on does have some strong supporters. According to The Hill’s opinion contributor George Laws Garcia, Puerto Rico is “one U.S. jurisdiction that is ready and in a perfect position to partner in this effort.” Called the “Medicine Cabinet of the U.S.,” he makes the point that Puerto Rico already accounts for more than $50 billion in annual pharmaceutical exports.
The climate will certainly give those players already in the U.S. reasons to expand. At the end of last month, Pennsylvania’s West Pharmaceutical Services announced “new roles to support increased drug delivery needs of chronic disease treatments such as diabetes and obesity as part of a recent contract manufacturing capacity expansion at its site in Williamsport.”
Large players such as Sanofi have announced plans to invest about $20 billion through 2030 to expand pharmaceutical manufacturing operations in the U.S. Added to the mix are new players, like Publix Super Markets, that intends to enter the market with a new $145 million pharmaceutical processing and manufacturing facility in Florida where workers assemble made-to-order prescription packages that are dispensed at Publix pharmacies after raw materials are unpacked and processed into salable form.
Most experts in the industry have come to understand that they must embrace new technologies if they are going to take advantage of this administration’s optimism. In fact, a new study by AspenTech has found digital transformation is on the rise among pharmaceutical manufacturers. Large producers, such as Pfizer, Johnson & Johnson, and Novartis are driving digital transformation to enhance production efficiency and maintain compliance.
And as manufacturers strive to speed up processes, spot problems in the system early, and even develop products quicker, generative artificial intelligence (GenAI) will play a larger role in operations. GenAI is already helping pharmaceutical teams in very specific tasks such as demand forecasting, inventory tracking, and reporting. Moreover, the promise includes customized solutions and new ones as well such as fully automated batch release, live quality control, and predictive simulations for production.
Cathy Cecere is membership content program manager.
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