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FDA approves new formulation based on bioequivalency with existing product

Eurand Scores With Orally-Disintegrating Form Of GSK's Lamictal

Carrier tapes deliver precise dosages that can be pure API; canister technology improves pressurized dose delivery

3M Drug Delivery Expands Inhaler Options

Container maintains an effervescent analgesic while providing patient convenience

Sud-Chemie Package Wins Pharma Pack Award for Bristol-Myers Squibb

Catalent celebrates anniversary of its pioneering technology for oral solids

75 Years of SoftGel Capsules

Winners will be honored at May Annual Symposium

HCPC 2008 Compliance Packaging Winners Announced

PDA meeting showcases widening range of resources

More Tools for Handling Temperature-Controlled Shipping

New group of injectables manufacturers tussles with USP over use of labeling ‘real estate’ on vial caps

Out With Pedigree; In With Patient Safety

Two prefilled-syringe projects emphasize user friendliness

Syringe Design Gets a Makeover

Optimized dimensionality is the goal of new products from MTS and Cold Chain Technologies

Refinements in Cold Chain Secondary Packaging

Contract packagers are multiplying their product offerings to meet marketing and patient-safety concerns

The Packaging Contribution to Patient Adherence

Colorcon Opens West Coast Technology Center

Functional (“peel-off”) labels, common in Europe for injectables, represent a significant packaging improvement for safer and more efficient drug administration

Functional labels enhance patient safety and boost market access

The CDMO's California facility welcomes new production suites, a revamp of its development labs, and more. 

Fujifilm Completes Cell Therapy Plant Expansion Project

The CDMO is investing $3.6 million toward boosting its advanced labeling, automated visual inspection, and fill-finish tech.

Pii Invests in Prefilled Syringe Capabilities 

One packaging aspect—the tape—is often overlooked, but is a valuable component of the shipping process. 

Why Pharmaceutical Products Need Sustainable Packaging

With the design of the new 360,000 square-foot building, the CDMO’s goal is to continue to modernize its Laupheim site.

Rentschler Biopharma to Construct New Buffer Media Facility in Germany

With the implementation of unit-level traceability, the collaboration is expected to provide additional visibility not only within the aseptic manufacturing process, but the entire supply chain overall.  

BD, ten23 health to Roll Out Prefillable Syringes with RFID Capabilities

Analyzing Branded and Generic Pharmaceuticals

managing director, global operations & supply chain practice at UST, discussed how the East and Gulf Coast port strikes highlighted the contrasting dynamics between branded and generic pharmaceuticals. Branded drugs, which offer higher profit margins, are produced at limited manufacturing sites, creating potential vulnerabilities. In contrast, generics have multiple supply sources but operate with tighter margins, leading to less robust business controls and raising concerns about safety. This disparity underscores the complex challenges faced by both sectors in the pharmaceutical industry. Colehower also spoke on the valuable in pharma supply chain transparency and visibility.

A transcript of Colehower’s conversation with

How did the East and Gulf Coast port strikes bring to light the differences between branded and generic pharmaceuticals?

I think it’s a fascinating space because of the differences, and when I say the differences, there are a couple things that I'm talking about. One is just the difference between brand and generic pharmaceuticals. It's feast or famine. The brands have lots of margin that they can throw at the problem, but at the same time, they're so proprietary, it's restricted, so you may only have one manufacturing operation that's producing that brand. That's a point of failure that has to be managed.

On the other hand, there’re the generics, where you may have lots of sources of supply, but they don't have the margin. Because they don't have the margin, they don't have some of the same business controls that in other cases might be a luxury, so you then start worrying about things like safety.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, describes how events such as the East and Gulf Coast port strikes have brought to light the differences between branded and generic pharmaceuticals. 

Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, speaks on key takeaways from his "Fight for the Dollar" keynote speech. 

Access Insights 2023: Bill Roth Provides an Overview of his Keynote Speech, Fight for the Dollar

: The keynote was a culmination of a story that I've been working on all year long. We've always heard about the flow of the dollar. I'm getting quite tired of that one graphic that represents how brands flow. There's nine other flows. What became obvious to us over the last year and a half was this concept of the fight for the dollar. No one is really laying back and allowing the channels to basically use the manufacturers. Between 340B, the removal of the AmCap, and the addition of the IRA, price increases as we know it have been abolished. If you do it moving forward, you're going to wind up regretting the actions. The way that I open it up, I ask this question: If you put a dollar bill equidistant in a four way intersection and you put a payer pharmacy/distributor equal to that and a gun goes off, who gets to the dollar bill first and why? Traditionally, the answer has been not the manufacturer. The fight for who gets that money has created awkwardness and I think the ability to talk about that in front of a group like this is great because we're putting a problem on the table that we all need to solve. 

SVP and Managing Director for Blue Fin Group offers a synopsis of the conference opener. 

Latest Conference Coverage

 editor Nicholas Saraceno, Andrew Brownlee, director, Berkeley Research Group, discusses how manufacturers calculate 340B pricing. 

Access Insights 2023: Andrew Brownlee Discusses How Manufacturers Calculate 340B Prices

: It is subject to a formula that all manufacturers have to provide. For branded pharmaceuticals, it is a ceiling price, which means that it's the maximum price that a manufacturer can charge for a 340B priced product. That ceiling price is subject to a discount of the unit rebate amount (URA). The URA is the greater of 23.1%, or the best price, which is essentially the greatest discount that the manufacturer offers on the branded product. Each 340B discount is also subject to an inflationary penalty, so if the list price of the product grows faster than core inflation, then there would be an additional discount added to the URA. 

Berkeley Research Group executive speaks about the role of manufacturers in 340B pricing. 

Manufacturing & Packaging

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