Susan Haigney

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The European Medicines Agency (EMA) announced on Jan. 29, 2025 that the European Shortages Monitoring Platform (ESMP) now has full functionality (1). ESMP was created so that marketing authorization holders (MAHs) and national competent authorities (NCAs) can directly report information about the supply, demand, and availability of authorized medicines, especially during crises situations. The information can then be used by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). EMA launched the platform in November 2024 (2) with core functionalities available at the time. On Feb. 2, 2025, use of ESMP becomes mandatory for MAHs and NCAs.

ESMP features monitoring and management of critical medicines during public health emergencies and is a requirement of EMA’s mandate to enhance monitoring of drug shortages and prepare for critical situations in the European Union and the European Economic Area (EU/EEA). The platform features harmonized reporting standards to enhance usability of data to allow the EU/EEA to quickly coordinate actions to mitigate drug shortages.

Training on the platform is available through webinars and information provided on EMA’s website. EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party provides additional information in its webpage (3). Information about drug shortages in the EU is available 

on EMA’s shortages catalogue and national shortages catalogues

“The release of the ESMP is a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most,” the agency stated in the November 2024 press release (2). “It will centralize and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the [EU and EEA].”

The industry often experiences drug shortages due to quality control issues, natural disasters, and periods of high demand. According to FDA in the United States, the leading causes of shortages are manufacturing quality issues, followed by delays in receiving materials from suppliers (5). Drug companies in the US have been required since 2012 to notify FDA about changes in product production of certain medicines to prevent shortages. And in 2024, FDA’s ability to identify and mitigate such shortages was enhanced by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which says that manufacturers must notify the agency of a permanent discontinuation of these crucial products, interruption of manufacture of these products, permanent discontinue of an API used in these products, and interruption of APIs used in these products (5).

EMA. European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU. Press Release. Jan. 29, 2025.

EMA. European Shortages Monitoring Platform Enables Better Monitoring of Shortages in the EU. Press Release. Nov. 28, 2024.

EMA. Medicine Shortages Single Point of Contact (SPOC) Working Party. 

https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party

EMA. Public Information on Medicine Shortages. 

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/public-information-medicine-shortages

FDA. Frequently Asked Questions about Drug Shortages. 

, Dec. 18, 2024 (accessed Jan. 29, 2025). 

https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages

Articles

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

European Drug Shortage Monitoring Platform Fully Operational

Sustainability in Pharmaceutical Outsourcing

The pharmaceutical industry has a significant impact on the environment that includes CO

 emissions, water consumption, use of plastics, and a variety of manufacturing practices (1). Therefore, sustainability and green manufacturing are becoming priorities for the pharmaceutical industry due to evolving and changing regulations to protect both the environment and patients. 

spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers as they work with sponsors on the development and manufacture of drugs and biologics in a sustainable fashion that aligns with industry and regulatory requirements.

“Sponsors are increasingly requiring sustainable or green manufacturing practices when negotiating for partnerships with Neuland,” says Davuluri. “I think this trend is also kind of aligned with the broader industry shift towards sustainability … we are seeing that a lot of these companies are having their own approach on or their own frameworks in what they would like to measure their partners with. This is not just about Europe versus US, but also within a particular geography, every company has a different approach. Earlier, we used to see only big pharma or large generic companies having particular requirements. But now we're even seeing a lot of small to mid-sized biotechs talking to us and measuring us on our sustainability related practices as well.”

Click the video above to watch the interview.

1. Di Russo, M.; Zjalic, D.; Lombardi, G.S.; Perilli, A.; Congedo, G.; Daugbjerg, S.; Cadeddu, C. Impact of the 50 Biggest Pharma Companies: A Review of Environmental Report Aspiring to NetZero. 

https://doi.org/10.1093/eurpub/ckad160.1182

Saharsh Davuluri is Vice-Chairman and Managing Director, Neuland Laboratories. Saharsh is an electrical engineering graduate and obtained his master’s in management information systems from Weatherhead School of Management, Cleveland, Ohio, USA. He also secured Master of Business Administration from University of North Carolina, USA. He has worked in the past with Sify Limited in various roles in the Sales organization. He joined Neuland in 2007, with responsibility for initiating the Custom Manufacturing Solutions (CMS) business. He is currently responsible for all marketing, information technology (IT), and business development activities along with oversight of R&D.

Videos

Pharmaceutical Technology® spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers. 

Provepharm announced on Jan. 24, 2025 that it has voluntarily recalled one lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) because a customer found a visible black particulate matter in a single-sealed vial. The recalled product is packaged in 10 mL, single-dose vials with national drug code 81284-213-01, lot number 24020027, and an expiration date of December 2025. It was distributed nationwide in the United States.

Phenylephrine hydrochloride Injection is used to treat hypotension resulting from vasodilation in the setting of anesthesia. Injecting product that contains particulates may cause local irritation and swelling.

“If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death,” the company stated in the press release (1).

The company advised wholesalers, distributors, compounders, and hospitals to immediately stop using the product and return it to Provepharm’s recall provider, Sedgwick. While the company states it has not yet received any reports of adverse events associated with the recall, these events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

Packaging problems, such as particulates and defective vials, are a common cause of product recalls. These recalls can be hazardous to the health of patients but can also be expensive for companies to resolve and prevent. In September 2024, Gilead recalled one lot of Veklury (remdesivir) for Injection 100 mg/vial after a customer complaint of a glass particle found in a vial. An investigation performed by the company confirmed the presence of the glass particulate. While at the time of the recall the company had not received reports of any adverse events associated with the recall, if administered, the glass particulate could travel to organs and blood vessels, causing stroke or death.

, Dirk Margosch, vice president visual inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, discussed steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (3). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences, according to Margosch.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

FDA. Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter. Press Release. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp

FDA. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle. Press Release. 

Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. 

https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Provepharm Recalls Phenylephrine Hydrochloride Injection

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection. A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.

Click the video above to watch Dr. Margosch answer the following question:

“My company recently had critical incidental findings in several vials during secondary packaging. What can be done to minimize the risk of future market batches containing defective units?”

Dr. Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging, Vetter Pharma-Fertigung GmbH & Co KG

Dr. Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter, a global CDMO specializing in aseptic filling and packaging of injection systems. Margosch holds a degree in food science. He joined Vetter more than 15 year ago and has held various positions in the field of visual inspection and packaging.

Dr. Margosch joined the pharmaceutical service provider Vetter Pharma-Fertigung GmbH & Co KG in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

ACG, a supplier of integrated solutions for the pharmaceutical and nutraceutical markets, announced on Jan. 20, 2025 that it will be showcasing its line of sustainable packaging solutions at Pharmapack Europe, which is being held from Jan. 22–23, 2025 in Paris. ACG will be exhibiting at Stand E104, Hall 7.2.

During Pharmapack Europe, ACG will be highlighting their CelluPod paper-based, recyclable, and compostable blister system for products that require low water vapor transmission rates (WVTR). The company is also featuring its packaging solutions that are free of polyvinyl chloride (PVC). These include its PVC and Halogen-Free Thermoforming Blister System for products requiring low to medium WVTR. ACG also provides an eco-friendly alternative in its Bio D PVC. The company’s Halogen-Free Cold Form Blister System also provides a high-performance sustainable solution without halogen and PVC.

The company also announced its new head of Global Sales for ACG Packaging Materials, Jochen Scheil. With a background in mechanical engineering and more than 20 years of experience in large sales and service organizations in Europe, Asia Pacific, and the Middle East, Scheil previously held roles at Windmoeller & Hoelscher and Uhlmann Pac-Systeme.

"Joining ACG Packaging Materials at such a pivotal time is an incredible opportunity. I am thrilled to contribute to the company’s mission of driving innovative, sustainable packaging solutions globally,” said Scheil in the press release (1). With the launch of these products and our ongoing commitment to reducing emissions, ACG is setting a new standard for sustainability in the pharmaceutical industry."

"We’re delighted to welcome Jochen to the team. His leadership and vast experience in pharmaceutical packaging, combined with the efforts of his team in showcasing our sustainable products and processes, will play a crucial role in advancing our European expansion,” said Sheikh Akbar Ali, general manager, Development and Technology of ACG Packaging Materials, in the release.

At the Pharmapack event, ACG will also unveil its new state-of-the-art warehouse and slitting facility, which is located at its European site in Croatia.

 sat down Anil Andrade, vice-president of Global Sales at ACG World, during CPHI Milan to discuss growth in demand in the pharma industry and efforts put forth to achieve sustainable operations. In the interview, Andrade talked about the changing perceptions of the industry and the importance of sustainability in pharmaceutical operations. During the past 10 to 15 years, ACG has seen global growth in demand, and more so in Europe, North America, and Asia. Andrade also emphasized efforts to achieve sustainability to reduce the impact on the environment (2).

“Manufacturing capsules consumes a lot of water, and we have been trying to make our operations more efficient so that they consume less water, less paper, less plastic. In Croatia, as an example, we have reduced the paper consumption by almost 25 tons in a year. Same with plastic, we have reduced the consumption of plastic by 25 tons, and that has related to the benefits that we see going forward,” Andrade explained.

Listen to the full interview with Andrade at 

https://www.pharmtech.com/view/cphi-milan-2024-growth-and-sustainability-in-the-pharma-industry

ACG. ACG to Showcase Sustainable Packaging Innovations at Pharmapack Paris 2025. Press Release. Jan. 20, 2025.

Thomas, F. CPHI Milan 2024: Growth and Sustainability in the Pharma Industry. Oct. 18, 2024. https://www.pharmtech.com/view/cphi-milan-2024-growth-and-sustainability-in-the-pharma-industry

The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.

ACG to Showcase Sustainability Innovations at Pharmapack Europe 2025

Gerresheimer announced on Jan. 20, 2025 that it will be presenting its portfolio of containment, drug delivery, and digital solutions alongside Bormioli Pharma at Pharmapack 2025, which is being held from Jan. 22–23 in Paris, France. The two companies are exhibiting together following Gerresheimer’s acquisition of Bormioli, which was finalized in December 2024.

At the event, Gerresheimer will be featuring its primary packaging solutions and delivery systems for sensitive biologics, such as its EZ-fill Smart packaging platform for ready-to-fill (RTF) vials and cartridges. Gerresheimer’s Gx Elite syringes, cartridges, and vials offer protection for injectable drugs, especially novel biologics, says the company.

Also highlighted will be the company’s self-injectable devices, including the Gx Inbeneo auto-injector and the Gx SensAir on-body drug delivery device. “Both devices enable simple, patient-friendly application with high-precision dosing of the respective medication. The on-body drug delivery device can optionally be digitally connected and integrated into digital health platforms,” the company stated in a press release (1).

Gerresheimer will also provide a first look at their new digital solution for adherence support in clinical trials in the Innovation Gallery during a presentation by Sueyoung Yoon on January 23 at 11:40 a.m. “If medication is not taken as intended, this could affect data integrity, trial efficiency and the safety of trial participants. Gx Cap for Clinical Trials is a digitally connected tablet container cap, which enables the monitoring of oral medication intake so that trial participants can be reminded to take their medication if necessary. Gx Cap is already being used successfully by pharmacies in the US for remote therapeutic monitoring programs for certain therapeutic areas,” the company stated in the press release.

Experts from Gerresheimer will also be participating in presentations in the event’s Learning Lab and Sustainability Theater. Adrian Johnson will be giving a presentation, “Reducing the Carbon Footprint of our Products—Renewable Energy and Material Innovation as Viable Solutions” on January 22 at 12:55 p.m. in Sustainability Theater K85. Bernd Zeiss will be co-presenting, “A Partnership Worth More Than the Sum of Its Parts—Device Component Manufacturers Fulfil Syringe and System Performance Requirements”, in Learning Lab K3 on January 23 at 10:10 a.m., and Holger Krenz will be presenting “The innovation journey: Developing EZ-fill Smart as the New Industry Standard for Ready-to-Use Vials” on January 23 at 2:30 p.m. in Learning Lab K3.

Gerresheimer is a systems and solutions provider for the pharma, biotech, and cosmetic industries with a portfolio of drug containment solutions including closures and accessories and drug delivery systems. Their products include medication pumps, syringes, pens, auto-injectors, inhalers, vials, cartridges, ampoules, tablet containers, infusion, droppers, and syrup bottles. The company has more than 40 production sites in 16 countries in Europe, America, and Asia. Bormioli Pharma has a variety of pharmaceutical packaging solutions.

Gerresheimer and Bormioli Pharma can be found at booth F55 at Pharmapack in Paris Expo, Porte de Versailles from Jan. 22–23, 2025.

1. Gerresheimer. Two Stories–One Future. Gerresheimer and Bormioli Pharma at Pharmapack 2025. Press Release. Jan. 20, 2025.

The two companies will be exhibiting together after Gerresheimer’s December 2024 acquisition of Bormioli.