- Meitheal’s Alprostadil Injection, USP Single Dose Glass Vials (500 mcg/mL) are AP rated to PROSTIN VR® (alprostadil) an ampoule form product.
- Alprostadil Injection, USP is primarily offered in ampoule form, making Meitheal’s vial an exclusive option for the 500 mcg/mL strength.
- Meitheal’s Alprostadil Injection, USP vial form offers the opportunity of a safer alternative to ampoules for handling by healthcare providers and administering medicine to patients.
Chicago, IL – March 13, 2025 – Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and biosimilar products, today announced availability of Alprostadil Injection USP Single Dose vials to the US market where only an ampoule form is offered, demonstrating the Company’s commitment to be a strategic partner supplying safe and sustainable medications.
"Meitheal is proud to expand its portfolio of sustainably manufactured and affordably priced generic injectables with the introduction of Alprostadil Injection, USP in vial form. Amid ongoing product shortages, we are committed to accelerating the availability of critical medicines and launching the sole vial presentation for the 500 mcg/mL strength, which may offer healthcare providers a safer alternative for handling and administration to patients," said Brett Novak, SVP of Commercial Operations at Meitheal Pharmaceuticals. "With over $100 million invested in generic R&D over the past six years through our parent company, Nanjing King Friend (NKF), Meitheal remains dedicated to advancing efficient drug development and commercialization to improve patient access to life-changing treatments."
Alprostadil Injection, USP is a vasodilator used for palliative therapy to temporarily maintain the patency of ductus arteriosus until surgery can be performed in neonates who have congenital heart defects and depend on the patent ductus for survival. Alternatively, to the glass ampoule, Meitheal’s unique offering of the vial form has the potential to offer safer usage and administration of medication. Glass ampoules are widely used to contain injection medications because of their non-reactive properties.1 However, the contamination of medication contents by glass particles is a common phenomenon following the manual opening of glass ampoules1, 2. Such contaminated medication, if used, could lead to glass particle circulation in a patient’s blood, which can further lead to complications such as pulmonary emboli, infusion phlebitis, granuloma formation or nodular liver fibrosis.3 Similarly, the sharp and jagged edges from opening ampoules have been documented to cause hand lacerations among healthcare workers, which pose potential risks to tendons and nerves.1,4
Meitheal is planning for the launch of multiple new products throughout 2025 across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology by continuously evaluating new product opportunities and prioritizing those that address gaps in the current marketplace.
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ABOUT ALPROSTADIL INJECTION, USP
Alprostadil Injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transportation of the great vessels with or without other defects.
In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment p92 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response.
Alprostadil Injection USP should be administered only by trained personnel in facilities that provide pediatric intensive care.
For full prescribing and safety information, please click on the following link.
Learn more about Alprostadil Injection, USP
1 Stoker R., Preventing Injuries from Glass Ampoule Shards, Managing Infection Control (October
2009),https://sofia.medicalistes.fr/spip/IMG/pdf/Preventing_injuries_from_glass_ampoule_shards.pdf
2 Zabir, A., Choy, C., & Rushdan, R. (2008). Glass particle contamination of parenteral preparations
of intravenous drugs in anesthetic practice. Southern African Journal of Anesthesia and
Analgesia, 14(3), 17–19. https://doi.org/10.1080/22201173.2008.10872550
3 Chiannilkulchai N., Kejkornkaew S., Safety concerns with glass particle contamination: improving
the standard guidelines for preparing medication injections. Int J Qual Health Care.
2021 Jun 23;33(2):mzab091. doi: 10.1093/intqhc/mzab091. PMID: 34101800; PMCID: PMC8221140.
4 Parker, M.R.J. (1995), The use of protective gloves, the incidence of ampoule injury and the
prevalence of hand laceration amongst anesthetic personnel. Anesthesia, 50: 726-
729. https://doi.org/10.1111/j.1365-2044.1995.tb06105.x
PROSTIN VR® (alprostadil) is a registered trademark of Pfizer
ABOUT MEITHEAL PHARMACEUTICALS
Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good.
Learn more about who we are and what we do at https://www.meithealpharma.com.
ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion.
MEDIA CONTACT
Meitheal Pharmaceuticals, Inc.
John Spilman, VP of Corporate Strategy
773 899 5910
info@meithealpharma.com
