Meitheal Pharmaceuticals Announces Recent Business Progress Reinforcing Commitment to Sustainable Generics Development

• Following expansion of its generic injectables portfolio in September 2023, Meitheal is preparing to launch up to 20 new products in 2024 to support a sustainable U.S. drug supply
• Recently launched multiple presentations of Bupivacaine Hydrochloride Injection which has experienced repeat shortages in recent years
• Since its founding in 2017, Meitheal has progressed more than 55 molecules through ANDA approval at reduced generic prices

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 recent progress for its generic injectables portfolio, underscoring the Company’s commitment to serve as a sustainable partner for generics development in the U.S.

“Meitheal is pleased to further expand our portfolio of sustainably manufactured and priced generic injectables as we bring additional presentations of Bupivacaine Hydrochloride Injection to market during this time of product shortage. As we prepare to launch multiple new products in 2024, we are intently focused on expediting delivery of medicines in short supply,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “With over $100 million invested in generic R&D over the past six years, Meitheal is fully committed to pursuing efficient drug development and commercialization to simplify access to life-changing medicines for all patients.”

Bupivacaine Hydrochloride Injection, USP is an anesthetic used for surgical, diagnostic, therapeutic, and obstetrical procedures. As of March 1, 2024, both the U.S. Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) websites list multiple presentations of Bupivacaine Hydrochloride Injection on drug shortage.

Capital investment of over $100 million by Meitheal’s parent company Nanjing King Friend Biochemical Pharmaceutical Co., Ltd. (NKF) for a brand new, state-of-the-art manufacturing workshop was completed in 2023 and inspected by the FDA in November of 2023 resulting in approval of five new lines. These approved lines add over 200 million units of capacity for vial and cartridge products that support current and future demand for generic injectables. These lines are expected to produce commercial products that will have an impact on drug shortages beginning in the second half of 2024.

Meitheal is planning for the launch of multiple new products in 2024 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.

ABOUT BUPIVACAINE HYDROCHOLORIDE FOR INJECTION, USP

Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia. For full prescribing and safety information, please click on the following link.

Learn more about Bupivacaine Hydrochloride Injection, USP

ABOUT MEITHEAL PHARMACEUTICALS

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and biosimilar products. Meitheal currently markets over 55 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of February 2024, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 20 products planned for launch in 2024, and an additional 19 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 among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF)

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.

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