Patented Lyobag technology offers enhanced administration safety, efficiency, and stability.
BRIDGEWATER, N.J., September 2, 2025 – Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal or the “Company”) today announced that it has begun U.S. commercialization of TEPADINA® (thiotepa) for Injection 200 mg in a patented multichambered bag. This new “Lyobag” presentation, developed and manufactured by ADIENNE Pharma & Biotech SA, a Swiss-based biopharmaceutical company focused on oncology and rare diseases, was FDA approved on April 10, 2025, for the same four indications as the existing vial presentation. The addition of the 200 mg multichamber bag format to the 15 mg and 100 mg vials broadens the company’s U.S. portfolio for this brand.
TEPADINA 200 mg is the first FDA-approved combination product to incorporate ADIENNE’s proprietary multichamber flexible container freeze-drying technology. This closed system allows for aseptic filling and lyophilization directly into the bag, providing a ready-to-infuse, needle-free format for administering cytotoxic drugs. The design is intended to enhance safety, simplify preparation and improve drug stability in clinical settings. The new bag presentation utilizes the same common J-code (J9340) used for existing thiotepa vial presentations.
Key benefits of the multichamber bag presentation include:
- Time savings: Ready-to-use, needle-free format eliminates the need for manual reconstitution and dilution steps, speeding up preparation.
- Improved safety: Closed system helps reduce the risk of dosing errors and protects healthcare professionals from exposure to cytotoxic agents.
- Reduced waste and cost: Limits the need for reconstitution equipment, hoods or cleanroom environments; supports combination therapies from a single device.
- Enhanced stability: Maintains product stability for up to 5–7 days when refrigerated and 56 hours at room temperature; the system preserves the efficacy and stability of the active ingredient throughout administration via its high-performance oxygen and moisture barrier.
Important Safety Information includes a Boxed Warning, “TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA. TEPADINA should be considered potentially carcinogenic in humans.” See package insert here.
“This innovative delivery system represents an important advancement in how cytotoxic therapies are prepared and administered,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Affordable Medicines, Amneal Pharmaceuticals. “We’re proud to bring this first-of-its-kind presentation of TEPADINA to healthcare professionals in the U.S., supporting safer and more efficient care through our partnership with ADIENNE.”
Product details are available at amneal.com/Tepadina. For more information on ADIENNE’s multichambered bag technology, visit Multichamber Flexible Bag – ADIENNE.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.
About ADIENNE
Adienne is a Swiss-based biopharmaceutical company committed to developing innovative treatment solutions in oncology, hematology, and rare diseases. With a focus on advanced drug delivery technologies and a strong R&D pipeline, ADIENNE aims to improve patient outcomes and support healthcare professionals worldwide. For more information, visit www.adienne.com.
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Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
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