Ciprofloxacin/Dexamethasone

First Prescription Ear Drop Suspension Advances Portfolio Diversification Strategy Maple Grove, MN – April 6, 2026 – Upsher-Smith Laboratories, LLC (Upsher-Smith), a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX) today announced the recent launch of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP. According to IQVIA, the Ciprofloxacin and Dexamethasone Otic Suspension market had U.S. sales of approximately $118 million*. “The introduction of Upsher-Smith’s first prescription ear drop suspension reinforces our strategic focus on expanding and diversifying our generics portfolio to support sustainable, long-term growth,” said Jim Maahs, Senior Vice President, Head of Upsher-Smith Commercial. “By adding Ciprofloxacin and Dexamethasone Otic Suspension, we continue to strengthen our presence in differentiated dosage forms while delivering options that meet the needs of our customers and the patients they serve.” The Therapeutic Equivalence (TE) code for Upsher-Smith’s Ciprofloxacin and Dexamethasone Otic Suspension product is AB, and the Reference Listed Drug (RLD) is the brand Ciprodex®**. Product Information Product Strength NDC # Package Sizes Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP 0.3%/0.1% 0832-1430-75 7.5 mL Product Strength NDC # Package Sizes Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP 0.3%/0.1% 0832-1430-75 7.5 mL For questions about ordering, please call Upsher-Smith at 1-800-654-2299. Please refer to the full Prescribing Information for Ciprofloxacin and Dexamethasone Otic Suspension here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch. About Upsher-Smith Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com. About Bora Founded in 2007, Bora Pharmaceuticals (“Bora” or “the Company”, 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of “Contributing to Better Health All Over the World”. Operating under a “Dual Engine” model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients’ quality of life. By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success “certain,” Bora sets new standards in the pharmaceutical and CDMO industries. For more, please visit: https://www.bora-corp.com and https://www.boracdmo.com. *December 2024 through November 2025. **Ciprodex is a registered trademark of Bayer AG. We’re hiring Search Our Jobs You are now leaving Upsher-Smith.com Upsher-Smith Laboratories, LLC is not responsible for content or policies on linked sites.

Amneal aims to develop an affordable, complex, high-value product for bacterial ear infections. Credits: goodlux/Shutterstock.com. Amneal Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for its ciprofloxacin and dexamethasone otic suspension, a generic drug of Novartis ’ Ciprodex (ciprofloxacin/dexamethasone), for the treatment of ear infections. With the FDA approval, the New Jersey-based pharma company will develop an affordable, complex, and high-value product that reflects the “diversification of [the] business” and its evolving portfolio, said Amneal’s generics executive vice-president Andy Boyer in the 25 March press release. An approved ANDA allows a sponsor to manufacture and market a safe and effective generic product at a lower cost than the brand-name product it references. Ciprodex is designed to prevent bacterial DNA replication and the growth of new bacteria via the antibiotic ciprofloxacin. It suppresses inflammation by inhibiting the synthesis of cytokines associated with inflammation. As per its label, the drug is indicated to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis media (AOM) and acute otitis externa (AOE) in patients aged six months and older. Novartis reported a 62% rise in net income in 2023, increasing from $6.04bn to $8.6bn on constant currencies. See Also: J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction Takeda’s ADZYNMA gains Japanese approval for cTTP treatment Amneal is among several companies marketing generics of Novartis’ combination ear drop medication. India-based Dr Reddy’s launched its Ciprodex generic after receiving FDA approval in August 2020.