UniCycive Therapeutics Inc (UNCY)

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Unicycive Therapeutics (NASDAQ: UNCY) has no publicly disclosed contract supplier or manufacturing partner specifically for oxylanthanum carbonate (OLC) in the European Union as of November 13, 2025.
Unicycive's primary contract manufacturer for OLC is Shilpa Medicare Ltd. (an India-based CDMO), under a long-term supply agreement signed in 2020 and amended in 2024 for commercial-scale production (primarily to support U.S. launch and global needs).
A backup third-party vendor (unnamed in public filings) was referenced in 2025 FDA Complete Response Letter discussions, but no location or identity was specified for EU purposes.
OLC remains U.S.-focused, with the NDA under FDA review (resubmission expected by year-end 2025 after a manufacturing-related CRL).
No EMA filing or EU regulatory submission has been announced.
Ex-U.S. licensing deals are limited to Asia:Lee’s Pharmaceutical (China, Hong Kong, Macau)
Lotus Pharmaceutical (South Korea)

No partnerships, licensing agreements, or manufacturing arrangements for Europe/EU have been disclosed in press releases, SEC filings (10-K/Q), or investor materials.
Unicycive retains full rights outside its licensed Asian territories and may pursue EU opportunities post-U.S. approval, but nothing is confirmed currently.

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