Replies to post #2572 on UniCycive Therapeutics Inc (UNCY)

[Whalatane]

Nope ...I think the subcontractor with the cGMP issue is in India....from Gemini

Unicycive Therapeutics (UNCY) utilizes Shilpa Medicare Limited as its primary manufacturing and supply partner for Oxylanthanum Carbonate (OLC). While the specific location of the subcontractor facility that recently faced FDA compliance issues was not named in public filings, the following details are confirmed regarding the manufacturing network:

Manufacturing Partner: Unicycive has a formal agreement with Shilpa Medicare for OLC manufacturing. In 2024, Unicycive committed funding to Shilpa for the construction of a new manufacturing line to meet OLC demand.
Subcontractor Compliance Status: In June 2025, the FDA issued a Complete Response Letter (CRL) citing compliance deficiencies at a third-party manufacturing subcontractor facility.

These deficiencies were primarily related to final finishing and packaging operations rather than the active pharmaceutical compound.

Resolution and Resubmission: The "original third-party manufacturing vendor" worked to resolve these deficiencies throughout late 2025. Notably, the vendor was inspected by EU regulatory authorities during this period with no deficiencies identified.

Kiwi