Alembic Therapeutics Acquires NUVESSA Metronidazole Vaginal Gel 1.3% from Exeltis USA

Product transfer obligations now sit with Alembic Therapeutics, LLC following its acquisition of NUVESSA® (metronidazole vaginal gel 1.3%) from Exeltis USA, Inc., a shift that places GMP compliance, labeling continuity, and distribution accountability squarely under new commercial ownership. For QA directors and regulatory affairs leads managing the receiving side of branded transfers, the transaction signals an immediate review cycle across batch records, approved suppliers, and post-market commitments tied to the existing NDA.

NUVESSA carries FDA approval for the treatment of bacterial vaginosis in females 12 years of age and older, delivered as a single-dose, pre-filled disposable applicator containing approximately 5g of gel with 65mg of metronidazole administered intravaginally once daily at bedtime. The single-dose format constrains process validation scope but does not reduce the regulatory surface area: contraindication language covering hypersensitivity to metronidazole, parabens, and other nitroimidazole derivatives must carry forward without deviation into any revised labeling or promotional materials Alembic issues post-close.

Under 21 CFR Part 211, the incoming owner assumes full responsibility for manufacturing controls, stability data stewardship, and annual product review obligations from the transfer date. Where contract manufacturing arrangements remain in place from the Exeltis era, Alembic's QA team will need to qualify those relationships against its own quality agreement standards and confirm that any existing ICH Q10 pharmaceutical quality system documentation is updated to reflect the change in commercial ownership. Supply chain continuity for retail and specialty pharmacy channels is confirmed, but distribution agreements will require re-execution under Alembic's legal entity.

Alembic Therapeutics is headquartered in Bedminster, N.J., and positions the acquisition as an expansion of its women's health portfolio. No financial terms were disclosed. The company has not indicated whether manufacturing will be transferred to an Alembic-operated facility or retained at the existing contract site, a detail that will determine the scope of any supplemental NDA filing required under 21 CFR Part 314.

The pace at which Alembic files any necessary post-acquisition supplements with FDA will serve as the first measurable indicator of how smoothly the regulatory transfer has been executed.

Source: GlobeNewswire via Alembic Therapeutics, LLC press release, June 9, 2026.