C2 Pharma has expanded its ophthalmic API portfolio with the launch of brinzolamide, following the successful completion of its process validation campaign in September 2026.
The company has also filed a US Drug Master File (US-DMF) for the carbonic anhydrase inhibitor to support regulatory requirements for the API.
Brinzolamide is used to reduce elevated intraocular pressure in patients with glaucoma or ocular hypertension.
The API is commonly formulated as a topical ophthalmic suspension and can be used as a monotherapy or alongside other intraocular pressure-lowering treatments.
Expanding ophthalmic API portfolio
C2 Pharma said that it is working with Haleos Labs (formerly SMS Lifesciences) to manufacture brinzolamide.
The partnership is intended to provide manufacturing capacity and support supply continuity for pharma customers.
The launch follows a series of portfolio and regulatory developments for C2 Pharma during the past year.
In March, the company launched dorzolamide hydrochloride, another carbonic anhydrase inhibitor used in ophthalmology, after completing its process validation campaign.
C2 Pharma subsequently secured Certificates of Suitability (CEPs) for naphazoline hydrochloride and naphazoline nitrate in April, extending its regulatory coverage for ophthalmic APIs.
The company's current portfolio includes APIs such as atropine sulphate, bimatoprost, brimonidine tartrate, latanoprost, timolol maleate and dorzolamide hydrochloride, alongside its newly launched brinzolamide.
C2 Pharma will showcase its portfolio at this year's CPHI Milan show, taking place from 6-8 October.
