C2 PHARMA Expands Eye Care Solutions With New API Launch

C2 PHARMA, a global leader in ophthalmic and niche APIs, has introduced Naphazoline Hydrochloride as its newest offering. Following the completion of its validation process in June 2024, the company is awaiting approval for a Certificate of Suitability (CEP). Additionally, they plan to submit a US Drug Master File (US-DMF) by November 2024, with a dossier for Brazil (DIFA) set for December 2024. Known for relieving red eyes and nasal congestion, Naphazoline HCL is versatile for use in both prescription and over-the-counter products. The API will be manufactured by SMS Lifesciences, one of C2 PHARMA’s contract manufacturing partners based in India.

“We transferred Naphazoline Hydrochloride to SMS Lifesciences to enhance C2 PHARMA’s speed and throughput in developing new API’s and to boost our production capacity. GMP samples are now available to our customers worldwide to support their validation efforts,” stated James Lawler, General Manager of C2 PHARMA.

Andrew Badrot, CEO of C2 PHARMA, said in a statement, “We pride ourselves on the quality and reliability of our network of CMO partners. With the addition of SMS Lifesciences, we can speed up the roll-out of our ophthalmic API pipeline. The plan is to accelerate the delivery of high-quality and best cost-to-quality active pharmaceutical ingredients to the global market with the upcoming release of Timolol Maleate, Dorzolamide, and Brinzolamide over the next 24 months.”