C2 PHARMA has introduced its latest API, Naphazoline Hydrochloride, expanding its ophthalmic API portfolio.

The validation campaign for Naphazoline HCL was completed in June 2024, and a Certificate of Suitability (CEP) is already under approval while the US-Drug Master File (US-DMF) is planned for submission by November 2024 and the API dossier for Brazil (DIFA) in December 2024.

Naphazoline HCL is effective in alleviating red eyes and nasal congestion, making it suitable for both prescription and over-the-counter products. This API will be produced by one of their CMO partners, SMS Lifesciences.

“We transferred Naphazoline Hydrochloride to SMS Lifesciences to enhance C2 PHARMA’s speed and throughput in developing new APIs and to boost our production capacity,” states James Lawler, General Manager of C2 PHARMA.

“GMP samples are now available to our customers worldwide to support their validation efforts,” he added.

“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,” states Andrew Badrot, CEO of C2 PHARMA.

“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," added Badrot.