The addition of this API will extend the company's range of high-quality ophthalmic APIs and strengthen its commitment to meeting the market's evolving needs.
Oxybuprocaine (also known as Benoxinate), is a local topical anaesthetic used in ophthalmology and otolaryngology for short-term medical procedures.
C2 PHARMA is completing the validation process and, on completion, GMP samples will be available to customers worldwide for evaluation and testing.
THe company expects to submit a Certificate of Suitability (CEP) by May 2024, a US Drug Master File (US-DMF) by August 2024 and a Certificate of Acceptance of Drugs and Food (CADIFA) in Q4 of 2024.
“At C2 PHARMA, we understand the importance of being able to deliver ophthalmic APIs that meet the highest quality standards and the best cost-to-quality and cost-to-reliability in the industry."
"We are committed to providing our customers with the most dependable service level for ophthalmic APIs,” states Andrew Badrot, CEO of C2 PHARMA.
“We will further be expanding our range of high quality ophthalmic APIs throughout 2024, with our next release being naphazoline hydrochloride.”
