11 March 2024 | Monday | News
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Oxybuprocaine (also known as Benoxinate), is a local topical anesthetic used especially in ophthalmology and otolaryngology for short term medical procedures. We are completing the validation process, by April 2024, and upon completion, GMP samples will be available to our customers worldwide for evaluation and testing.
We expect 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 meeting 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.”
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