C2 PHARMA, the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs) globally, is expanding its global access to its portfolio of active pharmaceutical ingredients (APIs) with new regulatory submissions and approvals.
Earlier this year, they received a CEP for cyclopentolate hydrochloride and recently a C-DMF for digoxin, demonstrating their commitment to becoming the leader in ophthalmic and niche APIs.
“As we deepen our involvement in the ophthalmic sector, our ability to successfully submit and secure numerous regulatory filings worldwide will enable us to better serve a truly global customer base in need of high-quality APIs,” states Andrew Badrot, CEO of C2 PHARMA.
“I am very proud of what my team has been able to achieve and look forward to seeing how we bring this energy into the upcoming years with the pending launch of oxybuprocaine (benoxinate hydrochloride) API in Q1-2024.”
Along with the C-DMF and CEP approvals, the filings continue to grow across C2 PHARMA’s API portfolio. The most recent submissions include
- brimonidine tartrate (CADIFA under submission)
- bitmatoprost (Canadian-DMF under submission)
- pilocarpine hydrochloride micronized (Korean K-DMF under submission)
- tropicamide (China C-DMF under submission).
As they progressively expand their portfolio of ophthalmic APIs, C2 PHARMA has signed an agreement with an additional CMO partner, SMS Lifesciences.
This strengthens their manufacturing network and accelerates their path towards bringing their R&D portfolio of ophthalmic products to the commercial market.
“We believe in forging long-term relationships with organisations that share our passion for quality, reliability and excellence,” says Dr James Lawler, General Manager of C2 PHARMA.
“With the addition of SMS Lifesciences to our CMO network, we are confident in our ability to deliver exceptional pharmaceutical ingredients with the best cost-to-quality to meet the healthcare needs of patients worldwide.”
