C² PHARMA Expands API Portfolio with Global Regulatory Access Ahead of CPhI Barcelona

Cork, Ireland, 17th October 2023 –  C² PHARMA, the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs) globally, is expanding their global access to their portfolio of active pharmaceutical ingredients (APIs) with new regulatory submissions and approvals. Earlier this year they received a CEP for Cyclopentolate Hydrochloride and recently 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

A full list of products and their filings can be found here, with the R&D pipeline available here. 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 organizations 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.”

The company will be exhibiting at CPhI Worldwide 2023 in Barcelona from the 24^th to the 26^th of October 2023 in Hall 4, Booth D49 with its affiliates, Logisitics4Pharma and ASM Research Chemicals. To schedule a meeting please reach out to info@c2pharma.com.