C2 PHARMA, a pharmaceutical group focused on manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs) globally, is expanding their API product portfolio. Tropicamide API is launching with regulatory filings in both Europe and the USA planned for November 2022. GMP validation samples and commercial supply for Tropicamide API are currently available.
Additionally, filings have been completed with the USFDA to switch the ownership for three drug master files (DMFs) of the key ophthalmic APIs: Brimonidine, Latanoprost and Bimatoprost. These APIs will now be supervised by C2 PHARMA’s internal quality oversight team and supplied to the market under its own brand.
“Each API we offer undergoes detailed QA review for the manufacturing and testing activities of every batch. A unique cost-to-quality strategy allows us to deliver exceptional quality APIs to our customers while designing our supply chain to be resilient” said Andrew Badrot, CEO of C2 PHARMA. “Though COVID-19 was a challenge, it ultimately strengthened our commitment to operational excellence, and pushed us to make these portfolio additions. We will continue taking a strategic approach to investing in quality and building our reputation as the leading supplier of ophthalmic APIs globally.”
The global reach of regulatory filings is also growing across C2 PHARMA’s API portfolio in Asia and South America. All the most recent filings and approvals include:
Cyclopentolate Hydrochloride (launched successfully end of 2021)
- US-DMF available for reference
- CEP expected imminently
- China C-DMF under submission
Brimonidine Tartrate
- US-DMF available for reference
- CEP filed March 2022
- ASMF Available for reference
- Korea K-DMF filed September 2022
- China C-DMF filed January 2022
Latanoprost
- US-DMF available for reference
- CEP under submission
- Korea K-DMF filed September 2022
- China C-DMF available for reference
Bimatoprost
- US-DMF available for reference
- ASMF Available for reference
- Korea K-DMF under submission
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