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Breaking News, Trials & Filings

C2 Pharma Expands Its Portfolio of APIs

Completes multiple local regulatory filings to grow distribution channels.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

C2 Pharma, a pharmaceutical group focused on niche active pharmaceutical ingredients (APIs), has expanded its API product portfolio.
 
Multiple regulatory filings have been submitted to expand distribution channels globally across China, Taiwan, South Korea, Brazil, and Mexico. In addition, the company has successfully launched a Cyclopentolate Hydrochloride API in both the U.S. and European markets to position the team as a leading ophthalmic API supplier. 
 
“Since announcing our intentions to go through a growth spurt back in 2019 at the last live edition of CPhI Worldwide pre-COVID, we have been actively working to deliver on our promises. Our team is driven to offer the most reliable, quality focused products and support to our customers,” said Andrew Badrot, CEO of C2 Pharma. “Since inception in 2014, C2 Pharma has rapidly grown an API portfolio with over ten US-DMF and CEP filed in addition to all the local filings we are announcing today. COVID-19 has strengthened our commitment to operational excellence, and we are thrilled to be able to make so many strategic portfolio additions.”

Recent filings include:

1. Atropine Sulfate
  • China C-DMF published on the CDE Website December 2020
  • Taiwan T-DMF granted in December 2020
 
2. Atropine (Base)
  • US DMF filed in May 2021
  • CEP filed in December 2020
 
3. Homatropine Hydrobromide API
  • US DMF filed in April 2020
  • CEP filed in April 2020
 
4. Homatropine Methylbromide
  • Taiwan T-DMF granted in December 2020
 
5. Digoxin (Micron) at manufacturing site, Laurus Labs Limited
  • US DMF available for reference as of April 2020
  • CEP granted in October 2021
 
6. Digoxin at manufacturing site, Nobilus Ent
  • China C-DMF published on CDE Website January 2021
  • Korea K-DMF filed in September 2020
 
7. Digoxin (Micron 10) at manufacturing site Nobilus Ent
  • US DMF Amendment to include Micron 10 grade filed in October 2020
  • CEP granted in August 2021
 
8. Pilocarpine Hydrochloride
  • Korea K-DMF filed in March 2021
 
9. Pilocarpine Nitrate
  • China C-DMF published on CDE Website October 2021
 
10. Cyclopentolate Hydrochloride
  • US DMF & CEP filed in October 2021
 
A full list of products in the C2 Pharma portfolio can be found here.

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