News

WE LIKE TO KEEP YOU UPDATED

C2 PHARMA Completes Multiple Regulatory Filings, Expands API Portfolio

Luxembourg, February 23, 2021 – C2 PHARMA, a pharmaceutical group established in 2014 focused on niche active pharmaceutical ingredients (APIs), has expanded its portfolio of APIs and botanical extracts throughout 2020 and will continue pursuing the expansion into 2021. Multiple regulatory filings have been submitted to expand distribution channels globally across China, Taiwan, South Korea, Brazil, and Mexico.

Since announcing our intentions to go through a growth spurt at CPhI Worldwide in 2019 we have been actively working to deliver on these promises with a range of regulatory filings. Our goal is to be a reliable, quality focused partner for ophthalmic pharmaceutical companies”, said Andrew Badrot, CEO of C2 PHARMA (C2P). “I am proud of our team and what we are accomplishing for our customers. In less than seven years from being founded, C2P has established an API portfolio with over ten US-DMF and CEP filed in addition to all the local filings we are announcing today, and we have been able to maintain operational excellence and expand our portfolio amid the COVID-19 pandemic”.

 

Recent filings include:

Atropine Sulfate:

  • China C-DMF published December 2020
  • Taiwan T-DMF granted in December 2020

Atropine (Base):

  • US DMF to be filed by March 2021
  • CEP filed in December 2020

Homatropine Hydrobromide API:

  • US DMF filed in April 2020
  • CEP filed in April 2020

Homatropine Methylbromide:

  • Taiwan T-DMF granted in December 2020

Digoxin (Micron), manufacturing site Laurus Labs Limited:

  • US DMF available for reference as of April 2020
  • CEP filed in November 2019

Digoxin, manufacturing site Nobilus Ent:

  • China C-DMF published in January 2021
  • Korea K-DMF filed in October 2020

Digoxin (Micron 10), manufacturing site Nobilus Ent:

  • US DMF Amended to include Micron 10 grade filed in October 2020
  • CEP to be filed in March 2021

A full list of products in the C2 PHARMA portfolio can be found here with R&D insights here.

About C2 PHARMA

C2 PHARMA is a pharmaceutical group established in 2014. The company focuses on developing APIs that are niche, complex, difficult to manufacture, challenging to sell or to transport by combining best-in-class manufacturing, quality oversight and technical expertise. The current API product portfolio includes atropine, digoxin, homatropine, pilocarpine, hyoscine butylbromide. Customized GDP cold-chain logistics solutions are offered through a specialized affiliate, Logistics4Pharma. R&D-scale contract synthesis services, analytical services, phytochemical profiling, and impurities manufacturing are provided via its affiliate, ASM Research Chemicals.

Corporate Contact
Marcelo Reinhardt
marcelo.reinhardt@c2pharma.com
tel: +352 28 26 11 00

Media Contact
Beth Willers
White Matter Communications
bethw@whitemattercomm.com