C2 PHARMA successfully completes validation campaigns for digoxin and digoxin micron
- Validation campaigns for both digoxin and digoxin micron APIs have
been successfully completed.
- Samples available in the fourth quarter of 2018.
- CEP and DMF filings to be submitted to authorities in Q1 2019 and Q2
Luxembourg, October 4, 2018 – C2 PHARMA (Hall 6, Booth 6F40) has
successfully validated its manufacturing process for two APIs: digoxin
and digoxin micron. Digoxin is produced at a dedicated manufacturing facility
at CMO Laurus Labs, India.
C2 PHARMA invested in a state-of-the-art, dedicated production facility for the
manufacture of digoxin at the Laurus Labs site in Vizag, India, in May 2017.
The total investment in the facility is close to US$ 10 million and the facility,
which covers an area of more than 1800 m2, will have an annual production
output covering the global demand for digoxin.
“Within 24 months, C2 PHARMA and Laurus Labs have been able to complete
the construction of the civil works, install and validate the manufacturing
equipment, design and validate the manufacturing process and prepare the
filing for the regulatory dossier for the two APIs,” said Andrew Badrot, CEO
of C2 PHARMA. “This is an astonishing performance and a testament to the
partnership that exists between the two companies.”