Claris Lifesciences Limited (Claris) announced today that it has received an in-principle approval for its block buster drug; Propofol; in the European Union (EU). This will allow the company to process the registration across 25 countries in the EU.
Propofol; a flagship product of Claris; is an anaesthetic product which is widely replacing other anaesthetic drugs, as recovery from Propofol is more rapid and clear when compared to other anesthetic drugs. The molecule involves a complex manufacturing technology, and has few competitors world wide.
Europe has one of the most complex procedures for obtaining regulatory approvals and Claris is one of the few companies to have received approval for Propofol in Europe.
The market size for Propofol is estimated to be at USD 750 Mn world wide and in EU is estimated to be about USD 150 Mn. Claris is one of the few companies to have the competence to manufacture this product on a large scale and has one of the largest manufacturing capacities in India. This registration will benefit Claris as EU is a lucrative market both in terms of revenue and margins. Going ahead, Propofol in EU would be a very big growth driver for Claris.
Claris has already received 125 approvals in Europe, while another 105 are in the pipeline. Further, it has received 95 approvals for Propofol across different geographies and another 60 registrations are in the pipeline.
About Claris Lifesciences Limited
Claris Lifesciences Limited is one of the largest sterile injectables pharmaceutical companies in India with a market presence across 76 countries. The company manufactures and markets products across various therapeutic segments including Anaesthesia, Plasma Volume Expanders, Blood Products, Parenteral & Enteral Nutrition, Infusion therapy, Anti-infectives, Renal Care, and Oncology. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses.
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With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology-driven injectable products across delivery systems such as glass & plastic bottles, glass vials & ampoules, and non-PVC/PVC bags. Claris’ sterile injectables facilities have been approved by regulatory authorities including USFDA, MHRA (UK), TGA (Australia), and GCC FDCA. The company’s manufacturing capabilities have several times received awards from prestigious institutions like Frost & Sullivan and IDMA.
For more information about the company, log on to www.clarislifesciences.com
Disclaimer
This press release may include "forward-looking statements" which involve a number of risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future. Claris Lifesciences Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof. Market information mentioned herein is based on external sources and internal estimates. The company does not guarantee the accuracy of the market information.