CimetrA import approval granted in India
LONDON, UK: MGC Pharmaceuticals, a European based bio-pharma company specialising in the production and development of phytomedicines, has been granted a permit to import CimetrA™ into India by the Indian Central Drugs Standard Control Organisation (CDSCO) to facilitate final product testing to complete its application for Emergency Use Authorisation to treat patients with COVID-19.
The application for Emergency Use Authorisation by CDSCO has been co-ordinated by P.T.K. Consulting Ltd (PTK), an Israeli consulting company operating in the fields of Medicine, Medical technology, and Pharmaceuticals. Medopharm, one of the leading manufacturers of pharmaceutical products in India, has been appointed to import and market CimetrA™ in India.
The Emergency Use Authorisation allows local regulators to help strengthen the nation’s public health protections against chemical, biological and other threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies.
Medopharm has over 50 years of experience of in-house development and licensing of medicinal products and will use this experience to manage the Marketing Authorisation approval process for CimetrA™ in India, on behalf of MGC Pharma.
MGC Pharma has secured this import license from CDSCO for CimetrA™ to enable it to submit final samples of CimetrA™ for testing and analysis. If the tests are successful, the temporary import approval will be converted to a permanent approval once CimetrA™ has been registered as a medicine in India under the Emergency Use Authorisation Protocols. The process is expected to take 90 days from the import of the CimetrA™ samples into India.
To meet the potential significant increase in demand for CimetrATM as the result of Emergency Use Authorisation in India, MGC has secured agreements with two additional EU GMP certified production facilities which can be used to manufacture large commercial quantities of CimetrATM until the Company’s Malta production facility completes its commissioning and is fully operational in 2022.
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: “We are pleased to have secured a license to import CimetrA™ as an Emergency Use Drug in India, and hope that we can secure approval swiftly to expand its availability to a much wider patient base.
“India has been acutely affected by the COVID-19 pandemic and we believe that CimetrA™ can make an important difference in treating the symptoms of COVID-19 and alleviate patient suffering. It is important that we have secured Medopharm, as the importer and the marketing authorisation holder of CimetrA™ given their vast experience of taking medicinal products through the process to full approval for sale.”
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