UK MHRA gives marketing authorisation for Cisplatin

This year, the company intends to increase its sales in the UK to approximately two million Euros

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MHRA UK FDA
MHRA UK

Last Updated on January 3, 2024 by The Health Master

Venus Remedies has secured marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Cisplatin, a chemotherapy drug used as a first-line treatment for advanced ovarian cancer, testicular cancer and bladder carcinoma.

UK MHRA: The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

This marketing authorisation granted to Venus Pharma, the German subsidiary of Venus Remedies, will enable the company to offer its cancer drugs to the National Health Service (NHS) in the UK and neighbouring countries.

A company release informed that the registration for Cisplatin will also expedite the process of registering the oncology products of Venus Remedies in many other countries around the world which consider the UK as a reference country for fast-tracking registration and open opportunities for supplying unregistered products to several markets globally.

Saransh Chaudhary, President, Global Critical Care, Venus Remedies said, “This year, the company intends to increase its sales in the UK to approximately two million Euros. We plan to achieve this by focusing on seven molecules which are already registered in the UK and augmenting their sales by 20 per cent on a year-on-year basis. We are also planning to add new molecules in the UK and other European countries, which will help us expand our operations and improve our sales in these markets.”

Venus Remedies has received many marketing authorisations from the UK MHRA for several drugs, including:

  • Gemcitabine,
  • Bortezomib,
  • Meropenem,
  • Docetaxel,
  • Carboplatin,
  • Ceftazidime.

“Obtaining marketing authorisations for our drugs in the UK will also help us strengthen our position in regulated markets in the Middle East, Latin America and other markets in Europe. Having product registrations from a recognised regulatory agency like the UK MHRA lends us a lot of credibility and enables us to streamline the registration process in other markets,” said Chaudhary.

He said the registration for Cisplatin in the UK would potentially help Venus Remedies in expediting the registration of its oncology product Paclitaxel, which is pending with the MHRA. “We are also about to apply for the marketing authorisation for Bendamustin, a chemotherapy medication used in the treatment of chronic lymphocytic leukaemia, in the UK,” he added.

The registration process for each drug is evaluated on a case-by-case basis, which differs from country to country, taking into account factors like safety, efficacy and quality.

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