Venus Remedies gets marketing approval from Saudi for Docetaxel

This marketing authorisation from the largest GCC market will enable Venus Remedies to establish a strong foothold in GCC and MENA regions

Venus Remedies secured a marketing authorisation from the largest market in the Gulf Cooperation Council (GCC) region for Docetaxel, a chemotherapy drug.

The development comes three months after the company received good manufacturing practices (GMP) certification from the Saudi Food and Drug Authority (SFDA) for all its production facilities at its unit in Baddi, Himachal Pradesh.

The demand for Docetaxel has been steadily increasing the world over with the rising incidence of breast, prostate, stomach and non-small cell lung cancers, for which this chemotherapy drug is used as a first line of treatment. Docetaxel-based treatment has particularly improved the survival rate among men in castration-sensitive prostate cancers. The $102-billion global Docetaxel market is projected to grow to $184 billion by year 2030 at a CAGR of 10.22 per cent.

The marketing approval for Docetaxel from Saudi Arabia, a $7.8-billion pharma market (as in 2021) signifies a major step in the global expansion strategy of Venus Remedies in the oncology space.

Saransh Chaudhary, President, Global Critical Care, Venus Remedies, said, “This approval will enable us to solidify our existing foothold in the GCC and Middle East and North Africa (MENA) regions by streamlining the registration process for our oncology drugs there, ultimately benefiting a large population in need of advanced cancer treatments.”

This approval is expected to pave the way for marketing authorisations from other countries in the GCC and MENA regions which consider SFDA as a reference authority.

Venus Remedies has, of late, been rapidly consolidating its position in the oncology space. Its German subsidiary Venus Pharma GmbH had secured a marketing authorisation from the UK for key chemotherapy drug Cisplatin only last month, thus expediting the process of registering its oncology products in many other countries which consider the UK as a reference point for fast-tracking registration. The company followed this up with marketing authorisation for two more cancer drugs from Philippines, the second largest market in the ASEAN region, and Iraq, a sizeable market in the MENA zone.

docetaxelGulf Cooperation Councilmarketing authorisationSaudi Food and Drug AuthorityVenus Remedies
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