Venus Remedies becomes the first Indian company to receive SFDA (Saudi Arabia FDA) Good Manufacturing Practices (GMP) approval for four of its injectable manufacturing facilities viz. oncology liquid, oncology lyophilized, dry powders cephalosporin and dry powder carbapenem.
Pawan Chaudhary, CMD, said, “Saudi Arabia has huge potential as vast majority of the pharmaceutical market is provided by imports and domestic production accounts for about 15 per cent of the total market. Saudi Arabia market tends to favour private pharmacy sector branded pharmaceuticals whereas the public sector is more generic lead.”.
With this GMP certification, the company expects to tap a big geography of GCC countries comprising of Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, the Sultanate of Oman, and the Republic of Yemen. Pawan Chaudhary further added that access to these GCC countries will generate a good business for the company as present Saudi pharmaceutical market is about US$ 2.7 billion which is expected to grow at a CAGR of 6.32 per cent, and is estimated to be worth US$7.6 and US$9.6 billion by 2014 and 2019 respectively of which Saudi Arabia pharmaceutical market is the richest and leads with 49 per cent of the total share.
Venus Remedies, an existing European Union Good Manufacturing Practices (EU-GMP) certified pharmaceutical company with addition of Saudi Arbia today possesses 14 GMP accreditations for its super specialty injectable manufacturing facilities conferred by various countries around the globe.
The certification has let Venus break the tough entry barriers by capturing stringent regulatory approval prevalent in these countries. Opportunities now exist for the company to explore possibilities to promote its innovative R&D patented products and the company sees tremendous potential for growth and expansion. Venus has already been granted patents for 4 of its research products from European Union, South Africa, South Korea, Ukraine, Australia, New Zealand, and many are in pipe line.
The company plans to enter Saudi Arabia and other GCC countries by way of providing and filing for product registrations CTD dossiers, a regulatory system similar to that prevalent in Europe from where the company has already obtained product marketing authorizations for some of its products.