SAUDI ARABIA – The Saudi Food and Drug Authority (SFDA) has awarded Venus Remedies Limited, an India-based research pharmaceutical company, with a good manufacturing practices (GMP) certification for its unit in Baddi, Himachal Pradesh, India.
Venus Remedies has also received marketing authorisations for its generic cancer drugs from Uzbekistan and Palestine that will benefit thousands of patients as well as the broader healthcare community.
The Saudi GMP approval of Venus Remedies’ production facilities at its unit in Baddi marks an important milestone within its global manufacturing network as a trusted provider of high-quality pharmaceutical products.
In a press release, the pharmaceutical company said: “With this certification, the number of international GMP certifications for Venus Remedies has gone up to 20.”
The SFDA authorities conducted an extensive review and audit of the company’s facilities in Baddi before granting the GMP certification for its Baddi-based unit.
“In terms of products, this GMP certification for three more facilities applies to small-volume injectables, dry-powder vials, liquid vials and ampoules, and lyophilised vials,” the company confirmed to the clients.
The regulatory approval from the SFDA will enable the Indian-based company to significantly expand its manufacturing capacity at its production facilities situated at its unit in Baddi.
In addition, the Saudi GMP certification will enable Venus Remedies to expand operations to different regions thus strengthening its ability to meet the needs of patients across the Saudi Arabian market and beyond.
“The Saudi Arabian market happens to be the largest in the Gulf Cooperation Council region and the Kingdom is the leading country in the entire Gulf region in terms of quality benchmarks,” stated Venus Remedies.
The SFDA approval will encourage dialogues with regulatory authorities in the Gulf Cooperation Council (GCC) and Middle East and North Africa (MENA) regions, ultimately paving the way for marketing authorisations from other regulatory agencies.
“Venus Remedies has a fully automated robotic PFS (Prefilled Syringe) machine that ensures optimum quality. We are one of the world’s top 10 fixed-dosage injectable manufacturers,” the company outlined.
The pharma company reaffirmed to the clients that its state-of-the-art injectable facility at Baddi is designed to the highest quality standards and adheres to international regulations with advanced technology and equipment.
On his part, Akshansh Chaudhary, Executive Director of Venus Remedies, said: “This accreditation is a major milestone for us and it will help us to further expand our operations, reach new markets and strengthen our reputation.”
He stated the pharmaceutical company will continue to invest in its production facilities and processes to ensure that Venus Remedies provides the best possible care to patients worldwide
“We are committed to making a positive impact on global health. Venus Remedies is well-positioned to build a high-value portfolio of soon-to-be off-patent products in the GCC region as a result of these additional approvals,” added Chaudhary.
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