Member Article

Durham's Quantum Pharma gets approval for four new Vitamin D products

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Colonis Pharma Limited, the product development arm of Durham-based pharmaceutical manufacturer Quantum Pharma Plc, product licenses for two new strengths of Vitamin D capsules.

Colonis develops the group’s pharmaceuticals division which takes niche pharmaceutical products, including Specials, through the regulatory pathway to achieve marketing authorisation.

The two new strengths, 800 IU capsules and 1000 IU capsules, are in both branded and generic versions, giving a total of four new licensed products.

The 1000 IU capsule represents the first unlicensed to licensed development of its type to be made available in the UK and will be launched by way of ‘cease and desist’ notices, which will mean equivalent unlicensed medicines will no longer be able to be supplied.

Vitamin D is essential for skeletal growth and bone health and severe deficiency can result in rickets among children and osteomalacia among children and adults.

There is a wide range of uses for Vitamin D and recent research has found that lower levels of Vitamin D have also been linked with a higher risk of cancer.

Quantum is building a branded product range that services this fast growing area of treatment. Currently the NHS prescribes the equivalent of 1.2 million 30 capsule packs of 800 IU per annum met by licensed pharmaceuticals and nutritionals and 160,000 30 capsule packs of 1000 IU per annum fulfilled by specials and nutritionals.

As a result of government health guidelines, there is increasing use of Vitamin D supplements in at-risk groups, which include infants and children, pregnant and breastfeeding women, people over 65 years of age and those who have low or no exposure to sunlight.

Andrew Scaife, Chief Executive of Quantum Pharma Plc, said: “We are delighted to receive licences for these two new strengths of our Vitamin D range in both branded and generic presentations.

“Vitamin D deficiency is a growing market in which we are seeking to become a significant player through our commitment to developing a broad product range.”

“The 1000 IU strength is of particular interest as it represents the first unlicensed to licensed product development of its type to be made available in the UK and demonstrates our pipeline moving into delivery.

“The 800 IU complements and adds to our portfolio of different strengths of UK licensed Vitamin D capsules.”

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