Measured approach: India’s Pulsepharma sets sights on international expansion with nano vitamin D3
Its nano vitamin D3, branded Deksel, has been sold in India for the past six years, as well as in certain parts of South East Asia and Africa. It now plans to bring the products into new markets, including the US and Europe.
The Deksel line of vitamin D3 is made with an encapsulation technology which allows the fat-soluble vitamin D3 to be stored into a lipid carrier.
According to MD Raam Babu, the technology, which the company had spent four years developing, makes vitamin D3 50% to 60% more bioavailable than the conventional formulations.
“Usually, you will need to mix vitamin D3 in creamy milk or take it after food. Then, some fat components from the food will be converted to fatty monomers which are arranged into mixed micelles in which the vitamin D3 molecule is entrapped in.
“But this process is a chance phenomenon. Not the entire vitamin D3 will get entrapped,” he said, adding that the nano lipid carrier also makes the product more stable and thus, allows for a longer shelf-life at 24 months. Many vitamin D3 products have a shelf-life of about 18 months, he added.
The company now plans to export the vitamin D3 product to 25 markets, including more South East Asian countries, US, Europe, Africa, Latin America, and Russia over the next year.
It currently exports to markets such as Dubai, Kenya, and Malaysia.
The company has already received a patent in India, Australia, Mexico, and the patent applications are in the final stages in Russia, Europe, and the US.
The Deksel vitamin D3 is available in 1,000 IU and 2,000 IU sprays for daily maintenance, 400 IU vitamin D3 drops for paediatric use, and higher dosage at 50,000 IU and 60,000 IU in the form of 5ml shots.
The company recently partnered Nutrify India – an idea-to-commercialisation platform that connects business and facilitates knowledge sharing – in expanding its business into the US.
As part of its plans in entering the US markets, as well as Australia and Europe which have more stringent production requirements, the company is now starting to build a USFDA and Australian Therapeutic Goods Administration (TGA) approved facility.
Based in Hyderabad, the company will invest USD$10m into the 250,000 square metre site, which will be used to produce vitamin D3 and the company’s new range of pharma and nutra products.
The company currently engages a contract manufacturer which has gained the TGA accreditation to produce its vitamin D3.
Babu is also open to the possibility of conducting a technology transfer and manufacturing the products in the US.
“In the US, we will probably find a partner where we will do technology transfer and do local manufacturing and we can market, launch it in our brand, or we can have some co-ownership of the brand. We are open to discuss this kind of partnerships,” he said.
In these markets, the company plans to sell the nano vitamin D3 as dietary supplements for the low dose vitamin D3 and via the prescription route for the high dose vitamin D3.
This is different from the domestic market India, where the products are sold as prescription products.
The company is currently conducting a clinical trial on COVID-19 patients in India with its nano vitamin D3.
The aim is to prevent the symptoms from worsening in these patients.
The trial conducted in Hyderabad intends to recruit 100 patients, where patients will be given high dose of nano vitamin D3 (60,000 IU) in 10 days.
Babu said that the trial would conclude in the next month.
The company had also conducted clinical trials using vitamin D on patients with mechanical low back ache.
Subjects were given“Deksel nano vitamin D and vitamin D in other forms such as granules and softgel capsules.
It was found that subjects taking “Deksel” had significant improvement in their serum vitamin D levels, increasing from 17ng/ml to 97ng/ml, while that of the other two groups increased from 15ng/ml to 69ng/ml and 67ng/ml respectively.
In addition, the group taking Deksel saw a relief of mechanical low back pain, with visual analogue scale (VAS) score improved from 7 to 2, while no significant improvements were seen in the other two groups.