Glenmark harmaceuticals on Thursday said it has received marketing approval for its fixed-dose combination nasal spray, Ryaltris, in 13 countries across the EU and the UK.

The company is set to launch Ryaltris directly in the markets of Czech Republic, Slovakia, Poland, and the UK, Glenmark Pharmaceuticals said in a statement.

The nasal spray, which is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age, will be marketed in the rest of Europe by the Menarini Group as part of its exclusive licensing agreement with Glenmark, it added.

Glenmark Pharmaceuticals Chief Commercial Officer Robert Crockart said, “This marketing approval will pave the way for effective and timely treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other regions where Ryaltris has been launched, and we hope to extend this relief to more people across the world.”

Allergic rhinitis is both widespread and underreported, making it challenging to diagnose and treat in time. It impacts a person’s quality of life and can lead to functional impairments, while also increasing the risk of asthma, he added.

The company said Ryaltris relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes.

Glenmark said Ryaltris has been well received by the global medical community for the effective treatment of seasonal and perennial allergic rhinitis. Over 4,000 patients globally took part in Ryaltris clinical trials initiated in 2014.

In April this year, Glenmark concluded the decentralised regulatory procedure in Europe, enabling approval in 17 countries across the EU and the UK.

Glenmark further said it has also partnered with Hikma Pharmaceuticals and Bausch Health for the commercialisation of Ryaltris in the US and Canada, respectively. Currently, it is under review with the US Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the US.

The homegrown pharma major said during FY21-22, it has also received regulatory approval for Ryaltris in the Philippines, Zambia, Ecuador and Peru.

Sales of the nasal spray continue to progress well in Australia, South Africa, Ukraine and Uzbekistan, it said adding the company has also initiated the commercial launch in Russia in Q1, FY21-22.

“The company is awaiting regulatory approvals for its filings in various markets across Canada, Brazil, Malaysia, Saudi Arabia and several other emerging markets,” the statement said.

In China, Glenmark said its partner, Grand Pharmaceutical (China), has finalised the Phase 3 protocol for the country and submitted application in July 2021, while in South Korea, the company is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22. Also, the company is working to submit the application for paediatric efficacy supplement in the country.

According to Market Research Future (MRFR), the Kaolin Market is predicted to develop at a 4.1% CAGR through the forecast period. Kaolin was created nearly 150 million years ago. Its chief constituent is kaolinite, a hydrous aluminum silicate formed by the decomposition of minerals and silicates such as mica, quartz, feldspar, or metallic oxides such as rutile and hematite. It has found increased demand in treating a range of ailments in ancient times and even now for diarrhea, swelling, and sores inside the mouth to stop blood loss and other conditions. Still, there is no relevant scientific evidence to support most of these usages. Kaolin, or China clay, is virtually white, and it is differentiated from other industrial clays based on its fine particle dimensions and pure coloring.  Its capability to dissolve in water presents it as an ideal pigment. In the 7th and 8th centuries, the Chinese were the forerunners to use kaolin to make porcelain. Although kaolin is found worldwide, deposits with suitable viscosity, whiteness, and other favorable characteristics are rare.  The United States region has some high-quality deposits in its Southeastern regions.  The mineral has been mined from colonial times in the states of South Carolina and Georgia. Brazil and the United Kingdom are the Other valuable kaolin deposits globally.

COVID-19 Impact:

The COVID-19 occurrence had disturbed the manufacturing and supply in the kaolin market and delayed the global industry’s development. Many businesses in the kaolinite market are utilizing strategies to reduce downtime losses that are becoming worrying as the effects of the pandemic linger. The well-known factor propelling the global kaolin market’s development is the swelling demand for kaolin in the paper industry; despite most of the applications not requiring paper as much as before, the formal correspondence is conducted on paper, even now leaving an enormous potential for kaolin in the paper industry. Kaolin is extensively implemented in high-grade ceramics manufacture, which is further used to design whitewares, such as sanitaryware, tableware, and tiles. These applications are estimated to see an increased demand in the coming years, which will benefit the kaolin market.

Market Segmentation:

Furthermore, developing new application areas such as cosmetics and pharmaceuticals on a larger scale will likely propel the future market’s progress. Potential substitutes’ availability is expected to hamper the global kaolin market’s growth. In terms of value, the calcined segment led the global kaolin market with a 50.2% share in 2019 and is likely to list a 4% CAGR throughout the review period. The paper segment described the leading share of above 35% in 2018 due to kaolin’s extraordinary properties such as whiteness, ink absorptivity, printing characteristics, and glossiness. This is evident in MAJUPERAK Holdings Bhd, a Perak-based property developer’s appointment of Modkha Marine Sdn Bhd as the operative for its kaolin mining outfit in the state. Majuperak, through its wholly-owned subsidiary, Majuperak Energy Resources Sdn Bhd, participated in a mining operations contract with Modkha Marine, which allows the latter to obtain raw kaolin from the site for cash trades of RM13.50 per tonne.

Regional Market Insights:

The Asia Pacific kaolin demand managed the kaolin market in 2018 to 2020. The National markets of India, China, and Japan see budding demand for kaolin from several industrial verticals due to the quick industrialization degree and budding per-capita income in these nations. The regional market is anticipated to record a CAGR of over 4.5% throughout the forecast period. Suvo Strategic Minerals (SUV), a notable player in the APAC region, has announced its latest trimestral earning. The company ended the year well-funded with $7.4 million in reserve. It was a big quarter for the kaolin and silica sand manufacturer, who also attained Imerys’ hydrous kaolin operations centered in Australia SUV effectively procured $6 million in an oversubscribed assignment to fund the charge of buying the new operation. The European kaolin market held the second prime market share globally in 2018. The kaolin market in Europe was evaluated to be assessed at USD 1,295.0 million in 2018. Germany influenced the regional market’s main share and is projected to log the uppermost CAGR in the review period.