STE Pharmaceuticals obtains the EU-MDR Certificate

STE Pharmaceuticals obtains the EU-MDR Certificate

STE Pharmaceuticals obtains the EU-MDR Certificate

STE Pharmaceuticals is one of the first companies to obtain EU-MDR CERTIFICATE

Medical Devices in EU are currently governed by the Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices (Medical Device Regulation, or “MDR”) from May 26th, 2021. New medical devices developments should already be focused at complying with the MDR requirements.

The medical devices’s manufacturers have a transition period until May 26, 2024 to certify all those devices that are currently certified by the previous Directive 93/42/CEE or MDD, called Medical Device Legacy.

STE Pharmaceuticals obtained at the end of 2020 the first certification under MDR in Europe for cough syrups devices and currently has more than 20 references certified under MDR, being a pioneer company in this regard.

STE Pharmaceuticals currently has the following categories of medical devices certified under MDR:

In 2020

Medical devices in liquid form for the treatment of cough: a complete range of cough syrups based on cane sugar, gums and natural plant extracts, suitable for adults and children from 1 year.

In 2020

Sprays solution for nasal irrigation: nasal sprays based on sea water and purified water with different salts concentrations, formats and spray strengths, indicated for daily cleaning and nasal decongestion, to cover all the user’s needs from birth.

In 2020

Nasal sprays based on sea water and purified waterwith natural plant extracts, indicated for nasal decongestion. Plant extracts aid and prolong the moisturizing power of sea water and provide a pleasant and fresh aroma.

In 2020

Nasal sprays based on saline solution with propolisand natural plant extracts, indicated in pathological processes as rhinitis, excessive secretions, flu and catarrhal processes.

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    Expansion of the pharmalink’s production area

    Expansion of the pharmalink’s production area

    Expansion of the STE Pharmaceuticals’ production area

    After the new expansion of the factory, the STE Pharmaceuticals’ production plant located in Vilabella (Tarragona) now covers an area of 12,500 m2.

    The new 2,500m2 built have allowed the relocation of the production, planning, quality management and purchasing offices; as well as the increase the productive capacity of Food Supplements solid forms.

    With the expansion it has also been possible to reorganize the production lines in order to separate the Food Supplements production areas from those of Medical Devices. This gain of space in the production lines will allow the automation at some points and, in consequence, increase productivity.

    A part of the investment made has been used to enlarge the area of weight control and raw material preparation. It also let us construct a new laboratory to boost the analysis of the final product control of and microbiology.

    Vitamin D deficiency is associated with increased COVID-19 severity and mortality

    Vitamin D deficiency is associated with increased COVID-19 severity and mortality

    Vitamin D deficiency is associated with increased COVID-19 severity and mortality

    Optimal vitamin D levels help in reducing the susceptibility to respiratory infections and might be useful for the treatment of people who become infected with COVID-19.

    Vitamin D is important for bone health, but it also has a role as an essential immunologic mediator having inhibitory effects on the production of pro-inflammatory cytokines, including TNF-alpha and IL-6. Therefore, low vitamin D status has been associated with a range of autoimmune, cardiovascular, and infectious diseases like influenza and respiratory viruses, including COVID-19 infection1.

    Vitamin D can be produced in the skin through exposure to sunlight and, a person can also boost their vitamin D intake through certain foods or by taking vitamin D supplements. Vitamin D supplementation helps in reducing the susceptibility of developing flu by acting as a physical barrier against the infection, or through modulation of natural and/or adaptive immunity mechanisms to reduce the risk of infection. Vitamin D supplementation might be also useful to increase vitamin D levels for the treatment of people who become infected with COVID-192.

    Vitamin D deficiency pre-COVID-19 infection increases disease severity and mortality risk

    A retrospective study has demonstrated a correlation between deficiency of vitamin D before COVID-19 infection and increased COVID-19 severity and mortality during hospitalization. The study led by Amiel A. Dror, for the Department of Otolaryngology, Head and Neck Surgery of the Galilee Medical Center (Nahariya, Israel) examined the relationship between pre-infection serum level of 25-hydroxyvitamin D (25(OH)D) and disease severity and mortality due to SARS-CoV-23.

    The authors evaluated 253 medical records of individuals with positive polymerase chain reaction (PCR) tests for SARS-CoV-2 and records of a 25(OH)D level before COVID-19 infection.

    Vitamin D deficiency was associated with both severity and mortality of COVID-19 disease. Based on vitamin D levels prior to COVID-19 infection, patients with vitamin D deficiency (<20 ng/mL) were 14 times more likely to have severe or critical disease than patients with 25(OH)D ≥ 40 ng/mL (OR 14; 95% CI 4 to 51; p < 0.001).

    Vitamin D supplementation

    Having adequate vitamin D levels helps improve general immunity and prevent some immune disorders. Daily vitamin D supplementation has been proven effective to increase vitamin D levels and reach the optimal level of 40-60 mg/mL.

    STE Pharmaceuticals offers a range of vitamin D3 supplement products, for vitamin D deficiency or as a dietary supplement:

    Vitalynk D3 oral spray, Vitalynk D3 forte oral spray and Vitalynk D3 drops, food supplements based on vitamin D, which contributes to the normal function of the immune system and the maintenance of normal bones and muscle function.

    Vitalynk D3+K2 drops, food supplement based on vitamin D and vitamin K. Vitamin K contributes to the maintenance of normal bones and normal blood clotting.

    Both spray and drops are practical and innovative presentations that enable to reach the optimal level of vitamin D.

    Reference

    1. Charoenngam N, Holick MF. Immunologic effects of vitamin d on human health and disease. Nutrients. 2020;12(7):2097
    2. Grant WB, Lahore H, McDonnell SL, et al. Evidence that vitamin D supplementation could reduce risk of influenza and COVID-19 infections and deaths. Nutrients. 2020; 12(4):988
    3. Dror AA, Morozov N, Daoud A, et al. Pre-infection 25-hydroxyvitamin D3 levels and assciation with severity of COVID-19 illness. PLoS ONE. 2022;17(2):e0263069