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diosmectite Sachets 3 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Vietnam
GMP approvals
EU GMP, PICS, Japan
Manufacturer #20843

This CTD dossier owner and manufacturer in Southeast Asia is actively supporting healthcare and education through numerous initiatives. They have donated their innovative Bioskin hand sanitizer, featuring antibacterial Nano Silver and natural oils, to teachers and staff in education sectors, and frontline workers across the region. Their contributions include nearly 10 billion VND in support, encompassing essential medical supplies, equipment, and monetary donations for epidemic prevention. With a focus on community well-being, they continue to provide widespread access to Bioskin in over 10,000 pharmacies, enhancing public health during challenging times.

Diosmectite

Diosmectite is a natural silicate of Aluminum & Magnesium. It is used as an intestinal adsorbent in the treatment of several diseases affecting the gastrointestinal tract, including infectious and non-infectious acute and chronic diarrhoea. It is also used in the treatment of irritable bowel syndrome diarrhea subtype. Other uses of Diosmectite include chronic diarrhea caused by radiation or chemotherapy-induced, and AIDS-associated chronic diarrhea. Diosmectite is sold under the brand names Smecta & Smecdral to name a few. Ipsen Pharma SAS owns the current patent of this medicine, the USFDA granted the approval for sales in 2015 in the USA, it is marketed by many companies on behalf of Ipsen Pharma.

Forms and Dosage:

Diosmectite is insoluble in water. Diosmectite’s adjuvant to rehydration therapy for acute infectious diarrhoea in children reduces the duration of Diarrhoea by a full day and it may increase cure rate by the third day. Not only does it reduce stool output, but it also has no effect on hospitalization rates or need for intravenous therapy. In the treatment of acute diarrhea in infants and children up to 1 year, the recommended dose is 2 packets a day for 3 days, followed by 1 packet a day. For kids older than 1 year and older, the recommended dose is 4 packets a day for 3 days, followed by 2 packets a day. Whereas in adults, the standard dose on average is 3 packets a day. Doctors can double the dose as per the need.

The cost of Diosmectite

In Malaysia, the consumers pay 100 ringitt for a supply for 10 sachets of the oral solution. Whereas the 3mg product sells for 33USD in France. In India, the 30 ml syrup manufactured by a generic formulation costs 0.06 USD.

How does it work?

Diosmectite does not get absorbed in the intestine but it can adsorb eight times its own weight of water, thereby diminishing free stool water. Diosmectite can also adsorbs toxins, bacteria, and rotavirus, preventing adherence to intestinal membranes. Diosmectite is effective in improving stool consistency because of its ability to absorb bacteria, viruses and toxins as well as strengthening the intestinal mucus barrier to reduce luminal antigens passing through the mucus barrier which in turn helps to reduce inflammation. Efficacy findings on Diosmectite indicate that it exerts an anti-diarrhoeal effect by inhibiting viral replication and the expression of NSP4.

Finding Diosmesctite Manufacturers and Diosmesctite Suppliers

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