Pharmacopoeia and Regulatory Information

Neusilin is manufactured under strict quality control at our FDA-GMP certified facilities Neusilin® meets all the requirements of the current USP/NF, and EP specifications. An US DMF type IV filed in 1998.

Dosage and Safety

Neusilin^® is safe with no reports of adverse reactions and is an accepted ingredient by the US Pharmacopoeia/National Formulary and Japanese Pharmaceutical Codex. Based on the usage as an excipient in various formulations in Japan, Neusilin^® up to 1.05 g can be used for oral uptake per day.^*1 Neusilin^® (Alkaline grades) is also approved as antacid active ingredient where the maximum dosage is 4g / day.^*2 There are no established maximum oral intake limits specified by US-FDA.

Stability

Neusilin^® is a stable inorganic compound and meets JP, USP/NF, and EP specifications.