Product Information

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 JPC. 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.

*1) Encyclopedia of Pharmaceutical Additives, Japan, 2005
*2) Japanese approved list of manufacturing and import of gastrointestinal drugs

Stability

Neusilin® is a stable inorganic compound and meets JPC and NF specifications. It is stable for 3 years from the date of manufacture.