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Frequently Asked Questions
Pharmgenity Health supplies a comprehensive range of vitamin and mineral APIs including iron supplements (Ferric Ammonium Citrate, Ferrous Ascorbate DC Grade), calcium salts (Calcium Aspartate, Calcium Citrate, Calcium Citrate Malate, Calcium Orotate), magnesium salts (Magnesium Citrate, Magnesium Gluconate), zinc compounds (Zinc Gluconate, Zinc Oxide, Zinc Sulfate Mono and Hepta), manganese supplements (Manganese Gluconate), amino acids (L-Lysine Hydrochloride), and a wide range of vitamins (A, B1, B6, B12, C, D3, E, K, Biotin, Folic Acid, Niacinamide) and specialty nutrients (Lutein, Lycopene, Astaxanthin, Glucosamine, Omega-3 fatty acids).
Different iron supplement APIs offer varying levels of bioavailability and tolerability. Ferrous Ascorbate (DC Grade) combines iron with vitamin C (ascorbate), which enhances iron absorption while providing a directly compressible grade suitable for tablet manufacturing. Ferric Ammonium Citrate is a trivalent iron form that is gentler on the stomach but has lower bioavailability compared to ferrous forms. For maximum bioavailability, ferrous salts like ferrous fumarate and ferrous gluconate are preferred, though they may cause more gastrointestinal side effects. The choice depends on the target patient population and formulation requirements.
For nutritional supplement APIs, critical quality specifications include assay potency within labeled claims, heavy metals content (particularly lead, arsenic, cadmium, and mercury which are closely regulated in supplements), microbial limits per USP <2021> and <2022>, residual solvent profiles, particle size distribution for blending and tableting performance, and stability under accelerated and long-term conditions. For vitamins, we also monitor for degradation products and potency loss over shelf life. All our nutritional APIs meet applicable USP, FCC, or EP standards.
Yes, we supply several nutritional APIs in directly compressible (DC) grades specifically designed for tablet manufacturing. Ferrous Ascorbate DC Grade is engineered with optimized particle size, flow properties, and compressibility for direct compression into tablets without wet granulation. We also supply DC grades of various vitamins and minerals that can be directly blended with excipients and compressed, reducing manufacturing complexity and cost. These DC grades maintain content uniformity and provide consistent tablet hardness and disintegration profiles.
For nutritional supplement ingredients, we provide comprehensive documentation including certificates of analysis with full specification testing, material safety data sheets (MSDS), GMP certificates, flowcharts of manufacturing processes, stability data supporting retest periods, non-GMO and allergen statements where applicable, BSE/TSE-free certificates, kosher and halal certification where available, heavy metals and microbial test reports, and technical data sheets with physicochemical properties. We can also provide regulatory dossiers to support product registrations in various global markets.