Lactulose Oral Solution Suppliers & Bulk Manufacturers

Available Forms: Oral solution

Available Strengths: 10 g/15 mL

Reference Brands: Enulose(US)

Category: Gastrointestinal Drugs

Lactulose oral solution is available in Oral solution and strengths such as 10 g/15 mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Lactulose oral solution is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Lactulose oral solution can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description: Lactulose oral solution, marketed as Duphalac and Enulose, is approved in the US by the FDA and in the EU via EMA for constipation and hepatic encephalopathy. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data, while EMA ensures compliance with regional safety and manufacturing requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and worldwide availability of lactulose oral solutions, enhancing gastrointestinal and liver health management across diverse patient populations globally.