Lactulose oral solution bulk supplier for pharma manufacturers

Lactulose Oral Solution 10 g/15 mL Suppliers & Bulk Manufacturers

Available Forms: Oral solution

Available Strengths: 10 g/15 mL

Reference Brands: Enulose(US)

Lactulose oral solution is an osmotic laxative that draws water into the colon, softening stool and promoting bowel movements. It reduces ammonia levels in liver disease, supports detoxification, and relieves constipation. Benefits include improved bowel regularity, reduced hepatic encephalopathy risk, and enhanced digestive and liver health.

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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.

Lactulose Oral Solution — third party manufacturing & bulk supply

Lactulose Oral Solution 10 g/15 mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Lactulose Oral Solution is supplied as Oral solution — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Lactulose Oral Solution listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Lactulose oral solution is listed as Oral solution in 10 g/15 mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Lactulose oral solution is referenced against Enulose(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.