Lactulose (GMP) Bulk & Finished prod.

BIOFAC supplies Lactulose Liquid as API in bulk in compliance with EP and USP or as OEM finished products in various packaging.


Lactulose is a well-known laxative with more than 50 years’ long safety record. It is appreciated for its gentle and natural yet effective way of action, comprising prebiotic, osmotic, and peristalsis-activating properties (1; 2). Although chiefly used for treatment of constipation, lactulose has during recent years gained interest due to its key role in multiple mechanisms directly linked to improved gut metabolism, lower risk of infection and inflammation, cognitive function, and to treatment of diabetes amongst others (2; 3).


By taking advantages of our 75 years of expertise in the pharmaceutical and nutraceutical industries, BIOFAC produces Lactulose for your research and manufacturing needs:


Lactulose as a laxative
Due to its role as a non-digestible synthetic disaccharide, Lactulose passes through to the colon largely intact. The presence of lactulose in the colon results in increased osmotic effect and intraluminal gas formation that increase stool volume and softened stool, as well as stimulate the peristaltic bowel movement and relief of constipation hereby eliciting its laxative effects (2; 3), see Fig. 1,A.

Lactulose as a prebiotic
In multiple preclinical and clinical studies, the treatment effect of lactulose results from its prebiotic effect on the gut, largely due to alteration in the colonic microbiota and formation of metabolites short-chain fatty acids (SCFAs) (2;3;4), see Fig.1,B. Lactulose stimulates growth of health promoting Bifidobacteria and Lactobacillus directly linked to improvement of the host’s health (2;3;6;7). In addition, fermentation of Lactulose by gut bacteria produces SCFAs, mainly acetate and butyrate, that stimulate gastric emptying and hormone release (e.g., GLP-1), attenuate blood glucose and insulin levels, strengthen gut barrier functions, modulate immune responses, and maintain intestinal homeostasis by lowering gut pH hereby inhibiting growth of pathogenic microbes (2;3;4).


FIG. 1:
Part A:
Laxative effect of Lactulose;
Part B:
Prebiotic effect of Lactulose.
The health implications of Lactulose as depicted in Fig.1 have shown to be significant in terms of improving gut health, preventing infection, lowering inflammation, attenuate glucose and insulin response, and for modifying risk factors linked to development of diabetes amongst others.

Storage and stability

Lactulose should be stored in tightly closed containers protected from light at temperatures between 5 – 25°C. The stability varies depending on the type of packaging. When stored in our bulk packaging of either 280 kg drums or 1330 kg pallet containers our Lactulose has a retest date of 3 years.

Regulatory Compliance

  • GMP certificate by Danish Health and Medicines Authorities.
  • Danipharm has been inspected by the US FDA on several occasions and has been approved by the US FDA for more than 15 years.
  • Certificate of Suitability (CEP) by EDQM
  • Manufacturer’s Authorisation regarding Human Medicinal Products by Danish Health and Medicines Authorities.
  • Danish Environmental Protection Agency (Danish EPA) has made a categorization of BIOFAC as to an instruction No. 6 of 2004 on Differential Environmental Review and assessed that BIOFAC is placed in Category 1 (the best category) because of the high level of regulatory compliance.
  • Danish Working Environment Authority has given BIOFAC a green Smiley, indicating that BIOFAC has no issues with the Working Environment Authority, providing a high level of health and safety.

Sources: (1) Haemmerli, U.P et al. (1969): Wrong idea, good results (the lactulose story). N Engl J Med. Vol. 21; 281 (8): 441-2. (2) Chu, N. (2022): The potential role of lactulose pharmacotherapy in the treatment and prevention of diabetes. Front Endocrinol, Vol. 13. (3) Karakan, T. et al. (2021): Low-Dose Lactulose as Prebiotic for Improved Gut Health and Enhanced Mineral Absorption. Front Nutrition. Vol. 8. (4) Pranami, D. et al. (2017): Lactulose: a prebiotic, laxative and detoxifying agent. Drugs Ther Perspect. (5) Schuster-Wolff, B.R. et al. (2010): Production and physiological action of the disaccharide lactulose. Int Dairy J. Vol. 20, 731–41. (6) Bothe, M.K. et al. (2017): Dose dependent Prebiotic Effect of Lactulose in Computer-controlled in vitro model of the human intestine. Nutrients, Vol. 9, 767. (7) Forootan, M. et al. (2018): Chronic constipation. Medicine, Vol. 97 (20). (8) Chaoran, M. et al. (2023): Bowel movement frequency, the gut microbiome, and cognitive function in women and men. Alzheimer’s Association International Conference 2023

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