BIOFAC A/S

Lactulose

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

Danipharm Lactulose Liquid API

Danipharm Lactulose Liquid API complies with both EP and USP. Lactulose is manufactured at Danipharm A/S in Denmark - a subsidiary company, 100 % owned by BIOFAC. Our standard bulk packaging is 280 kg plastic drums or 1330 kg pallet containers (IBCs).

When stored in our bulk packaging of either 280 kg drums or 1330 kg pallet containers, Lactulose has a shelf life of minimum 3 years.

Lactulose Liquid OEM finished products

BIOFAC offers a contract manufacturing of Lactulose Liquid finished dosage forms at our modern factory Pharmadan A/S in Denmark. We offer packaging in bottles of various sizes from 100 ml to 1000 ml and in single dose sachets of 10 g/15 ml. 

Storage and stability

The stability of Lactulose is best protected when stored in tightly closed containers protected from light at temperatures between 5 - 25°C.  The stability varies depending on the type of packing.  When stored in our bulk packing of either 280 kg drums or 1330 kg pallet containers our Lactulose has a shelf life of minimum 3 years. 

Regulatory Compliance

  • GMP certificate by Danish Health and Medicines Authorities.

Danipharm has also 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

Areas of application:

Lactulose is a gentle yet effective laxative

Lactulose is a well-known laxative with more than 40 years' long safety record. The lactulose is appreciated for its gentle and natural yet effective way of action, comprising prebiotic, osmotic and peristalsis-activating properties.

Lactulose is practically not absorbed by the digestive system and has a positive effect on the bacterial flora of the intestines. There are no major known side effects from using Lactulose.

Lactulose in treatment of portal-systemic encephalopathy

Due to its detoxifying properties, Lactulose is useful in treatment of the hyperammonemia caused by portal-systemic encephalopathy (PSE). The increased biomasses inhibit the formation of blood ammonia. Lactulose promotes the diffusion of ammonia from the blood into the intestinal lumen and an eventual excretion from the body with the stool.

Lactulose as a food and feed ingredient

Lactulose is also a food and feed ingredient offering beneficial health benefits on digestive health. Lactulose is recognized by its digestive qualities by EFSA (European Food Safety Authorities) and MFDS (Ministry of Food and Drug Safety of Korea). It works as a prebiotic within the colonic microflora, increasing a number of bifidobacteria and optimizing a function of the intestinal tract by regulating intestinal transit.