Danipharm A/S

In 1988 the BIOFAC group of companies acquired a chemical factory in Northern Jutland. A lot of new equipment and machinery was installed and in August 1989 Danipharm A/S started the production of Lactulose Concentrate. Since then the factory has been modernized, enlarged, and automated and the capacity of production has been increased considerably.

Today Danipharm A/S is a completely modern, effective and well-functioning production unit inspected and approved by the US FDA as well as by the Danish Health Authorities. Danipharm A/S produces Lactulose in bulk form (API according to GMP Q7A).

Regulatory Compliance:

• Danipharm A/S holds a GMP certificate by Danish Health and Medicines Authorities
• Danipharm A/S holds a Manufacturer’s Authorisation regarding Human Medicinal Products by Danish Health and Medicines Authorities
• Danipharm A/S is registered as a Manufacturer of Active Substance used in Medicinal Products for Human Use, as defined in the Medicines Act section 50a (1) implementing the Directive 2011/62/EU of 8 June 2011
• Certificate of Suitability (CEP) by EDQM is available for API Lactulose
• Danish Environmental Protection Agency (Danish EPA) has made a categorization of BIOFAC group as to an instruction No. 6 of 2004 on Differential Environmental Review and assessed that the company is placed in Category 1 (the best category) because of the high level of systematism and high level of regulatory compliance
• Danish Working Environment Authority has given BIOFAC group a Green Smiley, indicating that the company has no issues with the Working Environment Authority, providing a high level of health and safety.