BIOFAC A/S

Biofac A/S Kastrup

In 2005, Biofac decided to move the existing production facilities for Thrombin to a newly completely modernized building in Kastrup. Here Biofac, Kastrup was established producing the pharmaceutical enzymes Thrombin and Fibrinolysin. Both these completely new production lines are now GMP approved by the Danish FDA ("L√¶gemiddelstyrelsen") according to Q7A.

 

Regulatory Compliance:

  • Biofac A/S in Kastrup  holds a GMP certificate by Danish Health and Medicines Authorities.

 

  • Biofac A/S in Kastrup holds a Manufacturing licence for derived products from category 3 materials in accordance with article 18 of the Bio-product statutory.

 

  • Biofac A/S in Kastrup holds a Manufacturer's Authorisation regarding Human Medicinal Products for manufacturing biological active starting materials by Danish Health and Medicines Authorities.

 

  • 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 thatthe company has no issues with the Working Environment Authority, providing a high level of health and safety.

 

GMP Sundhedsstyrelsen Danish Minsitry of Enviroment Arbejdstilsynet

 


Products

Plasmin

[PDF]

Thrombin

[PDF]