Oct 31,2019

Investing in the future of anhydrous lactose

The  Direct  Compression  process  is  becoming  more  popular  in  the  Pharmaceutical  industry  for producing tablets, due to overall cost effectiveness. Anhydrous lactose is especially beneficial in direct compression due to its superior compactibility. Along with a growing pharmaceutical market and a shift towards DC, the global demand   of anhydrous lactose will further increase. DFE Pharma will be prepared  and  be  able  to  grow  along  with  our  customer’s  excipient  needs.  This  to  ensure  long  term partnerships and therewith ensure supply of high quality anhydrous lactose grades.

Growth of Anhydrous lactose

The Direct Compression process is becoming more popular in the Pharmaceutical industry for producing tablets, due to overall cost effectiveness. Anhydrous lactose is especially beneficial in direct compression due to its superior compactibility. Along with a growing pharmaceutical market and a shift towards DC, the global demand of anhydrous lactose will further increase. DFE Pharma will be prepared and be able to grow along with our customer’s excipient needs. This to ensure long term partnerships and therewith ensure supply of high quality anhydrous lactose grades.

New production line for anhydrous lactose

Anhydrous lactose is produced in our dedicated pharmaceutical plant in Nörten-Hardenberg, Germany. Within this production location an investment in the future has taken place by implementing a new production line for anhydrous lactose. We are proud to announce that this new production line will be operational in December 2019.
We are aware that it takes time before products from the new line can be utilized within your company. Therefore, in case there are any questions, please feel free to reach out to your DFE Pharma contact person so we can help and support you with a smooth qualification process.

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FAQ

1: Will the anhydrous lactose grades, produced on the new line, be manufactured and released to the same standards as the current anhydrous products?

Yes, products produced on the new production line will follow the same process steps as the existing production line. This is strengthened by the fact   similar equipment is used as well as the same raw materials and packaging is used. Furthermore, products produced from the new line will be released according to the same specification as products from the existing production line. Therefore, you can be assured that the same high quality products will be supplied to you.

Supporting documents: PD-0223

 

2: How will I be sure that only product from the existing ( or new) line is supplied to my company? Can I only receive the new material upon request?

Yes, DFE Pharma has created new article codes for products produced on the new line. As a customer you can decide to receive product from the existing line or new line.

 

3: Is it a site change ?

The new production line is situated in a new building which is connected to the existing manufacturing site at Nörten-Hardenberg, Germany. The new line will therefore be:

  • At the same location being manufacturing site Nörten-Hardenberg
  • in a new building connected to the existing production site
  • in a separate medium care room.  

 

4: Are the products from the new production line equivalent ( in functionality) to the existing products ?

The  verification  of  the  equivalency  of  the  products  produced  on  the  new  line,  with  the  products produced  on  the  existing  anhydrous  lactose  manufacturing  line,  is  an  integral  part  of  the  process validation study. 

The  acceptance  criteria  of  these  test  functions  have  been  set  based  on  existing  QC  data  over  the observation  manufacturing  period  2014-2019.  Data  have  been  statistically  analyzed  and  tolerance ranges for the product equivalency studies have been set based on historical variation observed in this period,  in  order  to  match  the  product  of  the  new  line  with  the  current  products.  Documentation showing product equivalency data will be available upon request.

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