Haselmeier receives medical device Master File Number for its injection pen systems

17 Mar 2020

This documentation will enable customers worldwide to leverage the D-Flex disposable pen system for their combination product development.

Haselmeier has received Master File Number MAF3202 from the US Food and Drug Administration (FDA) for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.

Haselmeier receives medical device Master File Number for its injection pen systems

Haselmeier formally submitted the MAF for D-Flex in late 2019, following productive discussions with the FDA. Pharmaceutical customers can now refer directly to the Master File Number MAF3202 when submitting their own products based on the D-Flex pen for approval, greatly simplifying and streamlining the FDA clearance process.

With this documentation in place, customers worldwide will be able to leverage the patent-registered D-Flex disposable pen system for their combination product development.

This versatile, reliable platform is configurable for several fixed doses, bridging the gap between fixed and variable-dose pens, and can support pharmaceutical customers from clinical trials through to commercial use.

In addition to the D-Flex injection system, Haselmeier also presented its D-Flex Connect system to the FDA. D-Flex Connect comprises the D-Flex pen, a smart cap and an innovative, future-proof software platform. Following positive initial conversations with the FDA, Haselmeier plans to compile the data for either 510(k) or IDE submissions by the end of 2020, with the goal of enabling its customers to deploy D-Flex Connect in clinical trials.

Related news

Gilead pencils in potential buyout of Pionyr Immunotherapeutics

Gilead pencils in potential buyout of Pionyr Immunotherapeutics

23 Jun 2020

Pionyr's "promising, novel biology" could represent a major increase in Gileads's cancer pipeline.

Read more 
CordenPharma & Moderna extend lipid supply agreement for Moderna’s coronavirus vaccine

CordenPharma & Moderna extend lipid supply agreement for Moderna’s coronavirus vaccine

23 Jun 2020

The amended manufacturing agreement, which originally specified CordenPharma facilities Switzerland, now extends to the CDMOs France and US sites.

Read more 
TraceLink announces results from FDA DSCSA Pilot Program

TraceLink announces results from FDA DSCSA Pilot Program

23 Jun 2020

Key findings demonstrate the value of network solutions to secure and digitalize the pharmaceutical supply chain.

Read more 
FDA approves new Dupixent prefilled pen

FDA approves new Dupixent prefilled pen

23 Jun 2020

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

Read more 
Piramal acquires solid oral dosage drug product facility from G&W Laboratories

Piramal acquires solid oral dosage drug product facility from G&W Laboratories

22 Jun 2020

The site can also produce liquids, creams, and ointments, further expanding the CDMO's portfolio.

Read more 
Catalent and ViralClear Pharmaceuticals partner on potential COVID-19 treatment

Catalent and ViralClear Pharmaceuticals partner on potential COVID-19 treatment

22 Jun 2020

The CDMO will work on developing a solution and a solid oral dosage form of ViralClear's merimepodib.

Read more 
Sanofi to build EUR 490 million vaccine production facility in France

Sanofi to build EUR 490 million vaccine production facility in France

16 Jun 2020

The French pharma company will also invest EUR 120 million to create a new research center at Marcy-l'Etoile dedicated to vaccines

Read more 
Pharma packaging companies commit to supply for COVID-19 fight

Pharma packaging companies commit to supply for COVID-19 fight

16 Jun 2020

Stevanato Group, SCHOTT, and Gerresheimer confirm their readiness to support future COVID-19 vaccine with pharmaceutical containers.

Read more 
BIA Separations introduces PrimaS multi-mode ligand bioprocessing technology

BIA Separations introduces PrimaS multi-mode ligand bioprocessing technology

16 Jun 2020

Novel platform initially focussed on high-resolution industrial-scale processing of therapeutic mRNA.

Read more 
Pharma’s supply chain prepares for the ‘next normal’ in a post-COVID-19 world

Pharma’s supply chain prepares for the ‘next normal’ in a post-COVID-19 world

15 Jun 2020

Supply chain executives request greater visibility and transparency, especially at the supplier and manufacturer level.

Read more