Ubichem approved for commercial cGMP API production

Published: 18-Feb-2007
Ingredients

Ubichem Research, in Eastleigh, UK and Budapest, Hungary, has completed its first regulatory audit and is now approved by OGYI (Hungarian National Institute for Pharmacy) for the commercial supply of cGMP Active Pharmaceutical Ingredients (APIs).


Ubichem Research, in Eastleigh, UK and Budapest, Hungary, has completed its first regulatory audit and is now approved by OGYI (Hungarian National Institute for Pharmacy) for the commercial supply of cGMP Active Pharmaceutical Ingredients (APIs).

Reciprocal agreements mean that this approval is effective throughout the EU.

Ubichem Research Kft is the custom synthesis and manufacturing arm of Ubichem UK. Roger McDonald, director, Ubichem Research, said: "This is a fantastic achievement, a real testament to the skill of our dedicated team in Budapest. Having been manufacturing quantities of API for clinical trial, this approval represents a major step forward in our business and is a clear demonstration of our commitment to quality - allowing us to support our pharma and biotech clients all the way from candidate nomination to market."

A $1m investment in new and upgraded analytical, development and production capacity is already underway at the company's facilities. This is expected to be completed during 2007.

  • Companies:
  • Ubichem
See more

You may also like

Ingredients

Ubichem Group adds manufacturing site in Hungary

Read more
To produce fine chemicals in large quantities and expand presence in non-pharma sector

Trending Articles

  1. Causes and solutions for dark spots in tablet manufacturing Natoli Engineering examines the causes and solutions for dark spots that can halt production
  2. Abzena Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor our strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule. Our global locations include San Diego (CA, USA), Bristol (PA, USA), and Cambridge (UK).
  3. Highly potent APIs: Hazards in classification and handling This variability and subjective nature of classification means that the OEL is best considered as a tool for site risk management teams
  4. Rousselot and IamFluidics launch dissolvable microcarrier for cell culturing The alginate and denatured collagen based product allows researchers to produce scalable cell cultures for biologic drugs and cell therapies
  5. Biosynth appoints Matt Gunnison as its new CEO and Kieran Murphy as Chair Matt and will both assume their places on the Board of Directors, and will work to strengthen the company's position in the life sciences sector

Upcoming event

CPhI Middle East

10–12 December 2024 | Conference | Riyadh, Saudi Arabia See all

You may also like

Ingredients

Ubichem Group adds manufacturing site in Hungary

To produce fine chemicals in large quantities and expand presence in non-pharma sector
Ingredients

Ubichem - Informex 2009 Showcase

<p>Ubichem provides manufacturing, sourcing and supply chain solutions to the pharmaceutical and related industries.</p>
Manufacturing

New facilities significantly extend Ubichem capacity

<p>Ubichem, of Eastleigh in the UK, is investing in additional production capacity in its facilities in Budapest, Hungary. </p>
Distribution

2BScientific expands its life science product supply service to Europe with new German facility

The facility in Munich will serve the European market with life science products, including in vitro diagnostic (IVD) reagents, buffers, biomaterials and antibodies
Ingredients

Rousselot and IamFluidics launch dissolvable microcarrier for cell culturing

The alginate and denatured collagen based product allows researchers to produce scalable cell cultures for biologic drugs and cell therapies
Ingredients

Therapeutic: vimseltinib for tenosynovial giant cell tumour

Tenosynovial giant cell tumour (TGCT) is a rare, non-malignant tumour that results from a translocation in the colony stimulating factor 1 (CSF1) gene
Ingredients

Therapeutic: brensocatib for bronchiectasis

The chronic lung disease bronchiectasis is a serious condition in which the bronchi become permanently dilated because of a cycle of infection, inflammation and damage to the lung tissue
Subscribe now