AqVida: Defining quality in oncology

Overview

AqVida is a German pharmaceutical company, specialized and dedicated to development and production of onco-generics.

A wide range of oncology products (parenteral and solid forms / MAs granted in Europe) are available for immediate MA transfer.

AqVida has recently completed its new, innovative manufacturing site in Germany. This state of the art manufacturing facility enables the company to extend its established leadership in oncology products for the German/European market.

The innovative plant is Europe’s first 100% robotic controlled facility for aseptic filling of parenteral oncology products and ADCs, increasing AqVida’s flexibility and efficacy in vial filling and production.

Features and benefits

The high degree of automation and modular design offers a series of client benefits:

• Short set-up times
• Total control and tracking of every single vial throughout the production process
• No use of format parts, supporting ultra-fast format changes
• 100% weight controlled filling on a weighing-cell
• Zero loss, with full recovery of product from stopper or cap rejects
• Variable batch sizes from 10 to 300 liter
• Capability to fill cytostatics and antibody drug conjugates (ADCs)
• Manufacturing capability for products up to OEB5

Oncology portfolio

The new capacity has allowed AqVida to extend its range of oncology products. Currently available products include solid forms and parenteral/injectable products.

Parenteral / Injectable Forms – “Made in Germany”

• Docetaxel, solution for infusion / 20mg/ml [20mg, 80mg, 140mg, 160mg]
• Epirubicin, solution for infusion / 2mg/ml [10mg, 20mg, 50mg, 100mg, 200mg]
• Filgrastim solution for injection [300mcg, 480mcg] – not in Europe, outside EU for non-regulated markets
• Irinotecan, solution for infusion / 20mg/ml [40mg, 100mg, 300mg, 500mg]
• Oxaliplatin, solution for infusion / 5mg/ml [50mg, 100mg, 150mg, 200mg]
• Paclitaxel, solution for infusion / 6mg/ml [30mg, 100mg, 300mg]
• Gemcitabine, lyophilisate for solution for infusion [200mg, 1g, 2g]

Solid FormsM

• Azathioprine, film-tablets [25mg, 50mg]
• Imatinib Mesylate Capsules [100mg, 200mg, 400mg]
• Sunitinib Maleate [12,5mg, 25mg, 37,5mg, 50mg]

Under development:

AqVida is now ready to manufacturer high-quality Sunitinib and Imatinib (INN) , as generic oncology therapeutic products, both in capsule form. Both products have completed European development phases, with manufacture of APIs and backward integrated FDFs (finished dosage forms) sourced to patent-free zones, supporting fast market commercial production in territories where no patent applies.

Sunitinib will be available in 12.5mg, 25mg, 37.5mg and 50mg capsule forms while Imatinib-AqVida capsules are now available in 100mg, 200mg and 400mg formats with upcoming line extension to 200mg strength.

Benefits of partnering with AqVida

Most of below dossiers count with multiple marketing approvals in Europe, mainly in Germany. AqVida maintains all-important MAs and is able to offer immediate access to approvals for Poland, United Kingdom, France, Italy, Bulgaria, Romania and Germany.

For export territories outside the EU, AqVida provides CPPs from Germany.

AqVida does not have an own sales force; its supply chain ends with license-/distribution, leaving partners free to focus on last step into the market to sell to compounding pharmacies, doctors/oncologist, tender business, etc. AqVida does not compete with its license-partners.

AqVida holds a significant market share in Germany (via its license partners) and is currently expanding its business on a pan-European level.

Extensive Inventory

AqVida holds inventory of bulk, unlabeled parenteral forms in its German warehouse.

This enables the company to offer highly flexible service with short lead-times and the ability to handle small SKUs. Furthermore, it is able to split batches on behalf of license-partners and negotiate MOQ without having to insist on purchases of full commercial batches.

Resources

Click on AqVida: Defining quality in oncology for more information.
Click on AqVida to contact the company directly.

Supplier Information
Supplier: AqVida GmbH
Address: Kaiser-Wilhelm-Str.89, 20355 Hamburg, Germany
Tel: +49 40 380 37190
Fax: +49 40 380 37192
Website: www.aqvida.com