We make pharmaceuticals better and safer – this is what we are striving for.PharSQ®is more than just a product offer to you.
All ourPharSQ®products are physically and chemically stable excipients. We are reliably fulfilling highest regulation requirements like ICHQ3D elemental impurity level limit values for oral use. We have extended this approach even to thosePharSQ®products, which are not listed in any monograph of the leading pharmacopoeias and are ready to offer further contributions to your risk assessment. A deep level of testing expertise is available in-house: Our lab has qualified state-of-the-art equipment using validated test-methods. All major production lines are certified by EXCiPACT (cGMP and cGDP) with Budenheim achieving this standard in 2014 already, the starting year of this new independent and international standard.
You are striving for the highest safety level: Take a look into ourPharSQ®Activeoffer and enter the world of ICHQ7.
We have a long history in offering excipients and active pharmaceuticals to our customers, which goes back to the 50’s of the last century. We know what we are doing and therefore our customers remain loyal to us. “Made in Germany” means, that we are following solid and controlled manufacturing processes in our Budenheim site. Secured and stable supply bases for raw materials and optimized processes are key to maintain this high quality standard. Thanks to our international network and our market access strategy our products are globally available in the same quality.
Our mission is based on innovation: From new product solutions to formulation and application support. Technical competence is the basis for a close co-operation: Partnership with our customers is our goal. Our technical experts support our partners on a global basis in finding customized solutions. Latest example for a really new product solution isPharSQ®Spheres CM: A unique calcium-phosphate based pellet solution for controlled release applications opening up new opportunities to our partners.
Discover the various product range of Budenheim:
Superior excipients meeting your formulation challenges
Budenheim offers a wide range of excipients for the production of solid oral dosage forms.
DI-CAFOS®andTRI-CAFOS®excipients have been optimized for the use in efficient pharmaceutical production processes, especially for direct compression, dry and wet processes. A high batch-to-batch consistency of Budenheim´s products ensures robust drug manufacturing processes, adding value to your overall productivity and efficiency.
Excellent tabletting properties, particularly high tablet strength and faster disintegration, can be achieved using our excipients. The targeted use of our products also helps to overcome many typical challenges formulation developers face today: From an enhancement of the powder flow due to poor flowing active pharmaceutical ingredients (API’s) to overcoming process or equipment setup limitations, an increase of the chemical and physical stability of the formulation (e.g. when processing pH- or moisture sensitive API’s) to an improvement of re-compactability in dry granulation processes.
我们的辅料也许多新的溶胶的基础ution approaches: By facilitating the manufacturing of lactose-free formulations or of reduced tablet sizes, by increasing efficiency in liquid-to-solid processes and by providing a unique starting material for multiparticulate formulations.
Our newest solution for multiparticulates:
WithPharSQ® Spheres CMwe offer unique calcium-phosphate based starter pellets for controlled release applications opening up new opportunities to our partners.
Many advantages for our customer:
PharSQ®Spheres CMare small beads onto which the drug manufacturer can load the desired active ingredient. The almost perfectly round pellets have a diameter of only 0.1 to 1 millimeter depending on the product grade. The use is versatile, from filling into hard capsules or sachets to compression into tablets. The unique characteristic ofPharSQ®Spheres CM支持加载活性成分的desired dosage, which increases the safety of the drug. Through a combination of differently coated spheres the controlled release of the active ingredient can be optimized: to the targeted place in the digestive tract over the right period of time. In this way, the effectof medicines can be precisely adjusted to the actual needs. During production ofPharSQ®Spheres CMno organic solvent is used. Consequently, there is no risk of presence of organic volatile residuals in the final product. Due to their very low moisture content,PharSQ®Spheres CMcan be safely used with moisture sensitive drug substances, which enhance their stability. Due to the comparatively high density ofPharSQ®Spheres CMtablet or capsule size can be reduced – a substantial benefit particularly for people with difficulty swallowing.
Active Pharmaceutical Ingredients for your formulations:
Budenheim is committed to the pharmaceutical industry since the 1950’s and known for its reliably high quality profile. Being one of the first companies adhering to the newly introduced EXCiPACT standard for pharmaceutical excipients in 2014 was a logical step for us and just an expression of this firm commitment. Due to the high quality, our partners already started to use our products as so-called atypical API’s many decades ago, providing a proven track record also in this application field. Now we have taken the next step in the quality ladder and introduced thePharSQ®Activeline in our portfolio.
PharSQ® Active DCF and Active DM:
PharSQ®Active DCFoffers a reliable source of Calcium and Phosphorous andPharSQ®Active DMa reliable source of Magnesium and Phosphorous for the human body. At the same time physical properties allow the use in standard dosage forms and standard granulation processes. Our Actives are used in drugs for persons, which deserve special protection and therefore the highest quality of a proven and reliable product (e.g. pregnant women).
PharSQ® Active DS:
As part of saline enemasPharSQ® Active DShelps you to promote the osmotic activity. It is also used in related product applications like laxatives.
Our branded offer for biopharmaceutical processes:
In order to achieve the highest quality for your biopharmaceutical product you need to start with a solid base. Budenheim’s portfolio is tailored specifically to your biopharmaceutical process, helping you to reach your quality goals. WithPharSQ®Basewe offer a wide range of products, offering you flexibility to address your needs in the fermentation process and supporting you in creating reliable products. ThePharSQ®Baseportfolio offers a variety of options covering different dissolution rates, pH-value buffering, nutrient levels and physical properties. In this way we can support the optimization of your upstream and downstream processes.
High quality for safer products:
To increase product safety we follow the requirements from the pharmaceutical regulatory environment, which are now fully reflected in our specifications. Chemical quality parameters, including ICHQ3D elemental impurity limit values for oral use, will also be shown for those products, which are not listed in a pharmacopoeia. That way we make a major contribution to your risk assessment now and in the future. Therefore we are your partner of choice in biopharmaceuticals: Challenge us whenever you need reliable product solutions within the synthesis process.