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Last Updated on Freitag, 22 Juni 2018 08:41 Written by admin Dienstag, 11 Dezember 2012 05:52



  • 7 Million Euro for New Quality Control Building

    Excella is investing another 7 million Euro in Feucht. On March 24th 2016 the construction of a new laboratory building started, that will be used for the quality control of drug products from 2018 onwards.

    In the new building there will be two office floors, three lab floors, basement and attic. All functions that serve Quality Control will be concentrated in one building and provides room for 78 workplaces. Presently, the erection time is estimated to two years, then the most striking building on the Excella premises will be ready.

    During the previous years the manufacturer of pharmaceuticals and supplier of quite a number of drug vendors has grown continuously. In 2008, the company opened its chemical technical center, for which 17.4 million Euro were invested.

    Since the former Heumann production site was purchased by the French Fareva group, the number of employees has increased from 400 to now 540. In 2015 Excella achieved an annual turnover of about 106 million Euros.

    The drug products of Excella are manufactured under technically challenging clean room conditions, that also allow for the production of highly active ingredients. In this field, Excella is one of the leaders worldwide and is shipping its products to customers in more than 50 countries.

    In the medium term, more new buildings are planned in Feucht. Apart from expanding the production of chemicals, a new building for the production of drugs shall be tackled, as well.

       New Quality Control Building

    Quality Control Building

    With a height of 24 meters and a floor area of 4,200 square meters the new Quality Control will be the most striking building on the Excella premises.



  • Inspections by Korean MFDS and Turkish MoH

    In 2016 we continued our series of successful inspections by regulatory bodies.

    Korean MFDS

    Excella GmbH & Co. KG was inspected by the Korean Health authority in April. Two inspectors reviewed the site and DP related GMP systems from April 11th – 13th. After 3 days of intensive work the inspection was completed sucessfully.

    Turkish MoH

    Excella GmbH & Co. KG hosted two inspectors of the Turkish MOH in June. This inspection focused on DP and was triggered by three different products of different customers. At the close-out session after 5 days of inspection the inspectors confirmed the good GMP status of the site.



  • TEAM EXCELLA

    Betriebssport ist gut für Gesundheit, Betriebsklima, Teambuilding und die Identifikation mit unserer Firma.

    Untersuchungen zeigen:  In Unternehmen, in denen die Mitarbeiter regelmäßig Sport treiben, sinkt der Krankenstand. Die Arbeitnehmer sind belastbarer und gesünder. Die gemeinsame Bewegung stärkt den Zusammenhalt, verbessert das Betriebsklima und motiviert. Außerdem wirkt sich der gemeinsame Betriebssport positiv auf das Firmenimage aus. Weiterlesen



  • New electrically powered vehicle

    Excella is driving ecofriendly.

    The fleet of our commercial vehicles was expanded. From now on there is an environmentally friendly electric transport vehicle available. It can be used for small transport purposes. Weiterlesen



  • Successful SafeBridge® Re-Certification

    Based on the Certification criteria established by SafeBridge® and the assessment performed during 2011, SafeBridge® recently recertifies that Excella meets current industry standards for the safe handling of high potent active pharmaceutical ingredients in chemical synthesis and in solid oral dosage production based on SafeBridge’s knowledge of potent compound manufacturing practices in the pharmaceutical industry. Weiterlesen



  • Excellence in Critical Compound Safety Handling

    Excella GmbH in Feucht , Germany has met the criteria established under the SafeBridge® program for „Potent Compound Safety Certification“ and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) and potent drug products. Excella becomes the first company worldwide to achieve SafeBridge® Potent Compound Safety Certification for the manufacture of oral solid dosage forms (OSD).

    read full article



  • ATACAMA LABS ENTERS INTO PARTNERSHIP WITH EXCELLA GmbH

    The Finnish company ATACAMA LABS OY and EXCELLA GmbH (Fareva Holding SA) have signed a contract manufacturing agreement to jointly market and sell PDG granule and tablet manufacturing services for the pharmaceutical industry. Excella / Atacama Labs Offer for the Pharmaceutical Industry: Atacama Labs Oy has developed an innovative oral drug delivery technology called „pneumatic dry granulation“ or „PDG Technology“). The technology is aimed to replace existing solid dosage form development and manufacturing methods (like wet granulation or standard roller compaction) and will help both NCE galenic developers and life cycle managers to overcome development or differentiation issues. The Excella / Atacama Labs partnership offers a cGMP compliant and FDA / EMEA / Anvisa certified environment to house Atacama’s innovative and fully automated PDG equipment. „We can develop almost any API (including difficult ones) into higher drug load tablets with good hardness and dissolution profiles and our clients can profit from new tablet characteristics to extend the life cycle of expiring drugs, which can mean several more years of protected sales of a blockbuster drug. In both cases, global economics can be hundreds of millions of additional revenue, naturally subject to magnitude of drug revenue,“ Mr. Mittwich, CEO of the Atacama Labs Oy concludes. „Atacama Lab’s Pneumatic Dry Granulation or PDG Technology is revolutionary in the sense that it offers significant advantages in terms of API treatability, development speed and costs over today’s dry and wet granulation processes“ Dr. Michael Tschöpe, General Manager Pharma, Excella GmbH about Atacama Labs Oy. Atacama Labs Oy is a privately owned specialty pharmaceutical company that offers galenic development from test granulations to full galenic development, and contract manufacturing services from tablets to fully packaged products. The Company is located in Helsinki, Finland. For further information, please contact: Dr. Michael Tschöpe, General Manager Pharma, Excella GmbH, tel. +49-9128-404500 mtschoepe@excella-pharma-source.de; Steffen Mittwich, CEO Atacama Labs Oy, tel. +41 79 369 3410



  • New Small Scale API Facility Operational – One Stop Shopping in High Containment Services

    After only 15 months construction time Excella’s New Small Scale API Facility was completed and became operational in July 2009. The new facility has three compartments which are completely independent of and separated from each other with separate air handling systems, separate access, etc. Two of the compartments are designed for handling highly active API’s and are OEB 5 compliant, with reactors in the size of 250 and 800 liters, respectively. The third compartment, again with 800 liter reactors, is used for standard substances. In addition, a kilo lab is available with 60 liter reactors installed. This allows for batch sizes from a few up to 150 kg. Excella’s new facility provides state-of-the-art containment services. The facility operates to current Good Manufacturing Practices and can produce material for preclinical testing, clinical trials and commercial use as it serves Excella as a pilot plant and a small scale manufacturing unit. Highly potent molecules produced in Excella’s new high containment API facility can seamlessly flow into Excella’s drug product manufacturing division on site. Our Pharma colleagues are specialized in the manufacture of solid dosage forms of highly active or toxic substances with particular claims for product, staff and environmental protection. We are a market leader in high containment tablet and capsule production with two units that are OEB 4 and OEB 5 compliant. So, if requested by the customer, Excella can offer a one-stop-shopping solution ranging from process development through API production to the packed finished dosage form.



  • New CEP for BACLOFEN

    In August 2009 the EDQM granted a new Certificate of Suitability for Excella’s API BACLOFEN. This increases the number of actual CEP’s for our products to fourteen. Our Regulatory Affairs & Customer Service Department is happy to send copies of these certificates to our customers for the respective products. Please contact Frank Jellen at +49 9128 404 685 or by e-mail to fjellen@excella-pharma-source.de with your inquiry.



  • New CEP for Alfuzosin HCl

    By April 1st 2009 the EDQM granted a new Certificate of Suitability for Excella’s API Alfuzosin HCl. This increases the number of actual CEP’s for our products to thirteen. Our Regulatory Affairs & Customer Service Department is happy to send copies of these certificates to our customers for the respective products. Please contact Frank Jellen at +49 9128 404 685 or by e-mail to fjellen@excella-pharma-source.de with your inquiry.



  • Excella’s New Small Scale Facility

    The construction of Excella’s new Small Scale Facility for high containment products is well on track. Groundbreaking took place on March 5, 2008 and building construction was completed in early November. The new facility will be operational on July 1, 2009 and will give Excella state-of-the-art manufacturing compartments for OEB 4 and OEB 5 substances in the scale from 2 kg up to 100 kg.



  • Heumann PCS is now Excella

    We are glad to announce that the registration of our new company name EXCELLA GmbH with the German Authorities has been finalized by 31.03.2008.

    This change from  Heumann PCS GmbH to EXCELLA GmbH is a pure name change only without any effects on our location / production site at Nuernberger Str. 12, 90537 Feucht, Germany.
    If you have any concerns or questions related to our name change please feel free to contact us.



  • TODAY, PHARMACEUTICAL OUTSOURCING

    TODAY, PHARMACEUTICAL OUTSOURCING has grown into a sizable industry in itself. The total global market for contract manufacturing, according to PharmSource, is roughly $30 billion per year, growing at 8-10% annually.

    API and dosage form outsourcing represent the largest segments; approximately 30% of API production (representing $9 billion) and 26% of dosage form and packaging activities ($7.8 billion) are currently being outsourced.The reasons for the growth in contract manufacturing are certainly well established, but what is not as broadly understood is the issue of outsourcing high containment operations (HCO), one of the industry’s most pressing topics…“



  • Heumann PCS now part of FAREVA

    Pfizer Global Manufacturing finalized the announced divestiture of Heumann PCS in Feucht, Germany by end December 2007. Heumann PCS has been acquired by FAREVA, a proactive France based organization with focus on contract manufacturing for the pharmaceutical and cosmetic industries (www.fareva.com).

    This acquisition is a strategic complement for the FAREVA organization in contract manufacturing of formulations and API’s. The change of ownership will have no impact with regard to any actual supply services or partnership commitments of Heumann PCS.

     

    Please be assured that the Heumann PCS business and the Feucht manufacturing site will maintain the excellent product quality and customer service level that have defined our business relationship with your company.  The decision for FAREVA will allow the site to improve its profile as contractor and will ensure a complementary business plan in future.  

     

    If you should have any questions, please do not hesitate to contact us.

Recent Posts

 


7 Million Euro for New Quality Control Building

Excella makes second large investment since 2008 – Sum of investments totaling to 24.4 Million Euro – In the world’s top position

 


Inspections by Korean MFDS and Turkish MoH

in 2016 we continued our series of successful inspections by regulatory bodies.