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NEWS

May 16, 2017      FDA-Inspektion - PharmaZell Schweiz GmbH

PharmaZell Liestal site, Switzerland successfully passed a FDA inspection in January 2017.

Apr 1st, 2016     Acquisition of majority shares in joint venture

On April, 1st 2016 PharmaZell has acquired a majority stake in a new JV created from the bile business of Fayman International (Australia). With this step PharmaZell has secured the raw material for its production of ursodeoxycholic acid (UDCA) collecting bile directly from slaughterhouses worldwide.

The JV consists currently of three entities: Pharmachol India, Pharmachol Australia and Pharmachol South Africa. More collection centers will be founded in due course. This way PharmaZell is in the unique position to control the entire supply chain from collection of bile from hundreds of slaughterhouses worldwide right to the conversion to UDCA at its Swiss plant using our novel enzymatic process.

The conversion from bile to UDCA is done by using proprietary technology applying new enzymatic systems to achieve selective conversions in the API sysnthesis. EDQM has already granted a CEP for this process.

 

Dec 16, 2013 / Feb 03, 2014     PharmaZell sold to DPE

On 16th December 2013 DPE German Private Equity signed – together with the management - the contracts for a majority share acquisition of the ZellBios Group. On February 3rd 2014 the sale has been closed.

The Munich based investment company DPE, under the direction of Marc Thiery, now made in a short time their second long term investment in the health sector.

Dr. Oliver Bolzern and the management team will continue to lead the ZellBios Group today which consists of Farmabios SA and PharmaZell GmbH. To the ZellBios Group belongs PharmaZell and Farmabios with sites in Germany, Switzerland, Italy and India.

 

Dec 13, 2013     PharmaZell employees donate in favor of DKMS
                         (DKMS = German Bone Marrow Donor Database)

Inspired by the appeals for donations for Baby Emilie from Raubling many employees were willing to buy raffle tickets during the PharmaZell company Christmas dinner.

The 3 main prizes were sponsored by the management and corporate partners.

A final amount of 1250,-Euro has been donated, which now benefits the typing of 25 new donors and potentially 25 sufferers!

On Tuesday, 12.17.2013 Mr. Robert Richter (HR) and Mr. Markus Rastinger (works council) presented the money to Mr. Florian Babel (Donor Club Member DKMS and bone marrow donor).

Many thanks again to the generous donations of the PharmaZell employees! 

 

Oct 18, 2013      ISO 50001:2011 certification for the Raubling Site

The PharmaZell Raubling site has been officially certified for its efficient energy management with ISO 50001:2011. As already reported in the press in November 2012, PharmaZell pays attention to a resource saving production. With the help of a fund from the Ministry of Economy, the energy saving project has now been successfully implemented.

ISO 50001:2011 provides a framework of requirements for organizations to: - Develop a policy for more efficient use of energy; - Fix targets and objectives to meet the policy; - Use data to better understand and make decisions about energy use; - Measure the results; - Review how well the policy works; - Continually improve energy management

 

Jun 19, 2013      Written confirmation for API imported into EU issued

PharmaZell is pleased to announce that the Indian regulatory body CDSCO (Central Drugs Standard Control Organization) has issued Written Confirmations for our manufacturing sites in Vizag and Chennai, confirming that these sites were inspected according to ICH Q7 guidelines. Such written confirmations will be required starting July 2, 2013 according to Article 46b(2)(b) of EU Directive 2001/83/EC for imports of active pharmaceutical ingredients into the EU.

 

Feb 27, 2013      PharmaZell adds manufacturing site

PharmaZell has added an additional European manufacturing site to its production network of German and Indian sites. It is located in Liestal, Switzerland and licensed by SwissMedic to manufacture small molecule active pharmaceutical ingredients and controlled substances. 

 

Dec 5, 2011      Site Raubling successfully inspected by FDA

PharmaZell GmbH is pleased to announce that its manufacturing site at Raubling, Germany, has successfully passed a FDA inspection in the week of December 5th, 2011 without any FDA form 483 observation. This inspection outcome reconfirms the GMP compliance of Raubling site of last FDA inspection in 2007.

 

Nov 24, 2011      Joint development agreement with German university

Pharmazell has entered into a joint development agreement with a reputable university in Germany in the field of biocatalysis. Under this 3 years' cooperation agreement specific technologic reactions like stereoselective reductions will be investigated and optimized. The results will be commercialized by Pharmazell exclusively.

 

Nov 10, 2011      Site Chennai successfully inspected by FDA

PharmaZell (India) Private Ltd.is pleased to announce that it has successfully passed an FDA inspection which has been performed at its Chennai site in the week of November 7th, 2011 without any FDA form 483 observation. This inspection was the second FDA inspection of the site following the first successful FDA inspection in 2008.