Breaking News on Pharmaceutical Technology

Contamination found in Genzyme drugs; no FDA ban

16-Nov-2009 - . In March, the FDA uncovered a number of deviations from current good manufacturing practice (cGMP ... Genzyme, FDA, contamination, cGMP

O’Hara launches 3-in-1 coating

02-Nov-2009 - and tray dry oven inserts to cut capital expense and GMP spaced needed perform these tasks. ... and tray dry oven inserts to cut capital expense and GMP spaced needed perform these tasks. ... to reducing expenditure, both in terms of initial capital investment and good manufacturing practice (GMP

News in brief

Korsch and ACG set up tabletting machine JV

27-Oct-2009 - good manufacturing practice (GMP) standard production plant in Mumbai. Korsch spokesperson Nerea ... Korsch, GMP, ACG, tablet

APC’s new R&D unit to focus on complex peptides

21-Oct-2009 - manufacturing practice guidelines (cGMP) APC can take a flexible approach. Large-scale manufacturing drives

EC GMP directive “still alive”; Cargill

19-Oct-2009 - EC GMP directive “still alive”; Cargill ... The EC’s plan to make excipients comply with GMP is “still alive”, according to Cargill which ... The EC’s plan to make excipients comply with GMP is “still alive”, according to Cargill which ... with good manufacturing practices (GMP) but Cargill believes the issue will be raised again in the future with GMP, adding that Cargill’s operations are already run to exacting quality standards ... excipient, Cargill, GMP

Dow launches flake PEG at CPhI

14-Oct-2009 - of which are compliant with current good manufacturing practices (cGMP). By entering the market

ATMI launches single-use powder transfer bag

30-Sep-2009 - quickly establish a current good manufacturing practice (cGMP) compliant operation at the Bloomington site.

Hovione's Loures plant gets latest FDA pre-approval nod

30-Sep-2009 - seen and commended Hovione’s good manufacturing practice (GMP) System and knowledge of its team members

FDA proposes cGMP rule for combination products

29-Sep-2009 - FDA proposes cGMP rule for combination products ... The FDA is to establish current good manufacturing practice (cGMP) requirements for combination ... The FDA is to establish current good manufacturing practice (cGMP) requirements for combination ... Currently the US Food and Drug Administration’s (FDA) guidance covers cGMP requirements . Respondents added that this should avoid unnecessary redundancy in cGMP operating systems. Having

Genzyme starts work on new Mass facility

17-Sep-2009 - “one major [GMP] observation,” is still being addressed, Genzyme’s investment in the new facility ... alemtuzumab, LEED, Genzyme, EMEA, manufacturing, distribution, GMP

PPD targets NJ, PA

19-Nov-2009 - and neighbouring New Jersey and Magdalena Mejillano, vice president of PPD's cGMP (current good manufacturing and will be certified in January 2010, after which PPD will be able to conduct cGMP testing. Establishing a

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Catalent: Irish pack plant gets ISO 15378; Swindon job cuts

17-Nov-2009 - and then implemented. The entire staff had to receive GMP training on the new standards as well as training in product ... Catalent, Zydis, GMP, packaging, ISO

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News in brief

Lonza to manufacture GSK’s Arzerra

17-Nov-2009 - manufacturing practice (cGMP) compliant production to support the licensure and has now expanded

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Delivery Science teams up with URI for testing services

12-Nov-2009 - practices (cGMP) facility in Putnam, Connecticut. Listro said that the aim of the partnership ... formultaion, URI, Delivery Science, cGMP, hot melt, API

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AFMPS OK for NextPharma's sterile product development centre

04-Nov-2009 - are delighted to report that following on from this successful inspection we will immediately commence GMP ... AFMPS< GMP, pre-formulation, NextPharma, Phase III, clinical

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Alpha acquires CRO to target Mass bio

29-Oct-2009 - manufacturing practice (cGMP) compliant laboratory, from which it offers services including stability testing

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Quintiles to open Phase I site in ‘experimental medicine’ hub

28-Oct-2009 - (GMP) pharmacy and the Biomedical Research Centre’s (BRC) new Faculty of Translational Medicine, which

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Melbourn launches tablet imaging service at CPhI

14-Oct-2009 - clients but lacks good manufacturing and laboratory practice (GMP and GLP) facilities, according

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Pharmatek installs Xcelodose to cut development time

05-Oct-2009 - Pharmatek has enhanced its preclinical and early stage clinical GMP supply capabilities ... Pharmatek has enhanced its preclinical and early stage clinical GMP supply capabilities ... manufacturing practice (GMP) requirements.

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News in brief

BioVectra wins contract to make Prolanta for trials

29-Sep-2009 - Vectra as our contract manufacturer because of their ability to produce cGMP manufacturing of Prolanta from

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