Pharma manufacturing news in brief
pharmafile | August 14, 2012 | News story | Manufacturing and Production |Â Â Advanced Bioscience, Almac, Amneal, Cipla, Isis, Sanofi PasteurÂ
Cipla opening three new API plants as Indian trade delegations forges closer ties with Sri Lanka; plus facility updates from Isis, Amneal, Almac and Sanofi Pasteur and a new contract for ABL.
Indian drugmaker Cipla has said it will construct three new active pharmaceutical ingredient (API) plants in India – at Patalganga, Bengaluru and Kurkumbh – which are expected to be completed in 2012-13, according to the company’s annual report. The total investment for the three projects is estimated to be around 5 billion rupees (around $91m).
A trade delegation from India has announced plans to set up a pharmaceutical manufacturing hub in Sri Lanka as part of a range of bilateral trade agreements between the two countries, according to the Sri Lanka Sunday Times. The overall package – which also includes oil and gas, agro-processing and tourism investments – is aimed at boosting trade between India and Sri Lana to around $10 billion a year by 2015.
Isis Pharmaceuticals has successfully passed a pre-approval inspection of its manufacturing facility in Carlsbad, California, by the European Medicines Agency (EMA), setting the company up to start supplying partner Genzyme with the active ingredient for its Kynamro (mipomersen sodium) atherosclerosis product as it moves towards a possible commercial launch in Europe. The review covered Isis’ manufacturing facility, processes, and GMP quality systems. Kynamro was filed for approval in the EU in July 2011 and in the US earlier this year.
US generic firm Amneal Pharmaceuticals has earmarked $120 million between now and 2014 to upgrade and expand three of its six R&D, manufacturing and distribution facilities and add 500 new jobs to its current workforce of around 1100. The investment programme will double Amneal’s production capacity and diversify its generics portfolio, said chief executive Chintu Patel. The drive will add new capabilities in high potency medications, controlled substances, softgel capsules, transdermal patches and injectables, as well as take the company into new therapeutic areas such as oncology.
Northern Ireland-based Almac has expanded the refrigerated storage capacity at its main UK site and added new refrigerated labelling facilities in the face of “a growing number of client requests involving biologics, biosimilar compounds and other temperature-critical material”. The expansion programme has doubled capacity at the Craigavon plant and mirrors its US facility in Souderton, Philadelphia.
Sanofi Pasteur recently suspended production at a manufacturing facility in Toronto, Canada, after a mould contamination problem resulted in a citation by the FDA. The company said the plant – which makes bladder cancer treatment Theracys BCG-IT and tuberculosis vaccines – will be updated and renovated and interruptions in supply could extend into 2013. The company as recently forced to recall TB vaccines on the grounds that it could not guarantee stability. The FDA sent Sanofi Pasteur a warning letter about the compliance issues at the plant in July.
Advanced Bioscience Laboratories has been awarded a contract to supply pre-clinical development and good manufacturing practice (GMP) manufacturing support for multiple vaccine and biologic products for infectious diseases supported by the US National Institute of Allergy and Infectious Diseases (NIAID). The contract covers services from feasibility studies to the production of clinical trial materials for Phase I/II studies.
Phil Taylor
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