Pharma manufacturing news in brief
pharmafile | July 23, 2013 | News story | Manufacturing and Production |Â Â Fujifilm, Molecular Profiles, Penn Pharma, Rafarma, Riboxx Pharma, United Arab EmiratesÂ
UAE ‘s bid to boost domestic drug industry plus facility updates from Penn Pharma and Molecular Profiles head our round-up of pharma manufacturing news.
The United Arab Emirates has said it will allow generic pharma companies to import active pharmaceutical ingredients (API) that are nearing patent expiry in a bid to encourage the development of the domestic drug manufacturing sector. The aim is to make sure that the generics are available on the market as soon as patent protection expires, says a report in Gulf News. The move should result in generics reaching the market 18-24 months quicker than at present.
Penn Pharma of the UK has said it will invest £3 million ($4.6m) in additional tablet manufacturing and coating capacity at its facility in Tredegar, South Wales, having already spent £14 million on an expansion of its facility there last year, adding high-potency active pharmaceutical ingredient (HPAPI) containment capacity to its existing clinical and commercial solid dose manufacturing. “We are making this additional significant investment to meet our growing customer demands,” said Penn’s chief executive Richard Yarwood.
Contract research and manufacturing organisation Molecular Profiles has been given a green light from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a second clinical manufacturing facility in Nottingham. The 30,000 sq. ft. unit has been constructed at a cost of around £9 million and is designed to handle a range of non-sterile dosage forms such as solids, liquids, semi-solids and inhaled products, including HPAPIs. The unit has six GMP suites, laboratories and a clinical packing area to support Phase I and II clinical trial projects.
Fujifilm Diosynth Biotechnologies has started manufacturing a Synthetic Biologics drug called SYN-004, which is designed to treat infections caused by the bacterium Clostridium difficile. Fujifilm is applying a proprietary expression system – called pAVEway – that creates high-yield cell line for therapeutic protein production using antibiotic-free microbial fermentations. SYN-004 is a recombinant beta-lactamase enzyme that is currently in pre-clinical development.
Riboxx Pharmaceuticals‘ has been awarded a European patent for a novel process for manufacturing double-stranded RNA (dsRNA) with increased stability in biological fluids. dsRNA is emerging as a new treatment approach for a range of indications by switching off disease-associated genes. The patent covers a production-scale method for making chemically-modified dsRNA that improves resistance of the drugs to enzymatic degradation in the body.
Rafarma Pharmaceuticals has signed an exclusive contract with fellow Russian company JSC F-Synthesis for the production of the oral cancer drug imatinib, the active ingredient in Novartis’ chronic myeloid leukaemia treatment Glivec. Imatinib’s market in Russia amounted to a little less than $200 million last year, according to Moscow-based JSC F-Synthesis, which said it sold $30 million-worth of the drug in 2012.
Manufacturers of pharmaceutical production equipment in India have asked the government to impose anti-dumping duties on machines imported from China, arguing that unrestricted trade in low-cost goods is threatening their businesses, reports Pharmabiz. There are reported to be around 800 small and medium-sized pharmaceutical machine manufacturing and allied service units in the country, says the paper.
Phil Taylor
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