Contract manufacturing news in brief

By Phil Taylor & Nick Taylor

- Last updated on GMT

Related tags: Pharmacology's periodic round-up of developments in
the world of contact manufacturing includes a plant approval for
PharmEng and new contracts for Akorn.

Keata plant gains GMP certification ​ PharmEng's wholly owned subsidiary, Keata Pharma, has received a drug establishment license for its manufacturing facility in Sydney, Nova Scotia. The license was granted following a good manufacturing practices (GMP) inspection and grants Keata permission for the manufacturing, testing and packaging of capsules, powders, solutions and tablets. David Leonard, president of the facility, said: "The Sydney facility is a new state-of-the-art pharmaceutical manufacturing facility with the unique capability to assist clients to bring their products from the laboratory to the market by providing development, scale-up and commercial production expertise​. "The issuance of these licenses coupled with our low cost pharmaceutical production sets the stage for significant growth in the future​." The facility has now begun commercial production with shipping of product commencing immediately. Akorn wraps up two deals ​ Akorn has signed a ten year exclusive contract manufacturing supply agreement with an unnamed pharmaceutical company. The contract gives Akorn responsibility for the manufacturing and supply of several injectable drug products, which it anticipates will generate annual contract revenue of $4m to $5m over the life of the supply agreement. Arthur Przybyl, Akorn's President and Chief Executive Officer stated, "This agreement reflects Akorn's commitment to providing high quality contract manufacturing services to the pharmaceutical industry. We look forward to supplying these important drug products from our Decatur, IL facility​." The ten year deal caps a busy week for Akorn, which also struck a five-year agreement with Bioniche Pharma for the manufacturing and supply of two hospital injectable products that are due to launch later this year. Plethico cuts back on CRAMS ​ Plethico Pharmaceuticals has signaled its intent to cut back on its Contract Research and Manufacturing Services (CRAMS) business as higher inflation and rising crude oil prices put the squeeze on profit margins. Sanjay Pai, Plethico's chief financial officer, said: "We will trim our CRAMS business because the margins are getting squeezed out. Many of our CRAMS deals are coming up for renegotiation and if we don't get what we want, we have to trim that vertical​." Plethico claims its CRAMS business generates revenues of more than $23m per annum, with the majority of its clients being Indian pharmaceutical companies. Despite the planed cut backs the Company is investing $23m setting up a fully automated plant in Dubai for the manufacture of medicated lozenges at an investment of Rs100 crore. This facility will be used to supply the Gulf region, US and UK. FloridaBiologix wins manufacturing contract ​ Florida Biologix has been awarded a manufacturing contract from the National Taiwan University Hospital, which will involve the production of a Phase I clinical batch of a novel therapy for a rare genetic disease - aromatic amino acid decarboxylase (AADC) deficiency. Deficiency of AADC disrupts the formation of the neurotransmitters dopamine and serotonin is impaired and the passage and signalling within the brain is disrupted, causing problems with movement, mood and sleep patterns. The award is a boost to Florida Biologix, which is only in its second year of operations. The US firm specialises in the manufacture, testing and filling of biopharmaceuticals Dr.Paul Wuh-Liang Hwu of National Taiwan University Hospital said the contract went to Florida Biologix because of its "track record of expertise in biopharmaceutical manufacturing and testing, including capabilities to make material for both preclinical and clinical trials​." Patheon extends relationship with SK Life Science ​ Patheon has been selected by SK Life Science as the development services partner for two of the Korean company's central nervous system drug candidates. This extends an existing business relationship between the two companies. Patheon recently completed Phase I development and clinical materials manufacturing for SK Life Science's pain drug candidate. "Patheon produced quality clinical materials for the pain drug project within our timelines. As a result we were very comfortable with awarding Patheon these two additional key projects​," said Dr James Lee, vice president, pharmaceutical development, at SK Life Science. Patheon will provide formulation and analytical development services as well as clinical supplies for one of the CNS candidates in multiple dosage forms, as well as development and clinical materials manufacturing services for another CNS candidate in Phase I clinical trials. The global CNS market is expected to grow to $63.9bn by 2010, according to Urch Publishing.

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