Pharma manufacturing news in brief
pharmafile | May 9, 2011 | News story | Manufacturing and Production |Â Â Â
This week’s roundup has new contract awards for Aptuit and SAFC, plus facility updates from Cangene, Carbogen-Amcis and Aanjaneya Lifecare.
Aptuit has won a contract to manufacture novel pain medicines developed by Iroko Pharmaceuticals, which are due to start phase III testing shortly. Under the terms of the agreement, Aptuit will make phase III supplies of multiple non-steroidal anti-inflammatory drugs made using Iroko’s proprietary SoluMatrix drug delivery technology, as well as batch material for product registrations. Iroko has already completed phase II studies for all of these products, which should offer effective pain relief at lower doses of the NSAID.
Contract manufacturing organisation SAFC has signed an agreement to improve the production process for an active pharmaceutical ingredient (API) used in Davanat (GM-CT-01), a drug product in development at Pro-Pharmaceuticals. Davanat is a carbohydrate polymer that targets Galectin proteins, which are over-expressed in cancer cells, and interferes with their activity. Davanat is due to start phase II testing in metastatic colorectal cancer patients later this year, following FDA approval of the pivotal trial protocol in January.
Cangene has completed an $11 million renovation of a sterile filling and support facility operated by its contract manufacturing subsidiary Cangene bioPharma. The renovation adds a second production freeze-dryer and “significantly increases overall throughput capacity” as well as bringing the unit up to standard for new regulatory requirements around the world for vials and pre-filled syringes, according to the company. “We see increasing opportunities arising from the elimination of fill capacity by many pharmaceutical companies during the economic downturn,” said Vicki Wolff-Long, general manager of Cangene bioPharma.
Swiss fine chemical company Carbogen-Amcis says its recently-completed high potency API facility in Ahmedabad, India, has successfully passed a containment performance evaluation and meets category IV standards. The facility, which is located on the site of parent company Dishman Pharmaceuticals and Chemicals, produces APIs in using isolator technology and can now manufacture compounds up to the highest occupational exposure band, including category 1 carcinogens.
Indian company Aanjaneya Lifecare plans to start manufacturing around a dozen anticancer APIs drugs at a new facility currently being constructed at Mahad in Maharashtra in the next 12 months, according to a Press Trust of India report. The primary aim will be to provide locally-made APIs for smaller Indian drugmakers which at present generally import them from China. Aanjaneya currently exports APIs to 15 countries, including Kenya, Cyprus, Jordan, Argentina and Brazil.
Phil Taylor
