Pharma manufacturing news in brief

pharmafile | October 12, 2011 | News story | Manufacturing and Production pharma manufacturing news 

FDA sets aside $35m for manufacturing research, Anteco, Apicore and Vetter provide facility updates and Domino Printing sets up a group to help customers meet the EU’s falsified medicines directive requirements.

The FDA has awarded a grant of $35 million to the National Institute for Pharmaceutical Technology and Education (NIPTE) over the next five years for projects designed to improve drug manufacturing standards. The US regulator said it intends to improve drug safety, cut health care costs and create jobs through this move. Specific targets for the project include improving small-batch production, promoting continuous manufacturing, reducing costs and cutting the environmental impact from pharmaceutical manufacturing.

US contract manufacturing organisation Anteco Pharma will expand its production facility in Lodi, Wisconsin, via a $3.5 million investment programme. The company specialises in providing freeze-drying and packaging services for the pharmaceutical and medical device sectors, and said the investment was being driven by a rise in demand for clinical manufacturing support. Its overall aim is to achieve a tenfold increase in revenues by 2016 and quadruple its workforce from the current level of 20 staff.

UK printing and coding specialist Domino has set up a dedicated workgroup to help its customers implement the product identification features mandated by the recently-adopted EU falsified medicines directive. The 30-plus member group will consist of local experts from across Europe in areas such as legislative standards, validation of automated manufacturing good practice, code formats and serialisation. The directive calls for the introduction of obligatory identification and authentication features on medicine packs, as well as tamper-evident labels.

The FDA has given a clean bill of health to Apicore Pharmaceuticals‘ manufacturing facility in Vadodara, Gujarat, India. The company can now supply active pharmaceutical ingredients from FDA-inspected plants located in both the USA and India. The company said its manufacturing plant in India creates a low cost option to supply larger volumes of API to a global healthcare market “where cost containment is a priority for governments and private payers alike”.

German contract development and manufacturing organisation Vetter, which specialises in aseptic filling, has said that its first US facility is now fully operational. The 24,000 sq.ft. plant is located at the Illinois Science and Technology Park in Chicago and includes microbiology and chemical analysis laboratories, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection. The unit can handle projects from preclinical through Phase II development.

Phil Taylor

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