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Pharma/Fine Chemicals Roundup – March 13
8:22 AM MDT | March 13, 2012 | By DEEPTI RAMESH
U.S. Bill Would Fund FDA Pharma Inspections
By Kara Sissell
Several U.S. lawmakers have introduced a bill that would result in more resources for FDA officials to conduct inspection of overseas drug ingredient manufacturers. The terms of the House of Representative's generic drug and biosimilar user fee act have been a long-standing priority for Socma, which has a bulk pharmaceutical task force working on the issue. Socma says up to 40% of U.S. pharmaceuticals and up to 80% of drug intermediates are imported.
One of the goals of the bipartisan bill is to reduce the amount of time that it takes FDA to approve new drugs, from about 31 months to 10 months. It would also level the playing field between U.S. manufacturers and overseas producers by making overseas suppliers subject to inspection practices similar to those FDA uses in the U.S.
EXPLOSION AT CHEMICAL PLANT IN CHINA KILLS 16
An explosion at Hebei Keeper Chemical Industries Co.’s (Shijiazhuang, Hebei Province, China) production facility at Zhaoxian county in Hebei Province, on February 28, killed at least 16 and injured more than 40 employees, say press reports. Several employees are also missing. The explosion flattened a part of the plant. Hebei Keeper Chemical mainly produces pharmaceutical intermediates and agchems. The exact cause of the incident is unclear.
ASAHI KASEI BUILDS ACETONITRILE PLANT IN KOREA
Asahi Kasei Chemicals (AKC), an Asahi Kasei subsidiary, says it will construct a new acetonitrile plant at Ulsan, Korea. The plant will have a production capacity of 11,000 m.t./year, and is expected to start production in January 2014. Construction of the plant will begin this month. Acetonitrile is mainly used as a solvent in the manufacture of pharmaceuticals, as an analytical reagent, as well as in agchems, Asahi says. A second production base for acetonitrile, in addition to the company’s plant at Kawasaki, Kanagawa Prefecture, Japan, will ensure AKC a reliable supply of acetonitrile as demand continues to grow rapidly worldwide, Asahi says. Acetonitrile is produced by refining crude acetonitrile, a byproduct of acrylonitrile. Strong growth in demand for acetonitrile is expected, particularly for use in pharmaceuticals, Asahi says.
WHO JOINS COLLABORATION ON INTERNATIONAL PHARMA PLANT INSPECTION PROGRAM
By Alex Scott
The World Health Organization (WHO; Geneva) has joined the U.S. FDA, the European Medicines Agency (EMA; London), the European Directorate of the Quality of Medicines and Healthcare (EDQM; Strasbourg, France), and the Australian Therapeutic Goods Administration (TGA; Canberra) in an international collaboration promoting the inspection of manufacturers of active pharmaceutical ingredients (API) around the world.
BASF APPOINTS CONNELL BROTHERS TO DISTRIBUTE EXCIPIENTS IN AUSTRALIA AND NEW ZEALAND
BASF says it has appointed Connell Brothers Australasia to distribute pharmaceutical excipients and human nutrition ingredients in Australia and New Zealand. The new distribution agreement covers the market segments food, beverages, as well as pharmacopoeia-certified excipients for dietary supplements. Connell Brothers currently has similar distribution agreements with BASF in Malaysia, Philippines and Singapore.
PFIZER AND BIOCON CALL OFF $350-MILLION DEAL
Pfizer and biotechnology company Biocon (Bangalore, India) say they have concluded their alliance to commercialize Biocon’s biosimilar versions of insulin and insulin analog products. Due to the individual priorities of their respective biosimilars businesses, the companies say they have decided it is in their best interest to move forward independently. The $350-million deal between the two companies was signed in October 2010. On March 12, 2012, all rights licensed to Pfizer were reverted to Biocon, and all insulin distributed under the brand name Univia and Glarvia will now be commercially available from Biocon only, and will be exclusively manufactured, supplied, marketed and supported by Biocon.
“Pfizer continues to be dedicated to developing a broad portfolio of biosimilars medicines, including monoclonal antibodies and recombinant proteins products, both internally and through collaborations,” says Diem Nguyen, general manager/biosimilars at Pfizer. “In addition, we will continue to be active in our own research and business development efforts for diabetes.”
RANBAXY OPENS MANUFACTURING FACILITY IN MOROCCO
Ranbaxy Laboratories (Gurgaon, India) says its Ranbaxy Morocco (Casablanca) subsidiary has opened a new manufacturing facility at Casablanca. This allows the company to have a direct business presence in North Africa and to access the $1-billion pharmaceutical market in Morocco, Ranbaxy says. The Casablanca facility of is authorized to manufacture Ranbaxy products following an audit of the facility by Moroccan health authorities. The new manufacturing unit, in addition to servicing the Morocco market, will also supply to other African countries in the coming years. Ranbaxy has two other manufacturing facilities in Africa – one in Nigeria and the other in South Africa.