Pharma/Fine Chemicals Roundup – August 23
12:44 PM MDT | August 23, 2011 | By DEEPTI RAMESH
EVONIK CREATES HEALTH CARE BUSINESS
Evonik Industries says it will combine three operations into a newly created health care business. Evonik's custom manufacturing of active ingredients operations will be combined with the Rexim pharmaceutical amino acids unit and pharmaceutical polymers effective September 1, 2011. The new business will form part of the Health & Nutrition unit, headed by Reiner Beste. The move will help Evonik meet customer needs more effectively. "By concentrating our pharmaceutical activities in the health care business line, we enhance our performance in all three areas," Beste says. It will help develop partnerships with key customers, he says.
The health care business will be divided into three product lines: pharma polymers with the brands Eudragit and Resomer and will be managed by Thomas Riermeier; exclusive synthesis under the management of Klaus Stingl; and Rexim, which will be headed by Thomas Hermann. The pharma polymers portfolio includes acrylic copolymers, marketed under the Eudragit brand name; bioresorbable polylactic-co-glycolic acid copolymers, marketed under the Resomer brand name; as well as advanced formulation services for oral and parenteral dosage forms. The exclusive synthesis product line focuses on the manufacture of cGMP intermediates and patented active pharmaceutical ingredients (API) and high potency APIs for the pharma industry. The Rexim product line is a producer of amino acids, peptides, and amino acid derivatives.
ORCHID RESTARTS API PLANT IN INDIA
Orchid Chemicals & Pharmaceuticals (Chennai, India) says its cephalosporin active pharmaceutical ingredient (API) manufacturing facility at Alathur, in the state of Tamil Nadu, India, has been reopened and production activity has restarted. The API plant was shut last month after it received a closure notice from the Tamil Nadu pollution control board (TNPCB) citing non-compliance in the disposal of solid waste. “The Alathur API plant that had earlier received a closure notice from TNPCB has now been cleared and production will begin immediately,” Orchid says.
FDA, INDUSTRY REACH GENERIC DRUG FEE AGREEMENT
U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.
Through the program, companies would pay fees to give the FDA extra money to hire more staff and improve support systems in its drug review process. Some of the fees would pay for bulking up FDA inspection of U.S. and foreign manufacturing facilities.
The FDA and several industry groups met three times in July, according to meeting notes posted on the FDA's website, and agreed that the industry would fund the user-fee program in full starting in year one.
That would amount to $299 million a year or more, if adjusted for inflation, with some of the first-year money coming from a one-time payment by those companies whose drugs are pending review in FDA's application backlog.
With bigger revenues, the generic drug industry is becoming more willing to pay for faster approval of its products. It is also eager for the FDA to improve its inspections to avoid such scandals as the 2008 recall of blood thinning drug heparin after at least 149 people died from tainted ingredients tracked to China.
Similar to the other user-fee programs, Congress would have to give its approval before generic drug user fees are enacted.
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