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Pharma/Fine Chemicals Roundup – December 13
6:36 AM MST | December 13, 2011 | By DEEPTI RAMESH
CPHI INDIA: EVONIK AIMS TO BECOME A LEADER IN HPAPIS
Evonik Industries, which created a healthcare business line on September 1, plans to become a leading provider of highly potent active pharmaceutical ingredients (HPAPIs), Thomas Riermeier, v.p./Pharma Polymers product line, and Axel Bergt, v.p./sales and services Asia, Healthcare at Evonik told CW at the CPhI India exhibition at Mumbai, earlier this month. The company announced last month that it has expanded the production capacity for HPAPIs on a kilogram scale at its Tippecanoe Laboratories (Lafayette, IN) site. Evonik has also set up a new laboratory for HPAPIs at Hanau, Germany.
“The size of Evonik’s HPAPI manufacturing capacity and the 20 years of experience in the production of HPAPIs at Lafayette would propel the company to a leading position in this business,” Bergt says.
Evonik acquired Tippecanoe Laboratories from Eli Lilly in January 2010. At the Tippecanoe Laboratories site, Evonik has a total of 170 m3 of reactor capacity for the manufacturing of HPAPIs consisting of 135 m3 for multi-ton scale production and 35 m3 for small and development quantities. The Lafayette site employs about 650 people.
DISTRIBUTOR IMCD ACQUIRES IN ITALY
By Ian Young
IMCD Italia (Milan), a subsidiary of chemical distributor IMCD Group (Rotterdam), has agreed to acquire the fine chemicals distribution business in Italy of Organotec (Burago di Molgora, Italy). The acquired business will be fully integrated into IMCD Italia in January 2012, IMCD says.
"Organotec is a reputable player in the fine chemicals market in Italy and its portfolio perfectly complements ours in Italy," says Gabriele Bonomi, managing director at IMCD Italia. "Our expertise and network in other markets open up possibilities for Organotec's principals to enter new market sectors." IMCD says it is the biggest distributor of specialty pharmaceutical ingredients.
FDA ISSUES WARNING LETTER AND IMPORT ALERT ON AKZONOBEL’S API PLANT IN MEXICO
The U.S. Food and Drug Administration (FDA) issued a warning letter last month to Akzo Nobel Chemicals’ (Los Reyes La Paz, Mexico) manufacturing plant at Los Reyes La Paz, for deviating from current good manufacturing practice (cGMP). An FDA inspection in June 2011 at the AkzoNobel active pharmaceutical ingredient (API) manufacturing facility at Los Reyes La Paz identified significant deviations from cGMP for the manufacture of APIs, FDA says. AkzoNobel responded on July 11, 2011 and the FDA says it has reviewed the response, and that the corrective actions taken by AkzoNobel are not sufficient. Until all corrections have been completed and FDA has confirmed corrections of the deviations and compliance with cGMP, FDA may withhold approval of any new applications or supplements listing Akzo Nobel Chemicals, as an API manufacturer, and the company will remain under FDA Import Alert and FDA will continue to refuse admission of all articles manufactured at Akzo Nobel Chemicals, into the U.S., FDA says.
CHINA APPROVES PLAN TO STRENGTHEN DRUG SAFETY
The Chinese government says that the State Council (Beijing), the country’s cabinet, has approved a plan to establish a credit rating system and to intensify monitoring of pharmaceutical companies over the next five years, in an effort to crack down on drug safety. The State Council approved the plan in an executive meeting on December 7, presided over by premier Wen Jiabao. The plan aims to significantly increase the level of drug safety by ensuring all pharmaceutical products meet the standards of a newly revised regulation on the quality management of medical products by the end of 2015.