Pharma/Fine Chemicals Roundup – September 27
7:12 AM MDT | September 27, 2011 | By DEEPTI RAMESH
FDA ISSUES WARNING LETTER TO API PLANT IN INDIA
The U.S. Food and Drug Administration (FDA) issued a warning letter earlier this month to the active pharmaceutical ingredient (API) manufacturing facility of Yag-Mag Labs (Hyderabad, India) located in Gaddapotharam Village, in the state of Andhra Pradesh, India, for deviating from current good manufacturing practice (cGMP). An FDA inspection from June 27, 2011 to July 2, 2011 at the API facility of Yag-Mag Labs identified significant deviations from cGMP for the manufacture of APIs, FDA says. Yag-Mag Labs responded on July 18, 2011 and the FDA says it has reviewed the response, and that the corrective actions taken by Yag-Mag Labs are not sufficient.
The cGMP violations for the manufacture of APIs at the site include failure to document the manufacturing operations at the time they are performed, failure to have API manufacturing facilities of appropriate design and construction suitable for their intended use, failure to have appropriate procedures or practices in place to prevent cross-contamination, failure to prepare, review, and approve documents related to the manufacture of APIs, in accordance with written procedures, failure to adequately control, process, analyze, and approve or reject raw materials and finished APIs, FDA says.
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 Yag-Mag Labs 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 Yag-Mag Labs into the U.S., FDA says.
Failure to promptly correct violations may also result in legal action without further notice including, without limitation, seizure and injunction, FDA says.
AMPAC FINE CHEMICALS APPOINTS NEW VICE PRESIDENT OF OPERATIONS
Ampac Fine Chemicals (AFC; Rancho Cordova, CA), a subsidiary of American Pacific (Las Vegas, NV), says that Terence Vollrath has joined AFC as vice president of Operations. Terence Vollrath has over 30 years of experience in the active pharmaceutical ingredient (API) manufacturing industry, and has held operational leadership positions with Cody Laboratories (Cody, WY), the former Aerojet Fine Chemicals business, and Abbott Laboratories (Abbott Park, IL).
“Terry brings significant operational knowledge and experience to AFC. His addition to our management team further solidifies our position as a leading manufacturer of custom small molecule APIs,” says Aslam Malik, president of AFC.
AFC has capabilities in process development, scale-up, and commercial production of APIs and registered intermediates for pharmaceutical and biotechnology customers.
CHINA NATIONAL BLUESTAR SUBSIDIARY ACQUIRES FRENCH FIRM
Feed additives company Adisseo (Antony, France), a subsidiary of China National BlueStar, says it has acquired 90% stake in Innov’ia (La Rochelle, France). Innov’ia, with its subsidiaries, is one of the leaders in Europe in the design and toll manufacturing of powders and granules for the food and feed industry, pharmaceutical, cosmetic, and fine chemical sectors, Adisseo says. Financial terms were not disclosed. Innov’ia employs about 110 people and recorded sales of €16 million ($22 million) in 2010.
Adisseo says that it has launched a voluntary repurchase offer for the Innov’ia shares that it does not own. The offer, which will be open from September 27, 2011 to October 31, 2011, gives Innov’ia shareholders the opportunity to sell their shares at a price of €6.67/share. Innov’ia shares are currently listed on the Euronext Paris Marché Libre.
If, at the end of the offer, Adisseo exceeds the threshold of 95% in the capital and voting rights of Innov’ia, it will request the delisting of the Innov’ia shares, Adisseo says.
Adisseo and Innov’ia have developed several partnerships related to animal nutrition additives over the past 15 years. In 2008, Innov’ia’s Innocaps subsidiary built its production unit in Adisseo’s site at Commentry, France.
“This acquisition perfectly fits with our external growth strategy, whose main targets are the continuous improvement of our products and services, as well as the acquisition of new technologies. It strengthens the Adisseo group’s expertise in the formulation of additives,” says Jean-Marc Dublanc, president of Adisseo.
Adisseo employs 1,300 people, has 3 research labs and 5 production facilities in France, Spain and the U.S., and the company had sales of over €1 billion in 2010
“This alliance with the Adisseo group, a long-standing partner, strengthens our existing collaboration in terms of research, development and industrial transfer,” says Pierre Buisson, CEO of Innov’ia.
BOEHRINGER INGELHEIM TO ENTER BIOSIMILARS BUSINESS
Boehringer Ingelheim (Ingelheim, Germany) says it will establish a new separate business for the development and commercialization of biosimilars.
Biosimilars are approved versions of innovator biopharmaceutical products introduced after patent expiry.
“We believe that biosimilars will become a major part of the biopharmaceutical market and will enable many more patients access to important medicines,” says Wolfram Carius, member of the board of managing directors and responsible for operations at Boehringer Ingelheim. The company will leverage its “capabilities in product development, supply and clinical expertise at Boehringer Ingelheim to offer high quality biosimilars understanding patients’ needs.”
Boehringer Ingelheim is one of the world’s leading pharmaceutical companies and it operates globally with 145 affiliates and more than 42,000 employees. Boehringer Ingelheim recorded sales of about €12.6 billion ($17 billion) in 2010. Boehringer Ingelheim also develops and manufactures biopharmaceutical therapeutics, and Boehringer Ingelheim Biopharmaceuticals is currently one of the leading companies in this field.
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