IHS Chemical Week


Pharma/fine chemicals roundup—25 June 2013

8:55 PM MDT | June 25, 2013 | By DEEPTI RAMESH

Socma welcomes waiver for US API exports to Europe

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of Socma, hailed an announcement from European officials granting US drug makers an exemption from new export requirements, thereby ensuring a continued supply of safe drugs into the European Union from the United States, Socma says. The European Union has reformed the rules for importing active pharmaceutical ingredients (APIs) for medicinal products for human use. The new EU standards and regulations will become effective on 2 July. According to new requirements, all imported APIs must have been manufactured in compliance with cGMP standards equivalent to EU cGMP. Being listed by the European Commission or issuing a written confirmation are two possible options introduced by the European Union’s new directive. The compliance must be confirmed in writing by the competent authority of the exporting country. Industry experts had predicted that the European Union could face drug shortages if the United States was not granted exemption from the new requirements. “We are pleased that US drug manufacturers will not be required to provide written confirmation of quality for the exportation of active pharmaceutical ingredients into the EU,” says John DiLoreto, executive director of BPTF.

FDA issues warning letter to RPG Life Sciences API plant in India

FDA issued a warning letter late last month to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facilities of RPG Life Sciences (Mumbai)—located at Navi Mumbai and Ankleshwar, India, respectively—for violations of cGMP. The warning letter was recently published on the FDA Web site. An FDA inspection, from 28–31 January 2013 at the Navi Mumbai API facility and from 20–24 November 2012 at the Ankleshwar finished pharmaceuticals facility, identified significant deviations from cGMP for the manufacture of APIs and the violation of cGMP regulations for finished pharmaceuticals, FDA says. The violations for at the Navi Mumbai site include the failures to investigate and document out-of-specification results according to a procedure, to adequately investigate all quality-related complaints, and to establish and exercise adequate controls over computers to prevent unauthorized access or changes to electronic data, FDA says.

AMRI Burlington receives DEA approval to handle controlled substances

Albany Molecular Research Inc. (AMRI; Albany, NY) says that its Burlington, MA, site has received approval to expand its current US Drug Enforcement Administration (DEA) registration to handle Schedule II and Schedule II nonnarcotic controlled substances. With its cGMP aseptic formulation and filling expertise, AMRI Burlington supports preclinical through commercial scale production of liquid-filled and lyophilized parenterals. The addition of Schedule II compounds to this registration allows Burlington to perform controlled substance work for its customers, both in the laboratory and on the engineering/production side. In DEA terms, Burlington is considered a dosage-form manufacturer, and this expanded registration will allow Burlington to offer filling services for schedules II, II nonnarcotic, III, III nonnarcotic, IV, and V controlled substances, as well as offer these services to complement more of the projects handled by AMRI’s Rensselaer, NY, site. AMRI’s Rensselaer site—which provides contract cGMP manufacturing of bulk active pharmaceuticals and advanced intermediates—holds a DEA controlled substance license permitting the manufacture of schedules I–V controlled substances.

Aceto names Rising Pharmaceuticals president and COO

Fine chemicals distributor Aceto says that Satish Srinivasan was appointed as president and COO of Aceto’s Rising Pharmaceuticals (Allendale, NJ) subsidiary, effective 15 July. Srinivasan has nearly 20 years of experience in the generic pharmaceutical industry, all with Orchid Chemicals & Pharmaceuticals (Chennai, India). He has held various business development, operating, and management roles, serving most recently as the president and CEO of Orchid Pharma and Orgenus Pharma, the US subsidiaries of Orchid, which is a vertically integrated company spanning the entire pharmaceutical value chain, from discovery to marketing.

University of Liverpool obtains funding to develop next-generation biobased chemicals

The University of Liverpool (Liverpool, UK) has been awarded funding to help develop the next generation of renewable chemicals from biomass, for use in the manufacture of materials, plastics, solvents, and pharmaceuticals. The £1.8-million ($2.8 million) project, which is a collaboration with the University of York (York, UK), will involve developing platform chemicals from the sugars, fats, oils, and carbohydrates produced by biomass, including food supply chain wastes and forestry wastes. "This project brings together academia and industry experts from the fields of materials chemistry, biorefineries, catalysis, and chemical synthesis to address some of the challenges of converting biomass materials into new, high-value chemical products. The combined expertise of the University of Liverpool in the discovery and development of new advanced materials for catalytic transformations of biomass, with expertise from the University of York in biomass transformations, will be paramount to the success and applicability of this project," says José Lopez-Sánchez, lecturer/sustainable chemistry and catalysis at the University of Liverpool and who is leading the project.

AstraZeneca to build new global R&D center and corporate headquarters at Cambridge, UK

AstraZeneca (London) says its new UK-based global R&D center and corporate headquarters will be located at the Cambridge Biomedical Campus, on the southern outskirts of Cambridge. By 2016, the new site will house a workforce of about 2,000. The investment in a £330-million ($508 million) facility in Cambridge is part of the company’s move to create strategic global R&D centers in the United Kingdom, United States, and Sweden to improve pipeline productivity and to establish AstraZeneca as a global leader in biopharmaceutical innovation, the company says.

Beyond IHS Chemical Week:

Dishman Pharma's Saudi plans yet to take off
from Business Standard, India

Dishman Pharmaceuticals and Chemicals’ Saudi plans have yet to take off. While the company's bulk-drug API-making joint venture is expected to start production next month—after almost a three-year delay—the company's 50-50 jv with Takamal to make disinfectants has been called off.

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