Week of Mar. 19, 2012: FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More - Pharmaceutical Technology

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Week of Mar. 19, 2012: FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issued a Warning Letter to the specialty-pharmaceutical company Warner Chilcott for GMP violations determined from a June 22–July 29, 2011 inspection of the company’s Fajardo, Puerto Rico, manufacturing facility. FDA cited Warner Chilcott for the following specific violations, which were determined as inadequately addressed from an Aug. 18, 2011, company response:

  • “Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 CFR § 211.192].”
  • “Your firm has failed to ensure that your quality control unit fulfills its responsibilities as required by [21 CFR § 211.22(a)].” Read More

GlaxoSmithKline (GSK) has agreed to divest its noncore OTC brands in Europe to the Belgian healthcare company Omega Pharma for EUR 470 million ($621.9 million) in cash. The brands being divested include Lactacyd, Abtei, Solpadeine, Zantac, Nytol, and Beconase, and generated sales of approximately £185 million in 2011 ($293.3 million). It is expected the divestment will be completed in the second quarter of 2012, subject to regulatory approvals. The net cash proceeds from the transaction are expected to be approximately £310 million ($491.5 million), which will be returned to shareholders during 2012. As part of the agreement, Omega will be acquiring the Herrenberg, Germany, manufacturing site which employs approximately 110 people. A number of the brands that are being divested are manufactured at Herrenberg, and it is anticipated that existing employees will transfer with the site to Omega Pharma under the provisions of German employment law. Read More

Merck & Co. has agreed to create the California Institute for Biomedical Research (Calibr). Calibr, an independent, nonprofit organization to be led by Peter G. Schultz, will offer academic scientists a streamlined, efficient, and flexible path for translating biomedical research into medicines. Merck will provide funding to Calibr of up to $90 million during a period of seven years and has an option to obtain an exclusive commercial license to any proteins or small-molecule therapeutic candidates derived from work conducted by Calibr. Read More

Sigma-Aldrich has opened a new facility in Wuxi, China, which will provide localized packaging, analytical services, and quality control for high-quality products to support the company’s research and industrial customers in the region. The new facility sits on approximately 20 acres of land and includes a dedicated quality control center, an analytical application laboratory, and a packaging building. Read More

Sigma-Aldrich has also recently completed a 57,000-ft2 expansion of its Bangalore, India, campus. The new addition features approximately 49,000 ft2 of distribution space and 8000-ft2 of packaging space. The existing 10-acre campus will continue to house the administrative offices, sales, marketing, and distribution functions, as well as manufacturing. Read More

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More


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