in this issue
Pharma/Fine Chemicals Roundup – September 20
September 20, 2011 | By DEEPTI RAMESH
FDA ISSUES WARNING LETTER TO LONZA PLANT IN U.S.
The U.S. Food and Drug Administration (FDA) issued a warning letter earlier this month to Lonza’s manufacturing plant at Hopkinton, MA, for deviating from current good manufacturing practice (cGMP). An FDA inspection from April 4, 2011 to May 6, 2011 at Lonza’s pharmaceutical and active pharmaceutical ingredient (API) manufacturing facility at Hopkinton identified significant violations of cGMP regulations for finished pharmaceuticals, and from cGMP for the manufacture of APIs, FDA says. Lonza responded on May 26, 2011 and the FDA says it has reviewed the response, and that the corrective actions taken by Lonza are not sufficient.
The cGMP violations for the manufacture of APIs at the site include inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards; failure to validate analytical test methods used for API for potency testing; and failure of the company’s quality unit to exercise its responsibility to ensure that APIs manufactured are in compliance with cGMP, including meeting established specifications for quality and purity, FDA says.
Lonza must investigate and determine the causes of the violations identified in the warning letter and prevent their recurrence and the occurrence of other violations, FDA says. Prompt action must be taken by Lonza to correct the violations cited in the letter, and failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction, FDA says. FDA may also withhold approval of requests for export certificates, or approval of pending drug applications listing this Lonza facility, until the above violations are corrected, FDA says. FDA says it may re-inspect the facility to verify corrective actions have been completed.
SOCMA SUPPORTS FDA AGREEMENT TO ESTABLISH INSPECTION PARITY
The Society of Chemical Manufacturers and Affiliates (Socma) says its bulk pharmaceutical task force (BPTF) has concluded its work with the FDA and agreed to a proposal for the generic drug user fee program (GDUFA) designed to level the playing field between foreign and domestic manufacturing facilities inspected by the agency. The Generic Pharmaceutical Association (GPhA) and the European Fine Chemicals Group (EFCG) also participated in the talks, and BPTF worked with EFCG to present the views of active pharmaceutical ingredient (API) manufacturers.
BPTF, an industry trade group for manufacturers of APIs, has been in talks with the FDA since February, working towards a nearly $300 million deal that would result in greater scrutiny of drug manufacturing in ‘high-risk’ regions of the globe. Together with the GPhA and the EFCG, BPTF has ratified the FDA proposal, which includes a long-standing goal of conducting risk-based inspections of all foreign and domestic generic drug manufacturers and obtaining timely approvals for generic drugs.
“U.S. manufacturers are in an unfair situation seeing strong FDA oversight and enforcement, where some foreign sites have little or no oversight. This agreement will lead to parity and will go a long way in preventing deaths and illness associated with contaminated or counterfeit drugs,” says BPTF Chair Patty Benson, quality assurance director at SAFC.
U.S. manufacturing facilities are currently inspected every two years as mandated by Congress, but many foreign drug manufacturing facilities have never been inspected.
The ratified agreement, along with proposed legislative language, is currently pending within the department of health and human services, and will be provided to the office of management and budget for review thereafter. FDA anticipates providing a generic drug user fee package to Congress in January, which could lead to legislative changes including fees to better protect public safety and health. The lack of parity, potential funding/resource issues for the FDA and globalization of APIs continue to pose significant risks to U.S. consumers. BPTF believes this could be a significant step toward a safer drug supply.
LONZA TO LIST ON SINGAPORE STOCK EXCHANGE
Lonza says it has submitted an application for a secondary listing by way of an introduction on the main board of the Singapore Exchange Securities Trading Limited. The actual listing and the first trading day is expected to occur in the fourth quarter of 2011. The proposed secondary listing is expected to make Lonza the first SIX Swiss-listed company to have a dual listing in Singapore. SIX Swiss Exchange (Zurich) is Switzerland's principal stock exchange.
“We already have a strong presence across a large footprint in Asia and this secondary listing signals Lonza’s long-term commitment to the region, further strengthening our position to tap opportunities in the fastest growing economies in the world,” says Stefan Borgas, CEO of Lonza. “This strategic move to list in Singapore enables us to have a more visible presence in Asia, in addition to allowing us to tap the strong capital flows in Asia, while enlarging and broadening our current investor base in the region.”