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New Ranbaxy Site in India Begins Shipping Generic Lipitor to the US

Ranbaxy Laboratories announced in early April that the company has begun exporting its generic version of Lipitor (atorvastatin calcium) oral tablets to the US market from its new “Mohali” manufacturing facility located in Punjab, India. In the first quarter of 2012, the company received approval from FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg […]

Genzyme Viral Contamination Lessons Implemented in New Biotech Plant; Virus Control Draws Agency/Industry Dialogue

FDA’s and EMA’s January inspection clearance of Genzyme’s new production facility in Framingham, Massachusetts marks another significant step in the firm’s recovery process from a viral contamination and GMP compliance problems cited in a consent decree....

GMP Consent Decrees Do Not Delimit Litigation and Financial Risks, Skadden, Arps Partner Stresses at FDLI Conference

Consent decrees provide a resolution between FDA and a pharmaceutical manufacturer of the cGMP compliance commitments and non-conformance penalties but do not forestall other types of litigation and generally have a long tail of related liabilities and financial repercussions, Skadden, Arps, Slate, Meagher & Flom Partner Jennifer Bragg stressed at the annual Food & Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference in Washington, D.C. in December....

Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity

The consent decree signed between Indian generic drug manufacturer Ranbaxy and the US Department of Justice (DoJ) serves as a warning shot across the bow for companies supplying to the US market that FDA findings of falsified information in applications or CGMP records will have very substantial consequences....

J&J Board Report Explores Causes of McNeil’s Compliance Breakdowns

A report on an inquiry by a committee of J&J board members into the firm’s recent compliance problems provides insights into how staff reduction, acquisition integration, and communication gaps between operations, company management and the board can contribute to compliance breakdowns in a big pharma organization....

McNeil Consent Decree Reflects Previous Big Pharma Injunctions Minus Disgorgement

The consent decree signed between McNeil and the U.S. Department of Justice on March 10 covering its Fort Washington, Lancaster and Las Piedras facilities contains the standard CGMP injunction provisions for independent expert consultant oversight and monetary penalties if the specified remediation timetables are not met. However, it does not include the large “disgorgement” fines characteristic of similar big pharma injunctions over the past decade....

Deltex Injunction Follows History of Lab GMP and Unapproved Drug Compliance Problems

An injunction against Texas-based prescription and over-the-counter (OTC) drug contract manufacturer Deltex is forcing the firm to shut down operations and recall all products manufactured since it received an FDA warning letter in 2008....

Genzyme Allston Plant Resumes Normal Operations Although Shortages Continue

In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market....

Genzyme Consent Decree Results in $175 Million Fine, Drug Shortages Will Continue

Genzyme’s consent decree for GMP violations at its Allston, Massachucetts plant will require it to pay a $175 million “disgorgement fee” and bring the plant back into compliance with applicable regulations within a specified time frame, during which time shortages of several of its drugs will continue. The consent decree was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010, and is subject to court approval....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]
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