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Greenstone Healthcare Solutions

Division of Pfizer Inc.

Latest From Greenstone Healthcare Solutions

Pfizer/Mylan: Pending Clash Of Quality Systems Could Determine Fate Of New Firm

After years of Mylan’s “one quality standard,” the merger with Pfizer Upjohn brings another. Which will prevail? Which should prevail?

Manufacturing Quality

Celebrex Generic Exclusivity Suit Could Have Broad Financial, Regulatory Reach

Appeals court says FDA violated Hatch-Waxman by awarding 180-day exclusivity solely to Teva based on reissued patent; celecoxib generics are already marketed but could step out from Pfizer-authorized status.

BioPharmaceutical United States

Drug Recalls Soared Again in 2013, Driven by Contamination

FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.

Manufacturing Quality

Chief Executive Change At Teva Illustrates Diversification Emphasis At Major Generic Drug Makers

Most of the top 20 generic drug makers are subsidiaries of diversified pharmas or smaller generics-only plays based in the Far East. But diversification, although long a goal, is now urgent for the three major independent generic firms – Teva, Mylan and Watson.

BioPharmaceutical Europe
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