Archive for the 'Ingredients' Category

Some Recalled Infants’ Tylenol Had Too Much Acetaminophen

Alexis Brekke Pellek PharmTech editorThe Wall Street Journal reported yesterday that some of McNeil Consumer Healthcare’s recalled infants’ Tylenol contained as much as 24% more acetaminophen than it should have, according to a letter the company sent to physicians and poison-control personnel. McNeil’s letter stated that the samples containing the 24% increase did not reach the public, but that the company could not be sure “all the individual bottles were within specification or that 24% would have been the maximum,” according to WSJ. Read more »

Pharma Companies and Suppliers Meet at DCAT Week

Patricia Van Arnum PharmTech editor Sourcing, procurement, and supply-chain professionals from the pharmaceutical industry and their suppliers are gathering this week in New York City at DCAT Week, an annual event of educational programs and business-networking opportunities organized by the Drug, Chemical and Associated Technologies Association. (DCAT). The first day of the event kicked off on Monday with an educational program addressing the impact of changing market fundamentals on innovator-drug and generic-drug companies. Read more »

Rx-360 Goals Get off the Ground

Angie Drakulich PharmTech editorMany companies throughout industry are depending on Rx-360, the international pharmaceutical supply-chain consortium launched last year, to help ease the burden of protecting their ever-lengthening supply chains. Read more »

Cautious Optimism Prevails at CPhI in Madrid

Patricia Van Arnum PharmTech editor What is the outlook for contract manufacturing of active pharmaceutical ingredients and intermediates? In gaining feedback from exhibitors and attendees at CPhI Worldwide, the large exhibition and conference of pharmaceutical ingredients, which was held in Madrid last week, the prevailing sentiment was one of cautious optimism. Most said business conditions have improved since the financial crisis began in September 2008, but that the level of outsourcing has not returned to levels reached before the start of the economic downturn. Read more »

IPEC Regulatory Conference Coverage: More Calls to Action

Angie Drakulich PharmTech editorIPEC-Americas Chair Janeen Skutnik continued the call for more standards and regulation for the pharmaceutical excipients industry at yesterday’s IPEC Regulatory Conference afternoon session. “We’re not the Rodney Dangerfields of industry anymore,” she said, playing on the fact that many feel excipients are somehow a “lesser” part of the pharma industry because they’re “inactive” drug ingredients. “We need to work with Congress and regulators to put in place the right standards,” she said. Read more »

IPEC Regulatory Conference Coverage: We Want to be Regulated, Says Excipient Industry

Angie Drakulich PharmTech editor“We want to be regulated.” That seems to be the theme thus far at the IPEC Regulatory Conference, taking place today and tomorrow in Washington, DC. The morning session opened with IPEC Chair Janeen Skutnik talking about how busy the past year has been for the excipient industry and for IPEC itself. With work being done on pedigrees, functionality, GMPS, and GDPS, excipients are taking on all sorts of new lives. Read more »

Putting Teeth into Being Green

Patricia Van Arnum PharmTech editor An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway. The move is a helpful step toward more sustainable practices for the chemical and pharmaceutical industries, but it raises larger questions. Can the pharmaceutical industry be more proactive in becoming green? And can regulatory authorities do more to encourage process improvement for green pharmaceutical manufacturing? Read more »

How Green is Pharma?

Patricia Van Arnum PharmTech editor One measure of changing public focus is when words become part of our common lexicon. The addition of “carbon footprint” and “green collar” to the latest edition of the Merriam Webster dictionary, released last month, reflects not only the acceptance of “greenspeak” in our communication, but more importantly its integration into mainstream activities. That sentiment was evident at the Green Pharma Summit, which was held last month in Philadelphia, where pharmaceutical and government officials shared their involvement in sustainability practices for pharmaceutical manufacturing and drug-product life-cycle management. Read more »

Collaborative Business Models a Key Focus at ExcipientFest

Patricia Van Arnum PharmTech editor Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients. Read more »

Biologics: A Gamble or Safe Bet?

Patricia Van Arnum PharmTech editorPfizer announced this week that following a successful completion of its $68-billion acquisition of Wyeth, it will divide its research activities into two separate organizations, one for small molecules and one for biologics and vaccines. The reorganization is but a microcosm of Big Pharma’s larger strategic interest to strengthen its position in biologics with the hopes of improving its return on research and development (R&D). But is the calculus of intensifying R&D into biologics correct? Read more »

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