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ePT--the Electronic Newsletter of Pharmaceutical Technology

Ranbaxy Laboratories has gained approvals from the US Food and Drug Administation to manufacture and market galantamine hydrobromide tablets and carvedilol tablets.

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PTSM: Pharmaceutical Technology Sourcing and Management

Purchase-order contracting is a commonly used approach to conducting commercial transactions, but it is a risky proposition when applied to pharmaceutical transactions, including the buying and selling of contract services and pharmaceutical ingredients. The authors examine the contract provisions covered in a commercial-supply agreement that are likely to be omitted under purchase-order contracting and the risk-reduction benefits that a commercial-supply agreement can offer in pharmaceutical procurement transactions.

PTSM: Pharmaceutical Technology Sourcing and Management

Aptuit expands its drug-development capabilities with the formation of Aptuit Laurus to take advantage of the growing pharmaceutical outsourcing market in India.

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A Call for FDA Inspections

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

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Self-destruction

Poor processing and misguided projections lead to trashed product.

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When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.

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US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines

ePT--the Electronic Newsletter of Pharmaceutical Technology

Pfizer (New York) proceeded with two agreements this week: a drug-development deal with Bristol-Myers Squibb (New York) and a license agreement with Xoma (Berkeley, CA) for antibody technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during a television prescription drug advertisement.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The biopharmaceutical company Biopartners recently published data that showed its biosimilar "Valtropin" (somatropin), a recombinant human-growth hormone product, demonstrated the same safety and efficacy as Eli Lilly’s "Humatrope" in children with growth hormone deficiency.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Icagen signed a worldwide collaboration and licensing agreement with Pfizer for the discovery, development, and commercialization of compounds that modulate three specific sodium ion channels and could provide treatments for pain and related disorders.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Senator Chuck Grassley (R-IA), a ranking member of the Senate Committee on Finance, asked the US Food and Drug Administration to explain what steps it is taking to ensure the safety of medicine manufactured outside the United States.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Schering-Plough announced today that a consent decree filed against the company in May, 2002, had been dissolved by the US District Court for the District of New Jersey in Newark.