Ingredients

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

The Society for Chemical Manufacturers & Affiliates commented on EPA's modifications to the Inventory Update Reporting rule, also broadly know as the Chemical Data Reporting rule. EPA issued the final rule earlier this month.

Merck & Co. announced last week that it plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company made the announcement as part of its second-quarter earnings release, which the company issued on July 29, 2011.

Contract manufacturing organizations throughout Asia are increasing their capabilities to meet market demand and attract foreign investment and partnerships.

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

China rises to the top as a destination for international outsourcing.

A path to personalized medicines creates a new paradigm for development and manufacturing.

The article examines a cross-functional supplier integration model to facilitate project management.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

The DHS announced it has revised tiering assignments for several chemical facilities covered under DHS's Chemical Facility Anti-Terrorism Standards program, which requires chemical companies to develop and implement specific security plans for their facilities.

SOCMA has issued its support this week of the passage of pending free-trade agreements with South Korea, Panama, and Colombia by two Congressional committees.

FDA, in cooperation with IPEC, is building a spectral library of excipients to detect improper ingredients within a drug product on site.

The performance of biotechnology venture capital and investment is lackluster at best.

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

Better strategies and practices in sourcing and procurement can contribute to the bottom line.

The authors investigate the influence of hydro-alcoholic media on hydration and drug release from polyethylene oxide extended-release matrices.

The current review describes the role and selection of excipients, pellet core, coating materials, and compression with various cushioning agents.

The IPEC Federation has issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan.

Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Listen to roundtables from the 2011 ExcipientFest/IPEC conference, addressing developing issues in excipient functionality and continuous manufacturing.

The study results suggested that Pluronic F127 might be a potent inhibitor of drug precipitation for Labrasol formulations.

India's drug pricing authority increased the retail costs of certain domestically manufactured drugs, but not those of imported drug products. Pharma is asking why.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

Takeda Pharmaceutical has agreed to acquire Nycomed, a Swiss pharmaceutical company for $13.5 billion, excluding Nycomed's US dermatology business. The deal is intended to increase Takeda's presence in European and emerging markets.

The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.