Ingredients

The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency's (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA).

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

Pharmaceutical Technology gains insight into approaches for producing aromatic amines.

New data provide insight into pharma-industry professionals' daily lives.

The current trend in the pharmaceutical industry for the manufacture of small-molecule therapeutic agents is moving toward continuous flow processes. This article is part of a special issue on APIs.

The author presents recent developments in simulated moving-bed chromatography in production of active pharmaceutical ingredients and intermediates. This article is part of a special issue on APIs.

The author explains the background behind the excipient pedigree and how to implement its use.

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

The authors discuss the capabilities of immobilization technologies and the ability to use an expanded range of solvents for mobile-phase components and solvent dissolutions. This article is part of a special issue on APIs.

The authors describe several examples of using asymmetric hydrogenation and biocatalysis for synthesizing several secondary alcohol compounds.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Chemocatalytic and biocatalytic approaches in asymmetric synthesis help provide a pathway for producing single-enantiomer drugs.

Green chemistry in pharmaceutical development often centers around approaches in the synthesis of the active ingredient, but green-chemistry techniques also can be applied to drug-product manufacturing, formulation development, and drug delivery.

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

The Society of Chemical Manufacturers and Affiliates (SOCMA) expressed "strong concern" over legislation introduced in the US Senate earlier this month regarding chemical-site security.

Merck KGaA (Darmstadt, Germany), a global pharmaceutical and chemical company, completed its acquisition of Millipore (Billerica, MA), a life-science company, last Thursday for an aggregate purchase price of roughly EUR 5.2 billion ($6.7 billion).

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.