Ingredients

Pfizer uses green-chemistry in a second-generation manufacturing route for gabapentin.

As new process validation guidelines emerge, industry needs to reinvent how it releases product.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

The authors discuss the advantages of microreactors and flow chemistry for various reaction types in achieving improved process economics and reaction efficiency.

Scientists from DSM and Kaneka discuss various techniques in this roundtable moderated by Patricia Van Arnum.

The authors describe the various available technologies used in orally disintegrating tablets.

Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...

Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...

An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway.

Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more...

Manufacturing methods for new drugs could be made greener and more efficient with the help of marine microbes.

Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...

Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported in late July that Eurostat, the Statistical Office of the European Communities, recently published a baseline study or the first snapshot of REACH policy in the preregistration phase.

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

Biologics enhance their positions amidst slowing growth in the global and US markets.

Brief pharmaceutical news items for August 2009.

Biotech firms must first close the gaps between science and biology on the path toward QbD.

Individuals and companies at the top seem to have no problem short-circuiting their success.

Leading contract manufacturing organizations share their views on the current and future market dynamics shaping pharmaceutical outsourcing.

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...

Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...

The Society of Chemical Manufacturers and Affiliates (SOCMA) this week stated its support to the US Senate for approving legislation that would extend existing chemical security standards for one more year.

Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...

Johnson & Johnson has agreed to pay $1.0 billion to acquire the assets and rights of the Alzheimer's immunotherapy program of the biopharmaceutical company Elan, form a new company with Elan based on the AIP program, and gain an 18.4% stake in Elan.

Advances in micellar catalysis, solid-state chemistry, catalytic asymmetric synthesis, and function-oriented synthesis for natural products represent noteworthy developments in green chemistry that can be applied to the synthesis of active pharmaceutical ingredients.

Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more...

This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines.

REMS to improve the safe use of opioids may lead to controls on other high-risk medicines.