Breaking News on Global Pharmaceutical Technology & Manufacturing

Ingredients: Top Headlines

Pfizer Takes Issue with European Commission’s Plans to Regulate ATMPs

23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).

Related news

Pfizer Puts Lipitor Site Up For Sale as Patent Expiration Causes Over-Capacity

16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years. 

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.

Aesica Accesses Atom-Efficient Amide Tech in Academic Accord

14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.

Canada Solidifies GMP Requirements for APIs to Secure Supply Chain

14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette .

Large Scale Manufacturing Drives AMRI Q1 Revenue Uptick

14-May-2013 - Large scale manufacturing revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue. 

EMA Seeks to Revise Some Phthalate Limits in Excipients

08-May-2013 - The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline .

FDA Releases Alexion Response to Form 483 on Microbial Contaminations

07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.

Ingredients: Featured news

Spotlight

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients
Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...

China Looks to Tighten Excipient Regulations with Limited Resources
Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have...

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...