Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures

22-May-2013 - Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.

Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing

21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.

News in brief

Hikma is Latest Firm to Stop Drugs Being Sold for Lethal Injections

20-May-2013 - Hikma has become the latest injectable manufacturer to take measures to stop its drugs being used in lethal injections.

Janssen's Manufacturing Problems May Lead to Criminal Charges in Korea

20-May-2013 - Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.

US House Committee Advances Track-and-Trace Legislation

16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.

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.

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 .

Pfizer Sells On-Line to Dampen Fake Viagra's Rise

07-May-2013 - Pfizer has begun selling Viagra online in order to counter the trade in fake versions of its erectile dysfunction drug.

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.

US FDA, USP Look to Ghana for Pilot Testing of Antimalarial Counterfeit Detector

06-May-2013 - A push to root out antimalarial counterfeit drugs in Ghana will begin later this year or early 2014 as part of a pilot project to test an FDA-developed counterfeit detector.

Hospira says Troubled Plant on 'Rocky' Road to Recovery

06-May-2013 - Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.

Dispatches from Excipient Fest in Baltimore

Brazil’s Anvisa to Publish Revised Excipient GMP Guideline

06-May-2013 - Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.  

Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

02-May-2013 - As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.

Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

02-May-2013 - China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.

Drug Industry gathers for Interphex 2013 - Check for live updates

23-Apr-2013 - Pharmaceutical conferences are like buses - to paraphrase an old British joke - you wait for one and then three come along at once.

Avoiding Cross-Contamination in Antibiotic Manfacturing, the FDA Way

23-Apr-2013 - The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.

Prof Says Knowing How to Handle Dangerous Reagents is Key

22-Apr-2013 - The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.

EMA Updates Database with GMP Data to Strengthen Supply Chain Safety

22-Apr-2013 - The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.

Chinese Drugmakers Still Suffering from Chromium Capsule Scandal

17-Apr-2013 - Biostar Pharmaceuticals has blamed end-of-year losses on last year’s chromium-tainted gelatin scandal though it is slowly recovering following a suspension of sales enforced by the SFDA.