31-Jan-2014 - Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.
30-Jan-2014 - CordenPharma has received certification of Potent Compound Safety at a US plant and joins a growing list of drugmakers looking to assure HPAPI safety, according to SafeBridge Consultants.
27-Jan-2014 - Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.
23-Jan-2014 - Increased in-house API production and manufacturing in India will lower the costs of Hospira’s injectables, the firm says, as it looks past current remediation efforts.
16-Jan-2014 - GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.
15-Jan-2014 - The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.
15-Jan-2014 - Genentech has resolved the issues that earned its Herceptin API plant in Vacaville, California a Form 483 from the US FDA last year.
13-Jan-2014 - Aurobindo has denied reports of a boiler blast at an Andhra Pradesh, India facility whilst Amgen is investigating an incident at its San Francisco R&D site.
13-Jan-2014 - An Indian API facility has received a form 483 from the US FDA in the latest setback for troubled drugmaker Ranbaxy.
08-Jan-2014 - The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.
08-Jan-2014 - Excipient production at a BASF plant in Lugwigshafen, Germany has been deemed to meet standards set out under the excipact certification scheme.
08-Jan-2014 - Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers.
06-Jan-2014 - Chinese API firm Shenzhen Hepalink has announced plans to buy Scientific Protein Laboratories (SPL) from private equity investor American Capital for $337.5m.
06-Jan-2014 - New GMP rules mean Kangtai Biological Products cannot restart production of a Hepatitis B vaccine wrongly linked to deaths even though authorities now deem it to be safe.
06-Jan-2014 - A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticised by the agency again following an inspection last month.
19-Dec-2013 - The EMA and US FDA will conduct joint site inspections and share the results of assessments of bioequivalence data for generic drugs under an accord announced last night.
17-Dec-2013 - Firms selling drugs in Brazil have three years to implement track and trace systems capable of monitoring drugs from the factory floor to the pharmacy under a new plan approved by Anvisa.
16-Dec-2013 - Novartis has recalled 37 batches of over-the-counter (OTC) cough syrup after its contract manufacturer, BCM, detected a fault on a packaging line at its UK plant.
12-Dec-2013 - Pharmacy chain Boots UK has expanded a recall of some own-brand drugs after detecting a fault in a manufacturing line that applies tamper evident seals.
12-Dec-2013 - The US FDA has cited failure to assure an adequate cleaning system at Jubilant Life Science Spokane, Washington State facility, in a recent Warning Letter issued to the firm.
Most new drug candidates suffer from poor water- solubility leading to rate limiting dissolution, slow absorption and limited bioavail...
Excipients designed to enhance skin penetration can maximize the efficacy of topical formulations. Through lipid disruption and...
For the past few years, controlled nucleation during the freeze drying process has been a subject of great interest to the bio-pharm c...