18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.
10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.
10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.
10-Dec-2014 - Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.
03-Dec-2014 - SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.
03-Dec-2014 - Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland.
03-Dec-2014 - The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.
02-Dec-2014 - [View the story "Live from CPHI India" on Storify]
27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.
26-Nov-2014 - With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.
24-Nov-2014 - The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.
24-Nov-2014 - BASF says the supply of API to GSK and other pharma customers will not be affected by the divestment of an omega-3 production plant in Norway.
19-Nov-2014 - The US Government has asked drugmakers and fine chemicals firms if laws designed to stop the proliferation of chemical weapons are hurting legitimate business.
12-Nov-2014 - Cadila Pharmaceuticals was cited by the US FDA for failing to respond appropriately and to correct issues related to customer complaints.
11-Nov-2014 - Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.
10-Nov-2014 - Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.
04-Nov-2014 - A generic version of Viagra launched in China contains the same amount of sildenafil citrate for a fraction of the price according to manufacturer Guangzhou Baiyuanshan Pharmaceutical Holdings (GBPH).
03-Nov-2014 - Warburg Pincus has bought a 32% stake in Indian API maker Laurus Labs Private Limited citing the ARV drug ingredients market and international opportunities as drivers.
30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.
28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.
27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives
23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build...
Drugmakers that include China in multi-regional trials will need to submit dossiers filed elsewhere for review, open...
Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the...
Singaporean companies are looking for scientists, while China and India need execs – but don’t count on...
With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its...
BASF says the supply of API to GSK and other pharma customers will not be affected by...