When national businesses become global operations… With the industry sourcing more raw materials and services from around the world and distributing its products in new markets, companies are adapting their business processes to suit a more complex global operating environment.
04-Jun-2012 - The new Generic Drugs User Fee Act (GDUFA) means a “level playing field” for drugmakers, according to SOCMA members.
30-May-2012 - The US drug industry has welcomed news that Senate has passed the FDA’s amended User Fee Reauthorization Bill in the hopes it will mean a safer global supply chain....
30-May-2012 - Many biopharma firms can improve their GMP compliance efforts by dropping “outmoded” training measures, a report found.
24-May-2012 - IPEC (International Pharmaceutical Excipients) Federation is calling on foreign gelatin makers to set up manufacturing plants in India in a bid to tackle an “acute” shortage of the excipient.
16-May-2012 - in-PharmaTechnologist.com presents the latest new facilities to spring up all over the world, including a plasma-based therapy expansion for Baxter, a North African foray for Julphar, and a supply chain...
14-May-2012 - The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.
09-May-2012 - Aptar Pharma has launched a new twistable dry powder inhaler (DPI) which it says is a “cost effective” way to improve drug delivery as well as patient compliance.
09-May-2012 - The Indian government says multinational companies are running “a concerted campaign” against its generics industry.
26-Apr-2012 - In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.
24-Apr-2012 - The FDA sent 40 per cent more GMP warning letters to biopharma facilities outside the US in fiscal 2011 than the previous year.
19-Apr-2012 - The European Commission is offering a €2m prize to anyone who can keep vaccines stable at any ambient temperature.
18-Apr-2012 - The United States Pharmacopoeia (USP) has agreed to work with the South Korea Food and Drug Administration (KFDA) on the quality of medicines under an MOU signed this week.
18-Apr-2012 - The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.
16-Apr-2012 - Merck & Co has asked the FDA for a “clear and unambiguous” definition of crude heparin to improve draft guidance.
11-Apr-2012 - Malaysian drugmaker Pharmaniaga wants to buy an API plant in Indonesia, touting the country as the most “promising” of the pharmerging economies.
05-Apr-2012 - The G20 should add investment in developing countries’ regulatory systems to its agenda to secure the drug supply chain, an IOM report said.
04-Apr-2012 - The FDA has found counterfeits of a Roche oncology drug in US medical practices six weeks after the discovery of fake Avastin.
04-Apr-2012 - The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.
03-Apr-2012 - Novartis has established a new headquarters in Turkey, and and says its hopes to build a manufacturing plant in the area.
03-Apr-2012 - The PIC/S has published a document to harmonise how inspectors assess quality risk management as detailed in ICH Q9.
28-Mar-2012 - The FDA has hit two Mexican companies with GMP warning letters six months after inspectors visited the country.
27-Mar-2012 - More than four-fifths of anti-malarials sampled in Nigeria failed to meet USP specifications for one of the APIs, researchers found.
26-Mar-2012 - The US FDA is keeping its estimate of the burden imposed by electronic facility registration despite some industry opposition.
21-Mar-2012 - Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside...
14-Mar-2012 - Generics and API maker Ranbaxy has opened a plant in Casablanca, Morocco in a bid to strengthen its foothold in the “increasingly important” North African drugs market.