Globalisation

EXCLUSIVE

GDUFA means a level playing field for generics makers, says SOCMA

04-Jun-2012 - The new Generic Drugs User Fee Act (GDUFA) means a “level playing field” for drugmakers, according to SOCMA members.

FDA's new User Fee Bill spurs hopes for safer overseas supply chain

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....

Drop “outmoded” training to boost GMP compliance; study

30-May-2012 - Many biopharma firms can improve their GMP compliance efforts by dropping “outmoded” training measures, a report found.

UPDATE

Shortage of Indian gelatin makers could be "tremendous" opportunity for foreign firms, says IPEC

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.

Round-up of new pharmaceutical manufacturing facilities

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...

ICH sends Q11 guidelines to EU, US & Japanese regulators

14-May-2012 - The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.

New dry powder inhaler will improve delivery, says Aptar

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.

Indian minister rails against anti-generics smear campaign

09-May-2012 - The Indian government says multinational companies are running “a concerted campaign” against its generics industry.

Interactive map of fiscal 2011 FDA cGMP warning letters

26-Apr-2012 - In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.

FDA sent 40% more warning letters to overseas sites in ‘11

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.

EC offers €2m prize for system to improve vaccine stability

19-Apr-2012 - The European Commission is offering a €2m prize to anyone who can keep vaccines stable at any ambient temperature.

USP forges closer ties with South Korean FDA

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.

FDA compliance IT setup needs “considerable work”, GAO says

18-Apr-2012 - The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.

Merck tells FDA a clearer crude heparin definition is needed

16-Apr-2012 - Merck & Co has asked the FDA for a “clear and unambiguous” definition of crude heparin to improve draft guidance.

Pharmaniaga lays plans for API plant in "promising" Indonesia

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.

IOM calls on G20 to strengthen emerging market regulators

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.

FDA finds more counterfeit Roche oncology drugs in US

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.

FDA welcomes joiners to API regulatory sharing scheme

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.

UPDATE

New Turkish manufacturing plant for Novartis?

03-Apr-2012 - Novartis has established a new headquarters in Turkey, and and says its hopes to build a manufacturing plant in the area.

FDA hits two Mexican firms with GMP warning letters

28-Mar-2012 - The FDA has hit two Mexican companies with GMP warning letters six months after inspectors visited the country.

More than 80% of Nigerian anti-malarials fail USP tests; study

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.

FDA keeps estimate of online facility registration time burden

26-Mar-2012 - The US FDA is keeping its estimate of the burden imposed by electronic facility registration despite some industry opposition.

Indian dominance of CEP suspension list reflects inspection policy says EDQM

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...

Ranbaxy stakes claim on African drugs production market with new Moroccan plant

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.